Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 42785 Insp GMP/GDP 42785/13455310-0006

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1

Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

The competent authority of United Kingdom confirms the following :

The Manufacturer : ACTIVE PHARMA SUPPLIES LIMITED

Site address : ACTIVE PHARMA SUPPLIES LIMITED, UNIT 2, FORWARD INDUSTRIAL ESTATE, TALBOT ROAD, LEYLAND, PR25 2ZJ, UNITED KINGDOM

Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 20/05/2021, it is considered that it complies with

The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.

(1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.

(2) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

[1000009680] NIFEDIPINE
[1000004605] CHLOROTHIAZIDE
[2000012211] MAGNESIUM GLYCEROPHOSPHATE
[2000006529] FLUDROCORTISONE ACETATE
[1000006699] CARBIMAZOLE
[3000006351] ACETYLSALICYLIC ACID
[1000009291] ACRIFLAVINE
[1000009902] PHENOL
[1000009790] PRILOCAINE
[2000007323] HYOSCINE HYDROBROMIDE
[2000008095] CHLORPHENIRAMINE MALEATE
[2000013292] LEVOTHYROXINE SODIUM
[3000004673] L-ARGININE
[2000007496] FORMALDEHYDE SOLUTION
[3000006207] ALIMEMAZINE
[4000006254] GLUCOSE MONOHYDRATE
[1000007341] LANSOPRAZOLE
[1000005193] CHLORAL HYDRATE
[4000013814] BETAMETHASONE DIPROPIONATE MICRONISED
[2000011380] COAL TAR SOLUTION
[1000008377] IODINE
[1000009308] TRANEXAMIC ACID
[4000003169] CHLORHEXIDINE DIGLUCONATE SOLUTION 20%
[2000007395] SULPHACETAMIDE SODIUM
[1000009160] BENZOCAINE
[1000009810] POTASSIUM IODIDE
[4000007084] SODIUM CROMOGLICATE
[1000009540] SODIUM BICARBONATE
[1000003125] ALUM
[1000011976] METHOTREXATE
[3000010012] SODIUM HYDROGEN CARBONATE
[1000009080] RAMIPRIL
[2000016109] ESTRADIOL VALERATE
[2000008522] AMITRIPTYLINE HYDROCHLORIDE
[1000008348] ATORVASTATIN
[1000002932] TOPIRAMATE
[2000008318] OXYBUTYNIN HYDROCHLORIDE
[3000010908] TRISODIUM CITRATE
[4000004550] MAGNESIUM SULPHATE EXSICCATED
[2000008238] NALOXONE HYDROCHLORIDE
[3000010904] CICLOSPORIN
[1000004660] CHLOROCRESOL
[1000000731] MELATONIN
[1000000859] MESALAZINE
[1000008752] HYDROQUINONE
[1000009531] SODIUM HYDROXIDE
[2000008485] VANCOMYCIN HYDROCHLORIDE
[2000008586] TRIAMCINOLONE ACETONIDE
[3000020819] TRETINOIN MICRONISED
[2000008543] ADRENALINE ACID TARTRATE
[1000009551] SILVER NITRATE
[1000000832] MINOXIDIL
[2000008358] BETAMETHASONE VALERATE
[2000007855] DANTROLENE SODIUM
[2000008278] BUPIVACAINE HYDROCHLORIDE
[1000007415] FINASTERIDE
[1000009383] SULPHUR
[2000007843] DEXAMETHASONE SODIUM PHOSPHATE
[2000008399] ZINC OXIDE
[2000007425] GLACIAL ACETIC ACID
[1000000947] MERCAPTOPURINE
[1000009387] SULPHASALAZINE
[1000009119] AMLODIPINE
[2000008390] FLUOXETINE HYDROCHLORIDE
[2000014083] LIDOCAINE HYDROCHLORIDE
[2000008780] HYDROGEN PEROXIDE SOLUTION 6%
[3000010117] SODIUM DIHYDROGEN PHOSPHATE
[1000009800] POVIDONE-IODINE
[1000001953] GRISEOFULVIN
[2000008014] CLOBETASOL PROPIONATE
[2000007815] QUININE HYDROCHLORIDE
[2000008378] SERTRALINE HYDROCHLORIDE
[2000007490] GENTAMICIN SULPHATE
[1000012475] TETRACAINE
[1000006766] CARBACHOL
[2000007515] FLECAINIDE ACETATE
[1000006787] CAPTOPRIL
[1000009661] NYSTATIN
[1000008740] AMIODARONE
[1000007745] ISONIAZID
[2000010983] BENZALKONIUM CHLORIDE
[2000008271] CAFFEINE CITRATE
[4000003578] NORADRENALINE TARTRATE
[2000007763] DILTIAZEM HYDROCHLORIDE
[2000007893] PROPANTHELINE BROMIDE
[1000001131] METRONIDAZOLE
[1000009849] ATENOLOL
[4000010992] METHYLCOBALAMIN
[1000007908] LEVODOPA
[4000007351] CHLORHEXIDINE DIACETATE
[2000008097] CHLOROQUINE PHOSPHATE
[4000011052] SODIUM GLYCEROPHOSPHATE HYDRATE
[1000000458] MANNITOL
[2000008257] MEXILETINE HYDROCHLORIDE
[2000007475] SODIUM VALPROATE
[3000004664] OXETACAINE
[1000005173] CHLORAMPHENICOL
[2000011773] GLYCOPYRRONIUM BROMIDE
[4000014216] COAL TAR SOLUTION STRONG
[1000009101] OMEPRAZOLE
[1000003204] DIAZOXIDE
[2000013668] CLOPIDOGREL BESILATE
[1000009821] POTASSIUM BROMIDE
[1000013818] LEVOMEPROMAZINE
[4000000347] CAMPHOR RACEMIC
[1000009812] POTASSIUM HYDROXIDE
[1000007419] SODIUM THIOSULPHATE
[1000013957] PENTOXIFYLLINE
[2000008175] NEOMYCIN SULPHATE
[1000009822] POTASSIUM BICARBONATE
[1000009609] PARACETAMOL
[3000011086] MENTHOL CRYSTALS
[2000008067] PHENYLEPHRINE HYDROCHLORIDE
[1000009500] BENZYL BENZOATE
[1000007337] BORIC ACID
[4000006807] ZINC SULPHATE HEPTAHYDRATE
[4000010966] PYRIDOXINE HYDROCHLORIDE
[1000008543] LORAZEPAM
[2000008411] MEDROXYPROGESTERONE ACETATE
[2000008429] MAGNESIUM CARBONATE LIGHT
[1000009535] SODIUM CITRATE
[1000008918] IBUPROFEN
[2000008446] ATROPINE SULPHATE
[2000007814] QUININE SULPHATE
[1000009436] SPIRONOLACTONE
[1000009143] BENZOIC ACID
[2000008199] CAPSICUM TINCTURE
[3000004479] CITRIC ACID ANHYDROUS
[1000004182] CLIOQUINOL
[2000008425] MAGNESIUM OXIDE HEAVY
[1000003230] ZONISAMIDE
[2000007877] LOSARTAN POTASSIUM
[2000007672] ENALAPRIL MALEATE
[2000008022] CITRIC ACID MONOHYDRATE
[3000017598] PHENYTOIN POWDER
[1000009347] THEOPHYLLINE
[2000007338] HYDROCORTISONE ACETATE
[2000008003] PILOCARPINE NITRATE
[2000008414] MEBEVERINE HYDROCHLORIDE
[1000008469] SIROLIMUS
[1000002416] TEMOZOLOMIDE
[2000008004] PILOCARPINE HYDROCHLORIDE
[3000017596] BISACODYL POWDER
[2000007914] PREDNISOLONE SODIUM PHOSPHATE
[1000009733] RESORCINOL
[1000006709] CARBIDOPA
[1000008905] ICHTHAMMOL
[2000006954] SILDENAFIL CITRATE
[2000007813] RANITIDINE HYDROCHLORIDE
[2000008338] METFORMIN HYDROCHLORIDE
[1000004479] CHOLESTEROL
[3000016930] L-CITRULLINE
[1000009303] TRETINOIN
[1000008566] LOPERAMIDE
[1000000894] MAGNESIUM HYDROXIDE
[2000008319] PAROXETINE HYDROCHLORIDE
[2000007324] HYOSCINE BUTYLBROMIDE
[1000013004] COAL TAR
[2000012207] MAGNESIUM CHLORIDE
[1000006286] CETRIMIDE
[4000009826] FERROUS SULPHATE HEPTAHYDRATE
[2000007753] DISODIUM EDETATE
[2000007511] FLUOCINOLONE ACETONIDE
[2000007992] PODOPHYLLUM RESIN
[4000009924] MAGNESIUM SULPHATE HEPTAHYDRATE
[3000010308] HYDROCORTISONE MICRONISED
[1000000149] METHYL SALICYLATE
[1000009751] PYRAZINAMIDE
[1000009817] POTASSIUM CITRATE
[2000013061] SODIUM BENZOATE
[1000007496] CALAMINE
[2000007900] PROFLAVINE HEMISULPHATE
[1000003322] DEXPANTHENOL
[2000016490] TACROLIMUS MONOHYDRATE
[1000009536] SODIUM CHLORIDE
[1000009653] OLEIC ACID
[1000008346] KETOPROFEN
[4000010937] THIAMINE HYDROCHLORIDE
[1000008715] SODIUM CYCLAMATE
[4000009250] GLUCOSE ANHYDROUS
[2000008504] LIOTHYRONINE SODIUM
[1000009262] UREA
[1000007411] AZELAIC ACID
[1000009710] SALICYLIC ACID
[4000007498] CALCIUM CARBONATE HEAVY
[2000007870] VENLAFAXINE HYDROCHLORIDE
[1000008354] ISOPROPYL MYRISTATE
[2000007383] TERBUTALINE SULPHATE
[2000007824] PYRIDOSTIGMINE BROMIDE
[2000008376] BECLOMETHASONE DIPROPIONATE
[1000009091] ZOPICLONE
[3000010996] ALUMINIUM OXIDE HYDRATED
[1000000391] NADOLOL
[2000013094] SODIUM OXYBATE
[1000009818] POTASSIUM CHLORIDE
[1000007367] BISOPROLOL
[2000007906] PROCAINE HYDROCHLORIDE
[2000008064] PHENYTOIN SODIUM
[2000008500] LISINOPRIL DIHYDRATE
[1000007071] TRICHLOROACETIC ACID
[2000008016] CLINDAMYCIN PHOSPHATE
[1000008764] HYDROCHLOROTHIAZIDE
[1000009411] SUCRALFATE
[1000002937] DITHRANOL
[1000015338] LIDOCAINE
[4000002915] 5-AMINOLEVULINIC ACID HYDROCHLORIDE
[1000003843] ALLOPURINOL

Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
NIFEDIPINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLOROTHIAZIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM GLYCEROPHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FLUDROCORTISONE ACETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CARBIMAZOLE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ACETYLSALICYLIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ACRIFLAVINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PHENOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PRILOCAINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYOSCINE HYDROBROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLORPHENIRAMINE MALEATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Primary and Secondary Repackaging only
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LEVOTHYROXINE SODIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
L-ARGININE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FORMALDEHYDE SOLUTION
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ALIMEMAZINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
GLUCOSE MONOHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LANSOPRAZOLE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLORAL HYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BETAMETHASONE DIPROPIONATE MICRONISED
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
COAL TAR SOLUTION
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
IODINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRANEXAMIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLORHEXIDINE DIGLUCONATE SOLUTION 20%
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SULPHACETAMIDE SODIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BENZOCAINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POTASSIUM IODIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM CROMOGLICATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM BICARBONATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ALUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
METHOTREXATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM HYDROGEN CARBONATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
RAMIPRIL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ESTRADIOL VALERATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
AMITRIPTYLINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ATORVASTATIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TOPIRAMATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
OXYBUTYNIN HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRISODIUM CITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM SULPHATE EXSICCATED
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
NALOXONE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CICLOSPORIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLOROCRESOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MELATONIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MESALAZINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYDROQUINONE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM HYDROXIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
VANCOMYCIN HYDROCHLORIDE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRIAMCINOLONE ACETONIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRETINOIN MICRONISED
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ADRENALINE ACID TARTRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SILVER NITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MINOXIDIL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BETAMETHASONE VALERATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DANTROLENE SODIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BUPIVACAINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FINASTERIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SULPHUR
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DEXAMETHASONE SODIUM PHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ZINC OXIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
GLACIAL ACETIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MERCAPTOPURINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SULPHASALAZINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
AMLODIPINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FLUOXETINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LIDOCAINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYDROGEN PEROXIDE SOLUTION 6%
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM DIHYDROGEN PHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POVIDONE-IODINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
GRISEOFULVIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CLOBETASOL PROPIONATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
QUININE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SERTRALINE HYDROCHLORIDE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
	3.5.4 Other Only re packaging option required, none of the above applicable.
GENTAMICIN SULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TETRACAINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CARBACHOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FLECAINIDE ACETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CAPTOPRIL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
NYSTATIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
AMIODARONE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ISONIAZID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BENZALKONIUM CHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CAFFEINE CITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
NORADRENALINE TARTRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DILTIAZEM HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PROPANTHELINE BROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
METRONIDAZOLE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ATENOLOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
METHYLCOBALAMIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LEVODOPA
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLORHEXIDINE DIACETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLOROQUINE PHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM GLYCEROPHOSPHATE HYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MANNITOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MEXILETINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM VALPROATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
OXETACAINE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHLORAMPHENICOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
GLYCOPYRRONIUM BROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
COAL TAR SOLUTION STRONG
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
OMEPRAZOLE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DIAZOXIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CLOPIDOGREL BESILATE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
	3.5.4 Other Only re packaging option required, none of the above applicable.
POTASSIUM BROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LEVOMEPROMAZINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CAMPHOR RACEMIC
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POTASSIUM HYDROXIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM THIOSULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PENTOXIFYLLINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
NEOMYCIN SULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POTASSIUM BICARBONATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PARACETAMOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MENTHOL CRYSTALS
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PHENYLEPHRINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BENZYL BENZOATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BORIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ZINC SULPHATE HEPTAHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PYRIDOXINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LORAZEPAM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MEDROXYPROGESTERONE ACETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM CARBONATE LIGHT
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM CITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
IBUPROFEN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ATROPINE SULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
QUININE SULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SPIRONOLACTONE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BENZOIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CAPSICUM TINCTURE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CITRIC ACID ANHYDROUS
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CLIOQUINOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM OXIDE HEAVY
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ZONISAMIDE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LOSARTAN POTASSIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ENALAPRIL MALEATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CITRIC ACID MONOHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PHENYTOIN POWDER
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
THEOPHYLLINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYDROCORTISONE ACETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PILOCARPINE NITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MEBEVERINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SIROLIMUS
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TEMOZOLOMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PILOCARPINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BISACODYL POWDER
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PREDNISOLONE SODIUM PHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
RESORCINOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CARBIDOPA
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ICHTHAMMOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SILDENAFIL CITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
RANITIDINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
METFORMIN HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CHOLESTEROL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
L-CITRULLINE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRETINOIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LOPERAMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM HYDROXIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PAROXETINE HYDROCHLORIDE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYOSCINE BUTYLBROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
COAL TAR
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM CHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CETRIMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FERROUS SULPHATE HEPTAHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DISODIUM EDETATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
FLUOCINOLONE ACETONIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PODOPHYLLUM RESIN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
MAGNESIUM SULPHATE HEPTAHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYDROCORTISONE MICRONISED
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
METHYL SALICYLATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PYRAZINAMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POTASSIUM CITRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM BENZOATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CALAMINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PROFLAVINE HEMISULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DEXPANTHENOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TACROLIMUS MONOHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM CHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
OLEIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
KETOPROFEN
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
THIAMINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM CYCLAMATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
GLUCOSE ANHYDROUS
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LIOTHYRONINE SODIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
UREA
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
AZELAIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SALICYLIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CALCIUM CARBONATE HEAVY
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
VENLAFAXINE HYDROCHLORIDE
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ISOPROPYL MYRISTATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TERBUTALINE SULPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PYRIDOSTIGMINE BROMIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BECLOMETHASONE DIPROPIONATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ZOPICLONE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ALUMINIUM OXIDE HYDRATED
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
NADOLOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SODIUM OXYBATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
POTASSIUM CHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
BISOPROLOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PROCAINE HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
PHENYTOIN SODIUM
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LISINOPRIL DIHYDRATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
TRICHLOROACETIC ACID
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
CLINDAMYCIN PHOSPHATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
HYDROCHLOROTHIAZIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
SUCRALFATE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
DITHRANOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
LIDOCAINE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
5-AMINOLEVULINIC ACID HYDROCHLORIDE
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging
ALLOPURINOL
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.4 Other Only re packaging option required, none of the above applicable.
3.5	General Finishing Steps
	3.5.2 Primary Packaging
	3.5.3 Secondary Packaging

Contact Details
12/10/2021	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential

Download PDF

Back to search