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 4 |
| 2. Name or corporate name of registrant | GLAXO OPERATIONS UK LIMITED |
| 3. Permanent or legal address of registrant | GLAXO OPERATIONS UK LIMITED, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM GLAXOSMITHKLINE, COBDEN STREET, MONTROSE, DD10 8EA, UNITED KINGDOM GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJ, UNITED KINGDOM GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, NORTH LONSDALE ROAD, ULVERSTON, LA12 9DR, 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 | 05/12/2023 |
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
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| MEPOLIZUMAB (1000011081) | HUMAN GENOME SCIENCES INC., 14200 SHADY GROVE ROAD, ROCKVILLE, 20850, UNITED STATES |
||
| FLUTICASONE PROPIONATE (2000008220) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| CLINDAMYCIN PHOSPHATE (2000008016) | ZHEIJANG HISOAR PHARMACEUTICAL CO LIMITED, 1 HAIZHENG AVENUE, JIAOJIANG DISTRICT, TAIZHOU CITY, CN-318000, CHINA ZHEJIANG HISOAR PHARMACEUTICAL CO. LIMITED, NO. 23, 5TH DONGHAI AVENUE, ZHEJIANG CHEMICAL MATERIALS BASE LINHAI ZONE, LINHAI CITY, ZHEJIANG PROVINCE, CN-317016, CHINA |
||
| ZIDOVUDINE (1000009208) | AUROBINDO PHARMA LIMITED, UNIT VIII, SURVEY NO. 10 AND 13, GADDAPOTHARAM VILLAGE, IDA - KAZIPALLY, JINNARAM MANDAL, MEDAK DISTRICT, ANDHRA PRADESH, IN-502 319, INDIA |
||
| FLUTICASONE FUROATE (2000014516) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| HYDROCORTISONE (1000008762) | PHARMACIA & UPJOHN (PFIZER GLOBAL MANUFACTURING), 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
||
| NEOMYCIN SULPHATE (2000008175) | PHARMACIA & UPJOHN (PFIZER GLOBAL MANUFACTURING), 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
||
| ACICLOVIR (3000006349) | MYLAN LABORATORIES LIMITED, UNIT 7, PLOT NO 14, 99 AND 100, PHASE II, INDUSTRIAL DEVELOPMENT AREA PASHAMYLARAM, PATANCHERU, SANGAREDDY DISTRICT, TELANGANA, IN-502 307, INDIA |
||
| HYDROUS BENZOYL PEROXIDE (2000007330) | AKZO NOBEL CHEMICALS SA DE CV, 49 AVENUE MORELOS, COL. TECAMACHALCO, LOS REYES LA PAZ, MX-56500, MEXICO ARKEMA INC., 3289 GENESEE STREET, PIFFARD, 14533, UNITED STATES |
||
| CABOTEGRAVIR (1000017903) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| ZANAMIVIR (1000000992) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| RAXIBACUMAB (1000019199) | HUMAN GENOME SCIENCES INC., 14200 SHADY GROVE ROAD, ROCKVILLE, 20850, UNITED STATES |
||
| RANITIDINE HYDROCHLORIDE (2000007813) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| BELIMUMAB (1000011881) | HUMAN GENOME SCIENCES INC., 14200 SHADY GROVE ROAD, ROCKVILLE, 20850, UNITED STATES |
||
| OFATUMUMAB (1000011488) | LONZA, 101 INTERNATIONAL DRIVE, PORTSMOUTH, 03801, UNITED STATES |
||
| PARICALCITOL (1000017064) | SAFC PHARMA, 645 SCIENCE DRIVE, MADISON, 53711, UNITED STATES |
||
| ARGATROBAN MONOHYDRATE (2000015815) | MITSUBISHI TANABE PHARMA CORPORATION, 14 SUNAYAMA, HASAKI-MACHI, KASHIMA-GUN, IBARAKI-KEN, JP 314-0255, JAPAN |
||
| SUMATRIPTAN SUCCINATE (2000008222) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| FLUTICASONE PROPIONATE (2000008220) | |||
| ZIDOVUDINE (1000009208) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| ZANAMIVIR (1000000992) | |||
| CLOTRIMAZOLE (1000003999) | |||
GLAXOSMITHKLINE, COBDEN STREET, MONTROSE, DD10 8EA, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Sieving. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Sieving. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, micronisation. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation and salt formation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Sieving. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Sulphate salt formation and crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Sieving. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Rehumidification, Blending, Sieving | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Sieving. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| 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 | |
| ABACAVIR SULPHATE (2000005612) | PIRAMAL ENTERPRISES LIMITED, SURVEY NOS. 7-70, 70/1 AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, KOHIR CROSS ROAD, SANGAREDDY DISTRICT, TELANGANA, IN-502 321, INDIA |
||
| CLOBETASONE BUTYRATE (2000008013) | SYMBIOTEC PHARMALAB PVT LIMTED, PLOT NO. 385/2 PIGDAMBER, NEAR HOTEL MASHAL, OFF A B ROAD, RAU, INDORE DISTRICT, MADHYA PRADESH, IN-453331, INDIA |
||
| CLOBETASOL PROPIONATE (2000008014) | SYMBIOTEC PHARMALAB PVT LIMTED, PLOT NO. 385/2 PIGDAMBER, NEAR HOTEL MASHAL, OFF A B ROAD, RAU, INDORE DISTRICT, MADHYA PRADESH, IN-453331, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| VILANTEROL TRIFENATATE (4000013535) | |||
| LACIDIPINE (1000007375) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| ZANAMIVIR (1000000992) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| LAMOTRIGINE (1000009498) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| DUTASTERIDE (1000007791) | |||
GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJ, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation for GW Manufacturing and Shanghai Desano Chemical | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| DAPRODUSTAT (3000018715) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| PAZOPANIB (1000011372) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| FLUTICASONE PROPIONATE (2000008220) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| SALMETEROL XINAFOATE (2000008392) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| VILANTEROL TRIFENATATE (4000013535) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| DOLUTEGRAVIR SODIUM (4000014056) | SHIONOGI PHARMACHEMICALS CO. LIMITED, 224-20, HIRAISHIEBISUNO, KAWAUCHI-CHO, TOKUSHIMA, JP 771-0132, JAPAN GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE SHANGHAI DESANO CHEMICAL PHARMACEUTICAL COMPANY LIMITED, 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA |
GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
|
| DABRAFENIB MESYLATE (2000017501) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| LAMIVUDINE (1000003255) | ASTRIX LABORATORIES LIMITED, SURVEY NO 10/42 GADDAPATHARAM, KAZIPALLY, MEDAK DISTRICT, HYDERABAD, ANDHRA PRADESH, IN-502 319, INDIA GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
|
| ZIDOVUDINE (1000009208) | AUROBINDO PHARMA LIMITED, UNIT VIII, SURVEY NO. 10 &13, IDA - KAZIPALLY, JINNARAM MANDAL, SANGAREDDY DISTRICT, GADDAPOTHARAM, TELANGANA, IN-502 319, INDIA |
||
| FLUTICASONE FUROATE (2000014516) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| UMECLIDINIUM BROMIDE (4000014045) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| CABOTEGRAVIR SODIUM (2000017021) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| DAPRODUSTAT (3000018715) | |||
| PAZOPANIB (1000011372) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| DABRAFENIB MESYLATE (2000017501) | |||
| ELTROMBOPAG OLAMINE (2000018050) | |||
| LAMIVUDINE (1000003255) | |||
| FOSAMPRENAVIR (1000000423) | |||
| ZIDOVUDINE (1000009208) | |||
| ABACAVIR SULFATE (4000003016) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| CABOTEGRAVIR SODIUM (2000017021) | |||
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, NORTH LONSDALE ROAD, ULVERSTON, LA12 9DR, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.4 Other
Physical form conversion from crystalline to amorphous form via spray drying | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Spray drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CEFUROXIME AXETIL (2000008117) | |||