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 43567 |
| 2. Name or corporate name of registrant | IMCD UK LIMITED |
| 3. Permanent or legal address of registrant | IMCD UK LIMITED, TIMES HOUSE, THROWLEY WAY, SUTTON, SM1 4AF, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
IMCD UK LIMITED, TIMES HOUSE, THROWLEY WAY, SUTTON, SM1 4AF, 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 | 20/05/2025 |
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
IMCD UK LIMITED, TIMES HOUSE, THROWLEY WAY, SUTTON, SM1 4AF, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| HYDROCORTISONE ACETATE (2000007338) | TIANJIN TIANYAO PHARMACEUTICALS, 19 XINYE 9TH STREET, WEST AREA OF TIANJIN ECONOMIC TECHNOLOGICAL DEVELOPMENT AREA, TIANJIN, CN-300 462, CHINA |
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| SPIRONOLACTONE (1000009436) | TIANJIN TIANYAO PHARMACEUTICALS, 19 XINYE 9TH STREET, WEST AREA OF TIANJIN ECONOMIC TECHNOLOGICAL DEVELOPMENT AREA, TIANJIN, CN-300 462, CHINA |
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| SIMVASTATIN (1000009116) | KREBS BIOCHEMICALS AND INDUSTRIES LIMITED, UNIT 2, KOTHAPALLI VILLAGE, KASIMKOTA MANDAL, VISAKHAPATNAM DISTRICT, ANDHRA PRADESH, IN-531 031, INDIA |
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| PROPRANOLOL HYDROCHLORIDE (2000007892) | IPCA LABORATORIES LIMITED, PO BOX 33, 13/603 MHOW-NEEMMUCH ROAD, VILLAGE SEJAWATA, RATLAM, MADHYA PRADESH, IN-457002, INDIA |
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| CALCIUM L-5-METHYLTETRAHYDROFOLATE (4000016072) | MOLCLONE LABS PRIVATE LIMITED, NO 2/200, SURVEY NUMBER 173/1A, 173/2 AND 173/3, SIRUMATHUR VILLAGE, PADAPPAI, SRIPERUMBUDUR TALUK, KANCHIPURAM DISTRICT, IN-601 301, INDIA |
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| IBUPROFEN (1000008918) | BASF CORPORATION, 5738 COUNTY ROAD 4, BISHOP, 78343-3308, UNITED STATES |
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| ALLANTOIN (1000004055) | ASHLAND SPECIALITY INGREDIENTS, 116 SUMMIT AVENUE, CHATHAM, 07928, UNITED STATES |
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| EMODEPSIDE (1000018388) | SICHUAN QINGMU PHARMACEUTICAL CO., LTD., NO. 55 SOUTH SHINJIANG AVENUE, EAST ECONOMIC DEVELOPMENT ZONE, DONGPO DISTRICT, MEISHAN, SICHUAN PROVINCE, CN-620036, CHINA |
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| FLURBIPROFEN (1000002036) | FDC LIMITED, 142-48 SWAMI VIVEKANAND ROAD, JOGESHWARI (WEST), Data Not Available, 400 102, INDIA |
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| SITAGLIPTIN PHOSPHATE MONOHYDRATE (2000019583) | BAJAJ HEALTH CARE LIMITED, UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, INDIA |
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| CALCIUM CARBONATE (2000008145) | LIQUID QUIMICA MEXICANA SA DE CV, KM 31.5 CARR. TLALEPLANTLA-CUAUTITLAN, COL. LOMA BONITA, CUAUATITLAN, MX-54800, MEXICO |
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| DIMETHYL SULPHOXIDE (1000003017) | GAYLORD CHEMICAL CO. LLC, 1880 FAIRLAWN ROAD, TUSCALOOSA, 35401, UNITED STATES |
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| METFORMIN HYDROCHLORIDE (2000008338) | EXEMED PHARMACEUTICALS, BLOCK NO. 628 A & B, ECP CANAL ROAD, VILLAGE LUNA, TALUKA PADRA, VADODARA, GUJARAT, IN-391 440, INDIA |
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| PREDNISOLONE (1000009794) | TIANJIN TIANYAO PHARMACEUTICALS, 19 XINYE 9TH STREET, WEST AREA OF TIANJIN ECONOMIC TECHNOLOGICAL DEVELOPMENT AREA, TIANJIN, CN-300 462, CHINA |
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| NIACINAMIDE (4000009993) | LONZA GUANGZHOU PHARMACEUTICAL LIMITED, 68 HUANGGE DADAOBEI, NANSHA DISTRICT, GUANGZHOU, GUANGDONG, CN-511 455, CHINA |
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| VITAMIN B1 (2000013931) | DSM NUTRITIONAL PRODUCTS INCORPORATED, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| METHYLPREDNISOLONE (1000000003) | TIANJIN TIANYAO PHARMACEUTICALS, 19 XINYE 9TH STREET, WEST AREA OF TIANJIN ECONOMIC TECHNOLOGICAL DEVELOPMENT AREA, TIANJIN, CN-300 462, CHINA |
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| PRIMIDONE (1000009788) | PROVENTUS LIFE SCIENCES PRIVATE LIMITED, C-9 INDUSTRIAL COMPLEX, MARAIMALAI NAGAR, CHENNAI, IN-603 209, INDIA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| SODIUM ASCORBATE (2000007558) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| SPIRONOLACTONE (1000009436) | |||
| SIMVASTATIN (1000009116) | |||
| NEOSTIGMINE METHYLSULFATE (4000006142) | |||
| VITAMIN D3 (4000006823) | |||
| VITAMIN A ACETATE (4000006831) | |||
| DEXPANTHENOL (1000003322) | |||
| PROPRANOLOL HYDROCHLORIDE (2000007892) | |||
| VITAMIN B12 (4000010986) | |||
| CALCIUM L-5-METHYLTETRAHYDROFOLATE (4000016072) | |||
| RIBOFLAVIN (4000010954) | |||
| CALCIUM PANTOTHENATE (4000010962) | |||
| ASCORBIC ACID (1000009903) | |||
| ALLANTOIN (1000004055) | |||
| SODIUM ALGINATE (2000011136) | |||
| DL-ALPHA TOCOPHERYL ACETATE (4000003498) | |||
| RIBOFLAVIN 5'-PHOSPHATE (4000016750) | |||
| D-BIOTIN (3000009891) | |||
| ZINC OXIDE (2000008399) | |||
| EMODEPSIDE (1000018388) | |||
| FLURBIPROFEN (1000002036) | |||
| PYRIDOXINE HYDROCHLORIDE (4000010966) | |||
| SITAGLIPTIN PHOSPHATE MONOHYDRATE (2000019583) | |||
| CALCIUM CARBONATE (2000008145) | |||
| VITAMIN K1 (4000011004) | |||
| DIMETHYL SULPHOXIDE (1000003017) | |||
| FOLIC ACID (1000001996) | |||
| DL-ALPHA-TOCOPHEROL (4000010485) | |||
| SODIUM BICARBONATE (1000009540) | |||
| BETACAROTENE EMULSION 20% (2000008758) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| D-PANTHENOL (3000007800) | |||
| THIAMINE HYDROCHLORIDE (4000010937) | |||
| PREDNISOLONE (1000009794) | |||
| 5-FLUOROURACIL (3000006377) | |||
| AMOROLFINE HYDROCHLORIDE (2000008298) | |||
| VITAMIN A PALMITATE (4000006828) | |||
| NIACINAMIDE (4000009993) | |||
| SODIUM CHLORIDE (1000009536) | |||
| VITAMIN B1 (2000013931) | |||
| METHYLPREDNISOLONE (1000000003) | |||
| CINCHOCAINE HYDROCHLORIDE (2000008025) | |||
| THIAMINE MONONITRATE (4000006559) | |||
| CALCIUM ASCORBATE (2000007886) | |||
| PRIMIDONE (1000009788) | |||