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 44014 |
| 2. Name or corporate name of registrant | UNIVERSAL PHARMA LIMITED |
| 3. Permanent or legal address of registrant | UNIVERSAL PHARMA LIMITED, PAJE HOUSE, 164 WEST WYCOMBE ROAD, HIGH WYCOMBE, HP12 3AE, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
UNIVERSAL PHARMA LIMITED , PAJE HOUSE, 164 WEST WYCOMBE ROAD, HIGH WYCOMBE, HP12 3AE, 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 | 05/06/2023 |
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
UNIVERSAL PHARMA LIMITED , PAJE HOUSE, 164 WEST WYCOMBE ROAD, HIGH WYCOMBE, HP12 3AE, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| NEOMYCIN SULFATE (4000014380) | YICHANG SANXIA PHARMACEUTICAL CO. LIMITED., NO. 8 ZIYANG ROAD, DIAJUN DISTRICT, YICHANG, HUBEI, CN-443002, CHINA |
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| ADENOSINE (1000009941) | WOCKHARDT LIMITED., PLOT NO. 138, GIDC ESTATE, ANKLESHWAR, DISTRICT BHARUCH, GUJARAT, IN 393002, INDIA |
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| DILTIAZEM HYDROCHLORIDE (2000007763) | DIVI?S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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| LEVAMISOLE HYDROCHLORIDE (2000006314) | NANJING WHITE WHALE PHARMACEUTICAL CO. LIMITED., 158 YU DAO STREET, NANJING, CN-210007, CHINA |
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| TRIHEXYPHENIDYL HYDROCHLORIDE (4000006899) | NATCO PHARMA LIMITED, CHEMICAL DIVISION, MEKAGUDA VILLAGE, NANDIGAMA MANDAL, RANGAREDDY DISTRICT, TELANGANA, IN-509 223, INDIA |
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| ENALAPRIL MALEATE (2000007672) | NEULAND LABORATORIES LIMITED., UNIT 1, SURVEY NO. 347, 473, 474, 490/2, VEERABHADRASWAMY TEMPLE ROAD, BONTHAPALLI VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, INDIA |
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| PHENOXYBENZAMINE HYDROCHLORIDE (2000008071) | APOTHECON PHARMACEUTICALS PVT 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 |
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| IPRATROPIUM BROMIDE (2000008626) | NEULAND LABORATORIES LIMITED., UNIT 1, SURVEY NO. 347, 473, 474, 490/2, VEERABHADRASWAMY TEMPLE ROAD, BONTHAPALLI VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, INDIA |
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| MELATONIN (1000000731) | SWATI SPENTOSE PRIVATE LIMITED, UNIT-I A-1/2102 & 2103, PHASE 111, G.I.D.C, VAPI, GUJARAT, IN-396195, INDIA |
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| CICLESONIDE (1000001273) | AARTI INDUSTRIES LIMITED, UNIT IV, PLOT NO E-50, MIDC, TALUKA PALGHAR, DISTRICT PALGHAR, TARAPUR, MAHARASHTRA, IN-401 506, INDIA |
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| DOMPERIDONE (1000002907) | VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 37/A, 38, 39 A & B , PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA |
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| CLOBETASONE BUTYRATE (2000008013) | AVIK PHARMACEUTICAL LIMITED, A-1/7 AND A-1/8, PHASE-1, GUJARAT INDUSTRIAL DEVELOPMENT CORPORATION AREA, VALSAD DISTRICT, VAPI, GUJURAT, IN-396195, INDIA |
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| ZOPICLONE (1000009091) | CALYX CHEMICALS AND PHARMACEUTICALS LIMITED, UNIT NO 110 MARWAH'S COMPLEX, KRISHNALAL MARWAH MARG , OFF SAKI VIHAR ROAD, ANDHERI (EAST), MUMBAI, MAHARASHTRA, IN-400072, INDIA |
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| PROCHLORPERAZINE MALEATE (2000007903) | AZICO BIOPHORE INDIA PRIVATE LIMITED, PLOT NO. 40/A, JN PHARMACITY, PARAWADA MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531021, INDIA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| NEOMYCIN SULFATE (4000014380) | |||
| ADENOSINE (1000009941) | |||
| DILTIAZEM HYDROCHLORIDE (2000007763) | |||
| AMILORIDE HYDROCHLORIDE (2000008529) | |||
| LEVAMISOLE HYDROCHLORIDE (2000006314) | |||
| ANISEED OIL (4000007310) | |||
| TRIHEXYPHENIDYL HYDROCHLORIDE (4000006899) | |||
| GLYCOPYRROLATE (4000009718) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| HISTAMINE PHOSPHATE (2000007402) | |||
| MENADIOL SODIUM DIPHOSPHATE (4000010996) | |||
| CHLORAL HYDRATE (1000005193) | |||
| PHENOXYBENZAMINE HYDROCHLORIDE (2000008071) | |||
| IPRATROPIUM BROMIDE (2000008626) | |||
| MELATONIN (1000000731) | |||
| TRIFLUOPERAZINE (1000009289) | |||
| DIFLUCORTOLONE VALERATE MICRONISED (4000016009) | |||
| CICLESONIDE (1000001273) | |||
| OXYTETRACYCLINE CALCIUM (2000008151) | |||
| CYCLIZINE (1000003549) | |||
| DOMPERIDONE (1000002907) | |||
| TRIENTINE HYDROCHLORIDE (4000015142) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| ZOPICLONE (1000009091) | |||
| CHAMOMILE TINCTURE (1000003184) | |||
| NYSTATIN (1000009661) | |||
| PROCHLORPERAZINE MALEATE (2000007903) | |||