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 42657 |
| 2. Name or corporate name of registrant | GLAXOSMITHKLINE TRADING SERVICES LIMITED |
| 3. Permanent or legal address of registrant | GLAXOSMITHKLINE TRADING SERVICES LIMITED, 79 NEW OXFORD STREET, LONDON, WC1A 1DG, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
GLAXOSMITHKLINE TRADING SERVICES LIMITED, 79 NEW OXFORD STREET, LONDON, WC1A 1DG, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 13/08/2026 |
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 TRADING SERVICES LIMITED, 79 NEW OXFORD STREET, LONDON, WC1A 1DG, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| ABACAVIR SULPHATE (2000005612) | PIRAMAL PHARMA LIMITED, SURVEY NOS.7-70, 70/1 AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502321, INDIA |
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| SUMATRIPTAN BASE (3000019666) | DIVIS LABORATORIES LIMITED (UNIT 2) VISAKHAPATNAM DISTRICT, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
DIVIS LABORATORIES LIMITED - CYBER HILLS, 1-72/23 (P)/DIVIS/303, DIVI TOWERS, CYBER HILLS, GACHIBOWLI, HYDERABAD, IN-500032, INDIA |
|
| LAMOTRIGINE (1000009498) | DIVIS LABORATORIES LIMITED (UNIT 2) VISAKHAPATNAM DISTRICT, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
DIVIS LABORATORIES LIMITED - CYBER HILLS, 1-72/23 (P)/DIVIS/303, DIVI TOWERS, CYBER HILLS, GACHIBOWLI, HYDERABAD, IN-500032, INDIA |
|
| SOTROVIMAB (1000021589) | WUXI BIOLOGICS CO LIMITED, 108 MEILIANG ROAD, MASHAN BINHU DISTRICT, WUXI, CN-214092, CHINA |
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| BEPIROVIRSEN (3000020981) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LTD., NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA |
STA PHARMACEUTICAL HONG KONG LTD, 9 YUEGONG ROAD, JINSHAN DISTRICT, SHANGHAI, CN-201507, CHINA |
|
| SUMATRIPTAN SUCCINATE (2000008222) | DIVIS LABORATORIES LIMITED (UNIT 2) VISAKHAPATNAM DISTRICT, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
DIVIS LABORATORIES LIMITED - CYBER HILLS, 1-72/23 (P)/DIVIS/303, DIVI TOWERS, CYBER HILLS, GACHIBOWLI, HYDERABAD, IN-500032, INDIA |
|
| UMECLIDINIUM BROMIDE (4000014045) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| CLOBETASONE BUTYRATE (2000008013) | SYMBIOTEC PHARMALAB PVT LIMITED, PLOT NO. 385/2 PIGDAMBER, NEAR HOTEL MASHAL, OFF A B ROAD, RAU, INDORE DISTRICT, MADHYA PRADESH, IN-453331, INDIA |
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| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| SALMETEROL XINAFOATE (2000008392) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| CLOBETASOL PROPIONATE (2000008014) | SYMBIOTEC PHARMALAB PVT LIMITED, PLOT NO. 385/2 PIGDAMBER, NEAR HOTEL MASHAL, OFF A B ROAD, RAU, INDORE DISTRICT, MADHYA PRADESH, IN-453331, INDIA |
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| FLUTICASONE FUROATE (2000014516) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| CABOTEGRAVIR (1000017903) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| PARACETAMOL (1000009609) | NOVACYL SAS, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA GRANULES INDIA LIMITED - BONTHAPALLY, H.NO.6-5 & 6-11 TEMPLE ROAD, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, BONTHAPALLY VILLAGE, TELANGANA, IN-502313, INDIA |
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| LAMIVUDINE (1000003255) | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LIMITED., 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA MATRIX PHARMACORP PRIVATE LIMITED, UNIT 8, GAITULA CHODAVARAM, POOSAPATIREGA MANDAL, VIZIANAGARAM, ANDHRA PRADESH, IN-535204, INDIA |
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL COMPANY LIMITED, 1479 ZHANGHENG ROAD, ZHANGJIANG HI-TECH PARK, SHANGHAI, CN 201203, CHINA MATRIX PHARMACORP PRIVATE LIMITED, PLOT NUMBER 1-60/35/A, 6TH TO 9TH FLOOR, HITEC CITY, PHASE II, GACHIBOWLI, HYDERABAD, TELANGANA, IN-500081, INDIA |
|
| TRAMETINIB (3000016895) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| ALBENDAZOLE (1000007408) | UQUIFA MEXICO S.A. DE C.V., CALLE 37 ESTE NO 126, INDUSTRIAL DEL VALLE DE CUERNAVACA (CIVAC), JIUTEPEC, MORELOS, MX-62578, MEXICO |
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| DOLUTEGRAVIR SODIUM (4000014056) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LIMITED., 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA |
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL COMPANY LIMITED, 1479 ZHANGHENG ROAD, ZHANGJIANG HI-TECH PARK, SHANGHAI, CN 201203, CHINA |
|
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LTD., NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
STA PHARMACEUTICAL HONG KONG LTD, 9 YUEGONG ROAD, JINSHAN DISTRICT, SHANGHAI, CN-201507, CHINA |
|
| DAPRODUSTAT (3000018715) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| ACYCLOVIR (1000007387) | MATRIX PHARMACORP PRIVATE LIMITED, (UNIT 2) SURVEY NO.10/ AND KAZIPALLY INDUSTRIAL AREA, GADDAPOTHARAM, TELEGANA, IN-502319, INDIA ZHEJIANG CHARIOTEER PHARMACEUTICAL, TONGYUANXI, DAZHAN, XIANJU, ZHEJIANG PROVINCE, CN-317 321, CHINA |
MATRIX PHARMACORP PRIVATE LIMITED, PLOT NUMBER 1-60/35/A, 6TH TO 9TH FLOOR, HITEC CITY, PHASE II, GACHIBOWLI, HYDERABAD, TELANGANA, IN-500081, INDIA MYLAN LABORATORIES LIMITED, PLOT NO. 564/A/22, ROAD NO. 92, JUBILEE HILLS, HYDERABAD, TELANGANA, IN-500096, INDIA |
|
| AMOXICILLIN TRIHYDRATE (4000006303) | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LIMITED, ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, FIRST MEDICAL ZONE, DATONG, SHANXI PROVINCE, CN-037700, CHINA BEECHAMS PHARMACEUTICALS, 38 QUALITY ROAD, JURONG INDUSTRIAL ESTATE, Data Not Available, SGP- 618 809, SINGAPORE CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, BHAI MOHAN SINGH NAGAR, TOANSA, DISTRICT SBS NAGAR (NAWANSHAHR), PUNJAB, IN-144533, INDIA |
CENTRIENT PHARMACEUTICALS NETHERLANDS B.V., ALEXANDER FLEMINGLAAN 1, DELFT, NL-2613 AX, NETHERLANDS |
|
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | LAURUS LABS LIMITED, UNIT 1 PLOT NO. 21, JAWAHARLAL NEHRU PHARMA CITY, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN 531021, INDIA |
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| VALACICLOVIR HYDROCHLORIDE (2000007961) | DIVI'S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
DIVIS LABORATORIES LIMITED - CYBER HILLS, 1-72/23 (P)/DIVIS/303, DIVI TOWERS, CYBER HILLS, GACHIBOWLI, HYDERABAD, IN-500032, INDIA |
|
| PAZOPANIB HYDROCHLORIDE (2000009969) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| NARATRIPTAN HYDROCHLORIDE (2000007275) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| CLINDAMYCIN PHOSPHATE (2000008016) | ZHEJIANG HISOAR CHUANNAN PHARMACEATICAL CO. LIMITED, NO.23, 5TH DONGHAI AVENUE, ZHEJIANG CHEMICAL MATERIALS BASE LINHAI ZONE, LINHAI, TAIZHOU, ZHEJIANG PROVINCE, CN 317016, CHINA |
ZHEJIANG HISOAR PHARMACEATICAL CO, NO 100 WAISHA BRANCH ROAD, JIAOJIANG, TAIZHOU, ZHEJIANG PROVINCE, CN-318000, CHINA |
|
| FLUMETHASONE (1000002172) | AURISCO PHARMACEUTICAL CO LIMITED, ROOM 1701, HITECH PLAZA, NO 488 S WU NING ROAD, SHANGHAI, CN-200 042, CHINA |
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| CAMLIPIXANT (3000024911) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LTD., NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA TAIXING SYNTHEALL PHARMACEUTICAL CO., LIMITED., 18 TIANXING ROAD, ECONOMIC DEVELOPMENT ZONE, TAIXING, JIANGSU, CN-225442, CHINA |
STA PHARMACEUTICAL HONG KONG LTD, 9 YUEGONG ROAD, JINSHAN DISTRICT, SHANGHAI, CN-201507, CHINA |
|
| VILANTEROL TRIFENATATE (4000013535) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| ZIDOVUDINE (1000009208) | APITORIA PHARMA PRIVATE LIMITED, UNIT-II, SURVEY NO. 10 & 13, IDA, KAZIPALLY, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502319, INDIA |
APITORIA PHARMA PRIVATE LIMITED, FLOORS 22-24, PLOT NO. 1, SURVEY NO. 83/1, GALAXY TOWER, HYDERABAD KNOWLEDGE CITY, RAIDURG PANMAKTHA, HYDERABAD, TELANGANA, IN-500032, INDIA |
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| TEBIPENEM (1000023364) | JILIN ASYMCHEM PHARMACEUTICALS CO., LIMITED., NO. 599, XINGQI ROAD, HIGH-TECH INDUSTRIAL ZONE, DUNHUA, JILIN, CN-133700, CHINA |
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| DOCOSANOL (1000000705) | TEVA API INDIA PRIVATE LIMITED, PLOT NO A-2 , A-2/1, A-2/2 UPSIDC INDUSTRIAL AREA, BIJNOR ROAD, AMROHA, GAJRAULA, UTTAR PRADESH, IN-244 235, INDIA |
TAPI NL B.V., PIET HEINKADE 55, AMSTERDAM, 1019GM, NETHERLANDS |
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| FLUTICASONE PROPIONATE (2000008220) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| LINERIXIBAT (1000020770) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LTD., NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA |
STA PHARMACEUTICAL HONG KONG LTD, 9 YUEGONG ROAD, JINSHAN DISTRICT, SHANGHAI, CN-201507, CHINA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| SALBUTAMOL SULPHATE (2000007742) | |||
| CEFEPIME (1000003083) | |||
| HYDROCORTISONE (1000008762) | |||
| BACITRACIN ZINC (2000008439) | |||
| ROPINIROLE HYDROCHLORIDE (2000008566) | |||
| TOPOTECAN HYDROCHLORIDE (2000007090) | |||
| FOSAMPRENAVIR CALCIUM (2000007214) | |||
| PYRIMETHAMINE (1000009747) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| AMBRISENTAN (1000000612) | |||
| GRAMICIDIN (1000001561) | |||
| PAROXETINE HYDROCHLORIDE (2000008319) | |||
| CEFUROXIME AXETIL (2000008117) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| SUMATRIPTAN BASE (3000019666) | |||
| DEPEMOKIMAB (3000022003) | |||
| BUSPIRONE HYDROCHLORIDE (2000008275) | |||
| CEFTAZIDIME PENTAHYDRATE (2000008119) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| LAMOTRIGINE (1000009498) | |||
| CAPTOPRIL (1000006787) | |||
| SOTROVIMAB (1000021589) | |||
| BEPIROVIRSEN (3000020981) | |||
| SUMATRIPTAN SUCCINATE (2000008222) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| POTASSIUM CLAVULANATE (2000007982) | |||
| NORTRIPTYLINE HYDROCHLORIDE (2000008166) | |||
| ACECLOFENAC (1000003272) | |||
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| MUPIROCIN CALCIUM (2000008243) | |||
| BELANTAMAB MAFODOTIN (3000020293) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| NEOMYCIN SULFATE (4000014380) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| CABOTEGRAVIR (1000017903) | |||
| REMIFENTANIL HYDROCHLORIDE (2000007435) | |||
| DUTASTERIDE (1000007791) | |||
| PARACETAMOL (1000009609) | |||
| LAMIVUDINE (1000003255) | |||
| TRAMETINIB (3000016895) | |||
| PROGUANIL HYDROCHLORIDE (2000008310) | |||
| ALBENDAZOLE (1000007408) | |||
| CEFUROXIME SODIUM (2000008116) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | |||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | |||
| DAPRODUSTAT (3000018715) | |||
| NYSTATIN (1000009661) | |||
| ACYCLOVIR (1000007387) | |||
| LACIDIPINE (1000007375) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| MEPOLIZUMAB (1000011081) | |||
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | |||
| BENZOYL PEROXIDE (1000009105) | |||
| CEFTRIAXONE SODIUM (2000008050) | |||
| BELIMUMAB (1000011881) | |||
| EPOPROSTENOL SODIUM (2000007668) | |||
| VALACICLOVIR HYDROCHLORIDE (2000007961) | |||
| BELANTAMAB (3000020236) | |||
| PAZOPANIB HYDROCHLORIDE (2000009969) | |||
| BECLOMETHASONE DIPROPIONATE (2000008376) | |||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | |||
| CLINDAMYCIN PHOSPHATE (2000008016) | |||
| GEPOTIDACIN MESYLATE (2000017606) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| CEFADROXIL MONOHYDRATE (2000008181) | |||
| CAMLIPIXANT (3000024911) | |||
| MOMELOTINIB (1000017840) | |||
| LEVOCETIRIZINE HYDROCHLORIDE (4000007975) | |||
| CEPHRADINE MONOHYDRATE (2000017676) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| ALITRETINOIN (1000000781) | |||
| ZIDOVUDINE (1000009208) | |||
| ZANAMIVIR (1000000992) | |||
| FRADIOMYCIN SULFATE (4000015498) | |||
| CISATRACURIUM BESYLATE (2000007625) | |||
| ATOVAQUONE (1000007298) | |||
| TEBIPENEM (1000023364) | |||
| DOCOSANOL (1000000705) | |||
| MUPIROCIN FREE ACID (3000018561) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| FOSTEMSAVIR TROMETHAMINE (2000019620) | |||
| TRANYLCYPROMINE SULPHATE (2000008589) | |||
| LINERIXIBAT (1000020770) | |||