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

Registrant Details
1. Registration NumberUK API 17661
2. Name or corporate name of registrantPCCA 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
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

Name and address of the site

PCCA LIMITED, UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, NE42 6PX, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
THYROID
1000007072
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
AImportation
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)