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, 79 NEW OXFORD STREET, LONDON, WC1A 1DG, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
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 LIMITED, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, 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 | 22/07/2026 |
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
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.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.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)
Re-crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Milling | |
| 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.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 |
| 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
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 |
| 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) |
| 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-502321, 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 | ||
| ABACAVIR SULPHATE (2000005612) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| DUTASTERIDE (1000007791) | |||
| ROPINIROLE (1000003050) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| LACIDIPINE (1000007375) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| ZANAMIVIR (1000000992) | |||
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 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) |
| 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 | |
| DOLUTEGRAVIR SODIUM (4000014056) | 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 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 |
|
| FLUTICASONE PROPIONATE (2000008220) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| ZIDOVUDINE (1000009208) | APITORIA PHARMA PRIVATE LIMITED, UNIT-II, SURVEY NO. 10 & 13, IDA, KAZIPALLY, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502319, INDIA |
||
| VILANTEROL TRIFENATATE (4000013535) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| LAMIVUDINE (1000003255) | MATRIX PHARMACORP PRIVATE LIMITED (UNIT 2), C/O MATRIX PHARMACORP PRIVATE LIMITED, (UNIT 2), SURVEY NO. 10/42, GADDAPOTHARAM, KAZIPALLY INDUSTRIAL AREA, TELANGANA, SANGAREDDY DISTRICT, IN-502319, INDIA GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
MATRIX PHARMACORP PRIVATE LIMITED (UNIT 2), C/O MATRIX PHARMACORP PRIVATE LIMITED, (UNIT 2), SURVEY NO. 10/42, GADDAPOTHARAM, KAZIPALLY INDUSTRIAL AREA, TELANGANA, SANGAREDDY DISTRICT, IN-502319, INDIA GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
|
| FLUTICASONE FUROATE (2000014516) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| PAZOPANIB (1000011372) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| UMECLIDINIUM BROMIDE (4000014045) | 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 |
||
| DAPRODUSTAT (3000018715) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 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 | ||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| ZIDOVUDINE (1000009208) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| LAMIVUDINE (1000003255) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| PAZOPANIB (1000011372) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| DAPRODUSTAT (3000018715) | |||
| CABOTEGRAVIR SODIUM (2000017021) | |||
| ABACAVIR SULFATE (4000003016) | |||
GLAXO OPERATIONS UK LIMITED, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| FLUTICASONE FUROATE (2000014516) | 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 |
||
| ACICLOVIR (3000006349) | MATRIX PHARMACORP PRIVATE LIMITED (UNIT 2), C/O MATRIX PHARMACORP PRIVATE LIMITED, (UNIT 2), SURVEY NO. 10/42, GADDAPOTHARAM, KAZIPALLY INDUSTRIAL AREA, TELANGANA, SANGAREDDY DISTRICT, IN-502319, INDIA |
||
| HYDROCORTISONE (1000008762) | PHARMACIA & UPJOHN (PFIZER GLOBAL MANUFACTURING), 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
||
| SUMATRIPTAN SUCCINATE (2000008222) | DIVIS LABORATORIES LIMITED, UNIT 2 CHIPPADA VILLAGE, UNIT 2 CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM DISTRICT, ANDHRA PRADESH, IN-531162, INDIA |
||
| 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) | APITORIA PHARMA PRIVATE LIMITED, UNIT-II, SURVEY NO. 10 & 13, IDA, KAZIPALLY, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502319, INDIA |
||
| HYDROUS BENZOYL PEROXIDE (2000007330) | ARKEMA INC., 3289 GENESEE STREET, PIFFARD, 14533, UNITED STATES |
||
| BEPIROVIRSEN (3000020981) | WUXI STA PHARMACEUTICAL CO., LIMITED., 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, JIANGSU, CN-213127, CHINA |
NITTO DENKO AVECIA INC., 125 FORTUNE BOULEVARD, MILFORD, 01757, UNITED STATES |
|
| CABOTEGRAVIR (1000017903) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE N.V.AJINOMOTO OMNICHEM, COOPPALLAAN 91, WETTEREN, B-9230, BELGIUM |
||
| FLUTICASONE PROPIONATE (2000008220) | GLAXOWELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| FLUTICASONE FUROATE (2000014516) | |||
| ZANAMIVIR (1000000992) | |||
| ZIDOVUDINE (1000009208) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||