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 17661 |
| 2. Name or corporate name of registrant | PCCA LIMITED |
| 3. Permanent or legal address of registrant | PCCA LIMITED, UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, NE42 6PX, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
PCCA LIMITED, UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, NE42 6PX, 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 | 10/06/2024 |
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
PCCA LIMITED, UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, NE42 6PX, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| 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 | |
| LEVOTHYROXINE SODIUM (2000013292) | EXCELLA GMBH & CO. KG, NUERNBERGER STRASSE 12, FEUCHT, D-90537, GERMANY |
MEDISCA INC., 6641 NORTH BELT LINE ROAD, UNIT 130, IRVING, 75063-6001, UNITED STATES |
|
| 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 |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| ESTRADIOL (1000017043) | ZHEJIANG XIANJU PHARMA, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA QINHUANGDAO ZIZHU PHARMACEUTICAL COMPANY LIMITED, NO. 10 LONGHAI ROAD, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, QINHUANGDAO, HEBEI PROVINCE, CN-066 004, CHINA YICHENG GOTO PHARMACEUTICALS, GROUP 1 GAOKENG, XIAOHE, YICHENG, HUBEI PROVINCE, CN 441400, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES MEDISCA PHARMACEUTIQUE INCORPORATION, 6090 HENRI BOURASSA BOULEVARD W, SAINT-LAURENT QC, H4R 3A6, CANADA |
|
| CHLORAL HYDRATE (1000005193) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| SODIUM VALPROATE (2000007475) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES KATWIJK CHEMIE B.V., SNIJDERSTRAAT 6, KATWIJK ZH, NL-2222 BA, NETHERLANDS |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| HYDROQUINONE (1000008752) | EASTMAN CHEMICAL COMPANY, 200 SOUTH WILCOX DRIVE, KINGSPORT, 37660, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| TRAMADOL HYDROCHLORIDE (2000008034) | GVK BIOSCIENCES PRIVATE LIMITED, PLOT NO. 28A, IDA NACHARAM, HYDERABAD, TELANGANA, IN-500076, INDIA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| MIRTAZAPINE ANHYDROUS (2000014212) | MEDISCA PHARMACEUTIQUE INCORPORATION, 6090 HENRI BOURASSA BOULEVARD W, SAINT-LAURENT QC, H4R 3A6, CANADA |
MEDISCA PHARMACEUTIQUE INCORPORATION, 6090 HENRI BOURASSA BOULEVARD W, SAINT-LAURENT QC, H4R 3A6, CANADA |
|
| TESTOSTERONE (1000009354) | JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP, SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| KETAMINE HYDROCHLORIDE (2000008609) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| PREGNENOLONE (1000011186) | JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP, SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| RASAGILINE MESYLATE (2000005590) | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 3109, G.I.D.C. INDUSTRIAL ESTATE, ANKLESHWAR, BHARUCH DISTRICT, GUJARAT, IN 393002, INDIA |
GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 3109, G.I.D.C. INDUSTRIAL ESTATE, ANKLESHWAR, BHARUCH DISTRICT, GUJARAT, IN 393002, INDIA |
|
| HYDROCORTISONE ACETATE (2000007338) | TIANJIN JINJIN PHARMACEUTICAL COMPANY LIMITED, 8 JINGFU ROAD, ZHANGJIAWO TOWN INDUSTRIAL ZONE, XIQING DISTRICT ECONOMIC AND DEVELOPMENT AREA, ZHANGJIAWO, TIANJIN, CN-300380, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| BACLOFEN (1000009324) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| LOPERAMIDE HYDROCHLORIDE (2000008494) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| TRIAMCINOLONE 21-ACETATE (2000003684) | NEWCHEM S.P.A., VIA ROVEGGIA 47, VERONA, I-37136, ITALY |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| TRETINOIN (1000009303) | OLON SPA, VIA MILANO 186, GARBAGNATE MILANESE (MI), I-20024, ITALY |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| PROGESTERONE (1000009777) | JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP, SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA PHARMACIA & UPJOHN COMPANY LLC, 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| METHIMAZOLE (3000012191) | CHANGZHOU TIANHUA PHARMACEUTICAL CO LIMITED, NO. 3 HOUYANG CHEMICAL ZONE, GOLD TOWN, JINTAN, JIANGSU, CN-213200, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| ESTRIOL (3000004591) | QINHUANGDAO ZIZHU PHARMACEUTICAL COMPANY LIMITED, NO. 10 LONGHAI ROAD, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, QINHUANGDAO, HEBEI PROVINCE, CN-066 004, CHINA ZHEJIANG XIANJU PHARMA, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| NALTREXONE HYDROCHLORIDE (2000007614) | MALLINCKRODT CHEMICAL INCORPORATED, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| CLIOQUINOL (1000004182) | PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| PRASTERONE (1000006301) | JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP, SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| HYDROCHLOROTHIAZIDE (1000008764) | CHANGZHOU PHARMACEUTICAL FACTORY, 518 LAODONG EAST ROAD, CHANGZHOU, JIANGSU PROVINCE, CN-213018, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| FLUCONAZOLE (1000002222) | VIRUPAKSHA ORGANICS LIMITED, SURVEY NO 10, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, MEDAK DISTRICT, TELANGANA, IN-502 319, INDIA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| LIOTHYRONINE SODIUM (2000008504) | AZICO BIOPHORE INDIA PRIVATE LIMITED, PLOT NO. 40/A, JN PHARMACITY, PARAWADA MANDAL, ANAKAPALLI, ANDHRA PRADESH, IN-531021, INDIA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| THYROID (1000007072) | BIOIBERICA S.A.U, CARRER ANTIC CAMI DE TORDERA 109-119, PALAFOLLS, BARCELONA, E-08389, SPAIN |
||
| TACROLIMUS MONOHYDRATE (2000016490) | BIOCON LIMITED, 20TH KM HOSUR ROAD, ELECTRONICS CITY, BANGALORE, IN-560 100, INDIA |
BIOCON LIMITED, 20TH KM HOSUR ROAD, ELECTRONICS CITY, BANGALORE, IN-560 100, INDIA |
|
| SPIRONOLACTONE (1000009436) | ZHEJIANG LANGHUA PHARMACEUTICAL CO. LIMITED, ZHEJIANG PROVINCIAL CHEMICAL & MEDICAL MATERIALS BASE, LINHAI ZONE, LINHAI, ZHEJIANG PROVINCE, CN-317016, CHINA |
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA INCORPORATED, 9901 S. WILCREST DRIVE, HOUSTON, 77099, UNITED STATES |
|
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| THYROID (1000007072) | |||