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 | 04/04/2025 |
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
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
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
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 |
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
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
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
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 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 |
| 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 | ||
| POTASSIUM CITRATE (1000009817) | |||
| SULPHAMETHOXAZOLE (1000009392) | |||
| BENZOCAINE (1000009160) | |||
| CAMPHOR (1000006857) | |||
| QUINIDINE SULPHATE (2000007818) | |||
| ADENOSINE (1000009941) | |||
| QUININE SULPHATE (2000007814) | |||
| AMMONIUM CHLORIDE (1000008021) | |||
| QUININE BISULPHATE (2000007817) | |||
| HYDROQUINONE (1000008752) | |||
| MAGNESIUM SULPHATE (2000012215) | |||
| FUROSEMIDE (3000005943) | |||
| LIDOCAINE HYDROCHLORIDE (2000014083) | |||
| DISODIUM INOSINATE (2000002607) | |||
| GLUCOSE ANHYDROUS (4000009250) | |||
| SIMVASTATIN (1000009116) | |||
| COLISTIN SULPHATE (2000011410) | |||
| AMETHOCAINE HYDROCHLORIDE (4000009244) | |||
| PHENOBARBITONE (3000014222) | |||
| QUININE DIHYDROCHLORIDE (2000007816) | |||
| MANGANESE GLUCONATE DIHYDRATE (2000016990) | |||
| PHENOBARBITONE SODIUM (4000007414) | |||
| THIORIDAZINE HYDROCHLORIDE (2000008605) | |||
| ETHAMBUTOL (1000002667) | |||
| SULPHATHIAZOLE (1000009386) | |||
| MAGNESIUM CARBONATE (1000001080) | |||
| PROPANTHELINE BROMIDE (2000007893) | |||
| CHLORPHENIRAMINE MALEATE (2000008095) | |||
| BORIC ACID (1000007337) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| CAMPHORATED OPIUM TINCTURE (1000006847) | |||
| CHLORAMPHENICOL (1000005173) | |||
| GLYCOPYRROLATE (4000009718) | |||
| IODINE (1000008377) | |||
| ZINC CARBONATE (1000006514) | |||
| QUININE HYDROCHLORIDE (2000007815) | |||
| AMPHOTERICIN B (1000012483) | |||
| PROCAINE HYDROCHLORIDE (2000007906) | |||
| LEVOTHYROXINE SODIUM (2000013292) | |||
| PROPYLTHIOURACIL (2000013274) | |||
| HYOSCINE BUTYLBROMIDE (2000007324) | |||
| SODIUM VALPROATE (2000007475) | |||
| GLUCOSE FOR ORAL USE (3000013581) | |||
| RANITIDINE HYDROCHLORIDE (2000007813) | |||
| ISONIAZID (1000007745) | |||
| MENTHOL (1000001243) | |||
| POTASSIUM CHLORIDE (1000009818) | |||
| DITHRANOL (1000002937) | |||
| PRIMIDONE (1000009788) | |||
| ADRENALINE ACID TARTRATE (2000008543) | |||
| BORAX (1000007346) | |||
| NYSTATIN (1000009661) | |||
| CAFFEINE (1000007507) | |||
| TRIHEXYPHENIDYL HYDROCHLORIDE (4000006899) | |||
| TRETINOIN (1000009303) | |||
| PARALDEHYDE (1000009604) | |||
| AMMONIUM BICARBONATE (1000008234) | |||
| PILOCARPINE NITRATE (2000008003) | |||
| PHENYTOIN (1000009887) | |||
| ZINC ACETATE DIHYDRATE (4000006812) | |||
| NALIDIXIC ACID (1000000294) | |||
| CLOZAPINE (1000009115) | |||
| WARFARIN SODIUM (2000008471) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| METRONIDAZOLE (1000001131) | |||
| AMINOBENZOIC ACID (1000008964) | |||
| HISTAMINE PHOSPHATE (2000007402) | |||
| ZINC LACTATE (1000002917) | |||
| NALTREXONE HYDROCHLORIDE (2000007614) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| ATROPINE SULPHATE (2000008446) | |||
| PHYSOSTIGMINE SALICYLATE (2000006393) | |||
| AMINOCAPROIC ACID (1000007472) | |||
| TRIMETHOPRIM (1000009283) | |||
| HYOSCINE HYDROBROMIDE (2000007323) | |||
| BENZOIC ACID (1000009143) | |||
| DIPYRIDAMOLE (1000002962) | |||
| LEVODOPA (1000007908) | |||
| GABAPENTIN (1000007380) | |||
| NAPROXEN (1000009701) | |||
| ACETOMENAPHTHONE (2000014020) | |||
| DIGITOXIN (1000003099) | |||
| DIPROPHYLLINE (1000007226) | |||
| SULPHACETAMIDE SODIUM (2000007395) | |||
| PODOPHYLLUM RESIN (2000007992) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| HYDROCHLOROTHIAZIDE (1000008764) | |||
| BUPIVACAINE HYDROCHLORIDE (2000008278) | |||
| NIFEDIPINE (1000009680) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| CYCLIZINE HYDROCHLORIDE (2000007923) | |||
| ERGOCALCIFEROL (2000007667) | |||
| ASPIRIN (1000009870) | |||
| PAPAVERINE HYDROCHLORIDE (2000008091) | |||
| SALICYLIC ACID (1000009710) | |||
| HYDROCORTISONE (1000008762) | |||
| FERROUS SULPHATE HEPTAHYDRATE (4000009826) | |||
| MANGANESE SULPHATE MONOHYDRATE (4000009934) | |||
| TRANEXAMIC ACID (1000009308) | |||
| MAGNESIUM GLYCEROPHOSPHATE (2000012211) | |||
| GRISEOFULVIN (1000001953) | |||
| ALLOPURINOL (1000003843) | |||
| FOLIC ACID (1000001996) | |||
| AMITRIPTYLINE HYDROCHLORIDE (2000008522) | |||
| NICOTINIC ACID (1000009684) | |||
| OMEPRAZOLE (1000009101) | |||
| VANCOMYCIN HYDROCHLORIDE (2000008485) | |||
| MIDAZOLAM HYDROCHLORIDE (2000008252) | |||
| PYRAZINAMIDE (1000009751) | |||
| INDOMETHACIN (1000008682) | |||
| DIPHENHYDRAMINE HYDROCHLORIDE (2000007758) | |||
| DIMETHYL SULPHOXIDE (1000003017) | |||
| L-SERINE (3000004546) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| DEXAMETHASONE ACETATE (2000007846) | |||
| NEOMYCIN SULPHATE (2000008175) | |||
| BISACODYL (1000007386) | |||
| 5-AMINOLEVULINIC ACID HYDROCHLORIDE (4000002915) | |||
| CHLORAL HYDRATE (1000005193) | |||
| LOPERAMIDE HYDROCHLORIDE (2000008494) | |||
| LORAZEPAM (1000008543) | |||
| SODIUM CHLORIDE (1000009536) | |||
| PREDNISOLONE SODIUM PHOSPHATE (2000007914) | |||
| ARGININE HYDROCHLORIDE (2000008452) | |||
| METOPROLOL TARTRATE (2000008259) | |||
| SODIUM SALICYLATE (2000007480) | |||
| CHLOROCRESOL (1000004660) | |||
| CAFFEINE CITRATE (2000008271) | |||
| PARACETAMOL (1000009609) | |||
| POTASSIUM IODIDE (1000009810) | |||
| RESORCINOL (1000009733) | |||
| TESTOSTERONE (1000009354) | |||
| KETOCONAZOLE (1000008441) | |||
| SODIUM BICARBONATE (1000009540) | |||
| DILTIAZEM HYDROCHLORIDE (2000007763) | |||
| METHACHOLINE CHLORIDE (1000007170) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| CALAMINE (1000007496) | |||
| DIGOXIN (1000003095) | |||
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | |||
| NOSCAPINE HYDROCHLORIDE (2000008165) | |||
| SUCRALFATE (1000009411) | |||
| DANTROLENE SODIUM (2000007855) | |||
| ICHTHAMMOL (1000008905) | |||
| ZINC SULPHATE (2000008397) | |||
| DOPAMINE HYDROCHLORIDE (2000007688) | |||
| CAFFEINE AND SODIUM BENZOATE (1000001509) | |||
| GUAIPHENESIN (1000001931) | |||
| NICOTINAMIDE (2000012339) | |||
| PILOCARPINE HYDROCHLORIDE (2000008004) | |||