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 | 22/04/2025 |
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 | |
| 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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| 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 |
|
| 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 |
AUROBINDO PHARMA LIMITED - MAITRIVIHAR, PLOT NO.2, MAITRIVIHAR, AMEERPET, HYDERABAD, TELANGANA, IN-500 038, INDIA |
|
| FLUTICASONE FUROATE (2000014516) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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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 |
TEVA API B.V, PIET HEINKADE 107, AMSTERDAM, NL-1019 GM, NETHERLANDS |
|
| TRIPROLIDINE HYDROCHLORIDE (2000008490) | 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 |
|
| CABOTEGRAVIR (1000017903) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| 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 |
|
| PARACETAMOL (1000009609) | 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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| FLUTICASONE PROPIONATE (2000008220) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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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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| SOTROVIMAB (1000021589) | WUXI BIOLOGICS CO LIMITED, 108 MEILIANG ROAD, MASHAN BINHU DISTRICT, WUXI, CN-214092, CHINA |
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| PAZOPANIB HYDROCHLORIDE (2000009969) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| 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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| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | LAURUS LABS LIMITED, PLOT NO. 21, JAWAHARLAL NEHRU PHARMA CITY, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN 531021, INDIA |
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| DOLUTEGRAVIR SODIUM (4000014056) | SHIONOGI & CO. LIMITED, 224-20, HIRAISHIEBISUNO, KAWAUCHI-CHO, TOKUSHIMA, JP 771-0132, JAPAN 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 |
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| MUPIROCIN CALCIUM (2000008243) | CONCORD BIOTECH LIMITED - TRASAD ROAD, 1482-1486 TRASAD ROAD, DHOLKA, AHMEDABAD DISTRICT, GUJARAT, IN-382 225, INDIA |
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| 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 |
|
| TRAMETINIB (3000016895) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| ONDANSETRON HYDROCHLORIDE (2000008385) | 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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| AMOXICILLIN TRIHYDRATE (4000006303) | CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, BHAI MOHAN SINGH NAGAR, TOANSA, NAWANSHAHR, PUNJAB, IN-144 533, INDIA 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 |
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| LAMIVUDINE (1000003255) | 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 TIANISH LABORATORIES PRIVATE LIMITED, UNIT 8, GAITULA CHODAVARAM, POOSAPATIREGA MANDAL, VIZIANAGARAM DISTRICT, ANDHRA PRADESH, 535204, INDIA |
||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LIMITED., 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 |
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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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| 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 |
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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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| DAPRODUSTAT (3000018715) | 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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| ACYCLOVIR (1000007387) | ZHEJIANG CHARIOTEER PHARMACEUTICAL, TONGYUANXI, DAZHAN, XIANJU, ZHEJIANG PROVINCE, CN-317 321, CHINA TIANISH LABORATORIES PRIVATE LIMITED, UNIT 2, SURVEY NUMBERS 10 AND 42, GADDAPOTHARAM, KHAZIPALLI INDUSTRIAL AREA, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502319, INDIA |
MYLAN LABORATORIES LIMITED, PLOT NO. 564/A/22, ROAD NO. 92, JUBILEE HILLS, HYDERABAD, TELANGANA, IN-500096, INDIA TIANISH LABORATORIES PRIVATE LIMITED, PLOT NO.564/A/22 ROAD NO.92, JUBILEE HILLS, FILM NAGAR, SHAIKPET, HYDERABAD, IN-50096, INDIA |
|
| UMECLIDINIUM BROMIDE (4000014045) | 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 |
|
| LINERIXIBAT (1000020770) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO. LTD., NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CLOBETASONE BUTYRATE (2000008013) | |||
| NORTRIPTYLINE HYDROCHLORIDE (2000008166) | |||
| VALACICLOVIR HYDROCHLORIDE (2000007961) | |||
| NEOMYCIN SULFATE (4000014380) | |||
| TAMSULOSIN HYDROCHLORIDE (2000007876) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| ZIDOVUDINE (1000009208) | |||
| GRAMICIDIN (1000001561) | |||
| BELANTAMAB (3000020236) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| LACIDIPINE (1000007375) | |||
| DOCOSANOL (1000000705) | |||
| ACECLOFENAC (1000003272) | |||
| TRIPROLIDINE HYDROCHLORIDE (2000008490) | |||
| CEFADROXIL MONOHYDRATE (2000008181) | |||
| CABOTEGRAVIR (1000017903) | |||
| LAMOTRIGINE (1000009498) | |||
| POTASSIUM CLAVULANATE (2000007982) | |||
| ALITRETINOIN (1000000781) | |||
| PARACETAMOL (1000009609) | |||
| CEFEPIME (1000003083) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| FOSAMPRENAVIR CALCIUM (2000007214) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| POLYMYXIN B SULPHATE (4000010173) | |||
| AMBRISENTAN (1000000612) | |||
| FLUPHENAZINE HYDROCHLORIDE (2000007501) | |||
| TRANYLCYPROMINE SULPHATE (2000008589) | |||
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | |||
| SOTROVIMAB (1000021589) | |||
| MOMELOTINIB (1000017840) | |||
| PYRIMETHAMINE (1000009747) | |||
| PAZOPANIB HYDROCHLORIDE (2000009969) | |||
| ZANAMIVIR (1000000992) | |||
| CLIOQUINOL (1000004182) | |||
| TOPOTECAN HYDROCHLORIDE (2000007090) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| HYDROCORTISONE (1000008762) | |||
| OTILIMAB (3000020232) | |||
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | |||
| CEFUROXIME SODIUM (2000008116) | |||
| CEFUROXIME AXETIL (2000008117) | |||
| FOSTEMSAVIR TROMETHAMINE (2000019620) | |||
| BUSPIRONE HYDROCHLORIDE (2000008275) | |||
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| ATRACURIUM BESYLATE (2000008448) | |||
| CISATRACURIUM BESYLATE (2000007625) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| MUPIROCIN CALCIUM (2000008243) | |||
| SUMATRIPTAN SUCCINATE (2000008222) | |||
| CAPTOPRIL (1000006787) | |||
| TRAMETINIB (3000016895) | |||
| PROGUANIL HYDROCHLORIDE (2000008310) | |||
| GEPOTIDACIN (1000018585) | |||
| ONDANSETRON HYDROCHLORIDE (2000008385) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| MEPOLIZUMAB (1000011081) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| ROPINIROLE HYDROCHLORIDE (2000008566) | |||
| LEVOCETIRIZINE HYDROCHLORIDE (4000007975) | |||
| BELANTAMAB MAFODOTIN (3000020293) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| LAMIVUDINE (1000003255) | |||
| CEFTAZIDIME PENTAHYDRATE (2000008119) | |||
| DUTASTERIDE (1000007791) | |||
| CEPHRADINE MONOHYDRATE (2000017676) | |||
| BELIMUMAB (1000011881) | |||
| REMIFENTANIL HYDROCHLORIDE (2000007435) | |||
| ATOVAQUONE (1000007298) | |||
| BACITRACIN ZINC (2000008439) | |||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | |||
| MELPHALAN (1000001442) | |||
| CEPHALEXIN MONOHYDRATE (4000009451) | |||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | |||
| BENZOYL PEROXIDE (1000009105) | |||
| SUMATRIPTAN BASE (3000019666) | |||
| NYSTATIN (1000009661) | |||
| CEFTRIAXONE SODIUM (2000008050) | |||
| ALBENDAZOLE (1000007408) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| FRADIOMYCIN SULFATE (4000015498) | |||
| MUPIROCIN FREE ACID (3000018561) | |||
| EPOPROSTENOL SODIUM (2000007668) | |||
| DAPRODUSTAT (3000018715) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| PAROXETINE HYDROCHLORIDE (2000008319) | |||
| ACYCLOVIR (1000007387) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| CLINDAMYCIN PHOSPHATE (2000008016) | |||
| BECLOMETHASONE DIPROPIONATE (2000008376) | |||
| ALLOPURINOL (1000003843) | |||
| LINERIXIBAT (1000020770) | |||