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 20416 |
| 2. Name or corporate name of registrant | CRESCENT PHARMA LIMITED |
| 3. Permanent or legal address of registrant | CRESCENT PHARMA LIMITED, KEY HOUSE, SARUM HILL, BASINGSTOKE, RG21 8SR, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
CRESCENT PHARMA LIMITED, CRESCENT HOUSE, CUNARD ROAD, LONDON, NW10 6PN, 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 | 14/03/2024 |
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
CRESCENT PHARMA LIMITED, CRESCENT HOUSE, CUNARD ROAD, LONDON, NW10 6PN, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| PHENOXYMETHYLPENICILLIN POTASSIUM (2000008070) | BIOTIKA A.S., PO BOX 976 13, SLOVENSKA L'UPCA, SK-566, SLOVAKIA |
||
| TRIMETHOPRIM (1000009283) | IPCA LABORATORIES LIMITED, 48 KANDIVLI INDUSTRIAL ESTATE, KANDIVLI (WEST), MUMBAI, IN-400 067, INDIA |
||
| ACETYLSALICYLIC ACID (3000006351) | SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA |
SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA |
|
| IBUPROFEN (1000008918) | SOLARA ACTIVE PHARMA SCIENCES LIMITED, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN-605014, INDIA |
||
| RANITIDINE (1000009740) | ORCHEV PHARMA PVT LIMITED, SHAPAR INDUSTRIAL AREA, N.H. 8-B, RAJKOT-GONDAL HIGHWAY, VERAVAL VILLAGE, RAJKOT DISTRICT, GUJARAT, IN 360024, INDIA |
||
| CAFFEINE (1000007507) | SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA |
SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA |
|
| SODIUM PICOSULFATE (3000010007) | KREATIVE, D-123, PHASE III, IDA, JEEDIMETLA VILLAGE, QUTHBULLAPUR MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500033, INDIA |
||
| ONDANSETRON (1000009100) | DR REDDY'S LABORATORIES LIMITED, 8-2-337, ROAD NO. 3, BANJARA HILLS, HYDERABAD, TELANGANA, IN-500034, INDIA |
||
| ATENOLOL (1000009849) | IPCA LABORATORIES LIMITED, 48 KANDIVLI INDUSTRIAL ESTATE, KANDIVLI (WEST), MUMBAI, IN-400 067, INDIA |
||
| BACLOFEN (1000009324) | PHARMACEUTICAL WORKS POLPHARMA S.A., 19 PELPLINSKA STREET, STAROGARD GDANSKI, PL-83-200, POLAND |
||
| PARACETAMOL (1000009609) | SRI KRISHNA PHARMACEUTICALS LIMITED, UNIT 1, C-4, INDUSTRIAL DEVELOPMENT AREA, UPPAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500039, INDIA |
||
| LEVETIRACETAM (1000013222) | ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
||
| AMOXICILLIN TRIHYDRATE (4000006303) | ANTIBIOTICOS SA, AVDA ANTIBIOTICOS 59-61, LEON, 24009, SPAIN |
||
| CHLORPHENAMINE MALEATE (4000007290) | SUPRIYA LIFE SCIENCE LIMITED, A-5/2 LOTE PARSHURAM INDUSTRIAL AREA, MIDC, TALUKA KHED, RATNAGIRI, MAHARASHTRA, IN-415 722, INDIA |
||
| FLUCLOXACILLIN SODIUM POWDER (4000013526) | FRESENIUS KABI IPSUM SRL, VIA SAN LEONARDO, 23, VILLADOSE (RO), I-45010, ITALY |
||
| LACTULOSE SOLUTION (2000008519) | BIOFAC A/S COPENHAGEN DENMARK, ENGLANDSVEJ 350-356, KASTRUP, DK-2770, DENMARK |
||
| CETRIMIDE (1000006286) | DISHMAN PHARMACEUTICALS & CHEMICALS LIMITED, PLOT NO 1216/11, 1216/24, 25 & 26, PHASE IV, GIDC ESTATE, NARODA, AHMEDABAD, IN-382 330, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PHENOXYMETHYLPENICILLIN POTASSIUM (2000008070) | |||
| TRIMETHOPRIM (1000009283) | |||
| LIQUID PARAFFIN (4000006486) | |||
| IBUPROFEN (1000008918) | |||
| RANITIDINE (1000009740) | |||
| CLOVE OIL (4000010430) | |||
| LIGHT LIQUID PARAFFIN (4000006491) | |||
| SODIUM PICOSULFATE (3000010007) | |||
| ONDANSETRON (1000009100) | |||
| ATENOLOL (1000009849) | |||
| WHITE SOFT PARAFFIN (4000006817) | |||
| BACLOFEN (1000009324) | |||
| PARACETAMOL (1000009609) | |||
| LEVETIRACETAM (1000013222) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| CHLORPHENAMINE MALEATE (4000007290) | |||
| FLUCLOXACILLIN SODIUM POWDER (4000013526) | |||
| LACTULOSE SOLUTION (2000008519) | |||
| CETRIMIDE (1000006286) | |||