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 6464 |
| 2. Name or corporate name of registrant | WAYMADE PLC |
| 3. Permanent or legal address of registrant | WAYMADE PLC, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
WAYMADE PLC, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 08/12/2023 |
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
WAYMADE PLC, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CARGLUMIC ACID (1000000807) | APOTHECON PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 1134, 1135, 1136, 1137, 1138-A& B, 1143-B, 1144-A&B, PADRA JAMBUSAR HIGHWAY, DABHASA, PADRA, VADODARA, GUJARAT, IN-391440, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| VERNAKALANT HYDROCHLORIDE (4000011628) | |||
| GRANISETRON (1000009464) | |||
| IMIPRAMINE HYDROCHLORIDE (2000007321) | |||
| ILOPROST TROMETAMOL (2000005630) | |||
| TERAZOSIN HYDROCHLORIDE DIHYDRATE (4000003614) | |||
| METHYLDOPA (1000000089) | |||
| HYDRALAZINE HYDROCHLORIDE (2000007339) | |||
| TOLBUTAMIDE (1000009315) | |||
| CALCITRIOL (2000013598) | |||
| CLOBAZAM (1000004171) | |||
| IBANDRONIC ACID (1000003268) | |||
| NAPROXEN SODIUM (2000008177) | |||
| BACLOFEN (1000009324) | |||
| CARGLUMIC ACID (1000000807) | |||
| AURANOFIN (2000007430) | |||
| BIPERIDEN HYDROCHLORIDE (2000008355) | |||
| CLIOQUINOL (1000004182) | |||
| MAPROTILINE HYDROCHLORIDE (2000008415) | |||
| BIPERIDEN (1000007396) | |||
| HYDROCORTISONE (1000008762) | |||
| ERYTHROMYCIN ETHYLSUCCINATE (4000006921) | |||
| ERYTHROMYCIN BASE (3000023536) | |||
| KETOROLAC TROMETHAMINE (4000003443) | |||
| SALICYLIC ACID (1000009710) | |||
| ATENOLOL (1000009849) | |||
| NITROFURANTOIN MACROCRYSTALS (3000007709) | |||
| PROPRANOLOL (1000009764) | |||
| SULFINPYRAZONE (3000009586) | |||
| OLSALAZINE SODIUM (2000008301) | |||
| NAPROXEN (1000009701) | |||
| NONOXYNOL 9 (4000006710) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| BENZYL BENZOATE (1000009500) | |||
| ERYTHROMYCIN STEARATE (2000007602) | |||
| DIAZEPAM (1000003208) | |||
| CHLORTHALIDONE (1000004490) | |||
| TETRACOSACTIDE ACETATE (4000006980) | |||
| FLUTAMIDE (1000009110) | |||
| CHLORAL BETAINE (2000006651) | |||
| HYDROCHLOROTHIAZIDE (1000008764) | |||
| GRANISETRON HYDROCHLORIDE (2000008148) | |||
| PIZOTIFEN (1000009852) | |||
| BISACODYL (1000007386) | |||
| ESTRIOL (3000004591) | |||
| SPIRONOLACTONE (1000009436) | |||
| LISINOPRIL DIHYDRATE (2000008500) | |||
| FAMCICLOVIR (1000007360) | |||
| CHLORAL HYDRATE (1000005193) | |||