Medicines and Healthcare products Regulatory Agency
REGISTRATION OF MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ACTIVE SUBSTANCES TO BE USED AS STARTING MATERIALS IN MEDICINAL PRODUCTS FOR HUMAN USE
| 1. Registration Number | UK API 24 |
| 2. Name or corporate name of registrant | COURTIN & WARNER LIMITED |
| 3. Permanent or legal address of registrant | COURTIN & WARNER LIMITED, UNIT F, MALLING BROOKS, BROOKS ROAD, LEWES, BN7 2QG, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
COURTIN & WARNER LIMITED, UNIT F, MALLING BROOKS, BROOKS ROAD, LEWES, BN7 2QG, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 17/04/2024 |
This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in MHRA-GMDP.
The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.
SCOPE OF REGISTRATION
Name and address of the site
COURTIN & WARNER LIMITED, UNIT F, MALLING BROOKS, BROOKS ROAD, LEWES, BN7 2QG, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
Active substance
SUCRALFATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Re-packer | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Repacker | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
Active substance
CAFFEINE CITRATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
ETHAMBUTOL
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Re-packer | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Repacking | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
Active substance
GABAPENTIN
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Re-packer | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Re-packer | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
Active substance
CAFFEINE AND SODIUM BENZOATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
PHENOBARBITONE SODIUM
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Repacker | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Re-packer | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
Active substance
LORAZEPAM
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Re-packer | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Repacker | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
Active substance
NYSTATIN
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Re-packer | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Re-packer | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| GLYCERYL TRINITRATE 2% IN LACTOSE (2000016989) | SCHWEIZERISCHE SPRENGSTOFF AG CHEDDITE, BAUENSTRASSE 5, BAUEN, CH-6466, SWITZERLAND |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| DILTIAZEM HYDROCHLORIDE (2000007763) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| NICOTINAMIDE (2000012339) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| ZINC SULPHATE (2000008397) | |||
| SIMVASTATIN (1000009116) | |||
| PREDNISOLONE SODIUM PHOSPHATE (2000007914) | |||
| RESORCINOL (1000009733) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| NIFEDIPINE (1000009680) | |||
| DIPYRIDAMOLE (1000002962) | |||
| DIGITOXIN (1000003099) | |||
| BISACODYL (1000007386) | |||
| PHENOBARBITONE (3000014222) | |||
| SODIUM VALPROATE (2000007475) | |||
| MENTHOL (1000001243) | |||
| DITHRANOL (1000002937) | |||
| GLUCOSE ANHYDROUS (4000009250) | |||
| KETOCONAZOLE (1000008441) | |||
| SULPHATHIAZOLE (1000009386) | |||
| GLYCOPYRROLATE (4000009718) | |||
| TRIHEXYPHENIDYL HYDROCHLORIDE (4000006899) | |||
| QUININE HYDROCHLORIDE (2000007815) | |||
| TRANEXAMIC ACID (1000009308) | |||
| SULPHAMETHOXAZOLE (1000009392) | |||
| HISTAMINE PHOSPHATE (2000007402) | |||
| CAMPHORATED OPIUM TINCTURE (1000006847) | |||
| METRONIDAZOLE (1000001131) | |||
| ADENOSINE (1000009941) | |||
| POTASSIUM CHLORIDE (1000009818) | |||
| MAGNESIUM CARBONATE (1000001080) | |||
| ACETOMENAPHTHONE (2000014020) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| TRETINOIN (1000009303) | |||
| SALICYLIC ACID (1000009710) | |||
| AMINOBENZOIC ACID (1000008964) | |||
| NALTREXONE HYDROCHLORIDE (2000007614) | |||
| NAPROXEN (1000009701) | |||
| VANCOMYCIN HYDROCHLORIDE (2000008485) | |||
| QUINIDINE SULPHATE (2000007818) | |||
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | |||
| MIDAZOLAM HYDROCHLORIDE (2000008252) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| NEOMYCIN SULPHATE (2000008175) | |||
| MAGNESIUM GLYCEROPHOSPHATE (2000012211) | |||
| SODIUM BICARBONATE (1000009540) | |||
| SUCRALFATE (1000009411) | |||
| PILOCARPINE NITRATE (2000008003) | |||
| POTASSIUM IODIDE (1000009810) | |||
| CAFFEINE CITRATE (2000008271) | |||
| FOLIC ACID (1000001996) | |||
| PODOPHYLLUM RESIN (2000007992) | |||
| DANTROLENE SODIUM (2000007855) | |||
| HYDROCORTISONE (1000008762) | |||
| L-SERINE (3000004546) | |||
| GUAIPHENESIN (1000001931) | |||
| PAPAVERINE HYDROCHLORIDE (2000008091) | |||
| SODIUM SALICYLATE (2000007480) | |||
| COLISTIN SULPHATE (2000011410) | |||
| GLUCOSE FOR ORAL USE (3000013581) | |||
| ETHAMBUTOL (1000002667) | |||
| CHLORAMPHENICOL (1000005173) | |||
| DIMETHYL SULPHOXIDE (1000003017) | |||
| CHLOROCRESOL (1000004660) | |||
| GABAPENTIN (1000007380) | |||
| DEXAMETHASONE ACETATE (2000007846) | |||
| METOPROLOL TARTRATE (2000008259) | |||
| 5-AMINOLEVULINIC ACID HYDROCHLORIDE (4000002915) | |||
| CAFFEINE AND SODIUM BENZOATE (1000001509) | |||
| IODINE (1000008377) | |||
| OMEPRAZOLE (1000009101) | |||
| BORIC ACID (1000007337) | |||
| AMITRIPTYLINE HYDROCHLORIDE (2000008522) | |||
| ISONIAZID (1000007745) | |||
| CYCLIZINE HYDROCHLORIDE (2000007923) | |||
| MANGANESE SULPHATE MONOHYDRATE (4000009934) | |||
| ICHTHAMMOL (1000008905) | |||
| ASPIRIN (1000009870) | |||
| LEVOTHYROXINE SODIUM (2000013292) | |||
| PYRAZINAMIDE (1000009751) | |||
| TRIMETHOPRIM (1000009283) | |||
| METHACHOLINE CHLORIDE (1000007170) | |||
| ZINC CARBONATE (1000006514) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| PARACETAMOL (1000009609) | |||
| ZINC LACTATE (1000002917) | |||
| AMPHOTERICIN B (1000012483) | |||
| CALAMINE (1000007496) | |||
| ARGININE HYDROCHLORIDE (2000008452) | |||
| PROPYLTHIOURACIL (2000013274) | |||
| FUROSEMIDE (3000005943) | |||
| TESTOSTERONE (1000009354) | |||
| AMINOCAPROIC ACID (1000007472) | |||
| ZINC ACETATE DIHYDRATE (4000006812) | |||
| AMMONIUM BICARBONATE (1000008234) | |||
| MANGANESE GLUCONATE DIHYDRATE (2000016990) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| DOPAMINE HYDROCHLORIDE (2000007688) | |||
| PROPANTHELINE BROMIDE (2000007893) | |||
| LIDOCAINE HYDROCHLORIDE (2000014083) | |||
| NOSCAPINE HYDROCHLORIDE (2000008165) | |||
| RANITIDINE HYDROCHLORIDE (2000007813) | |||
| PHENOBARBITONE SODIUM (4000007414) | |||
| POTASSIUM CITRATE (1000009817) | |||
| INDOMETHACIN (1000008682) | |||
| HYDROCHLOROTHIAZIDE (1000008764) | |||
| PHENYTOIN (1000009887) | |||
| CHLORAL HYDRATE (1000005193) | |||
| THIORIDAZINE HYDROCHLORIDE (2000008605) | |||
| LOPERAMIDE HYDROCHLORIDE (2000008494) | |||
| DIPHENHYDRAMINE HYDROCHLORIDE (2000007758) | |||
| ERGOCALCIFEROL (2000007667) | |||
| BUPIVACAINE HYDROCHLORIDE (2000008278) | |||
| CLOZAPINE (1000009115) | |||
| BENZOIC ACID (1000009143) | |||
| FERROUS SULPHATE HEPTAHYDRATE (4000009826) | |||
| MAGNESIUM SULPHATE (2000012215) | |||
| QUININE DIHYDROCHLORIDE (2000007816) | |||
| CHLORPHENIRAMINE MALEATE (2000008095) | |||
| LEVODOPA (1000007908) | |||
| LORAZEPAM (1000008543) | |||
| ADRENALINE ACID TARTRATE (2000008543) | |||
| ATROPINE SULPHATE (2000008446) | |||
| WARFARIN SODIUM (2000008471) | |||
| CAMPHOR (1000006857) | |||
| ALLOPURINOL (1000003843) | |||
| NYSTATIN (1000009661) | |||
| HYOSCINE HYDROBROMIDE (2000007323) | |||
| HYDROQUINONE (1000008752) | |||
| NICOTINIC ACID (1000009684) | |||
| SULPHACETAMIDE SODIUM (2000007395) | |||
| PILOCARPINE HYDROCHLORIDE (2000008004) | |||
| QUININE BISULPHATE (2000007817) | |||
| AMMONIUM CHLORIDE (1000008021) | |||
| BENZOCAINE (1000009160) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| SODIUM CHLORIDE (1000009536) | |||
| HYOSCINE BUTYLBROMIDE (2000007324) | |||
| DISODIUM INOSINATE (2000002607) | |||
| DIPROPHYLLINE (1000007226) | |||
| GRISEOFULVIN (1000001953) | |||
| PARALDEHYDE (1000009604) | |||
| AMETHOCAINE HYDROCHLORIDE (4000009244) | |||
| DIGOXIN (1000003095) | |||
| PROCAINE HYDROCHLORIDE (2000007906) | |||
| CAFFEINE (1000007507) | |||
| NALIDIXIC ACID (1000000294) | |||
| BORAX (1000007346) | |||
| PRIMIDONE (1000009788) | |||
| PHYSOSTIGMINE SALICYLATE (2000006393) | |||
| QUININE SULPHATE (2000007814) | |||