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 | 16/10/2024 |
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
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 | |
| 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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| SUMATRIPTAN SUCCINATE (2000008222) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE 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 |
|
| 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 PROPIONATE (2000008220) | 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 |
|
| 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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| PAZOPANIB HYDROCHLORIDE (2000009969) | 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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| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| DABRAFENIB MESYLATE (2000017501) | 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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| UMECLIDINIUM BROMIDE (4000014045) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| TRAMETINIB (3000016895) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| DOLUTEGRAVIR SODIUM (4000014056) | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LIMITED., 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA 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 |
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| LAMIVUDINE (1000003255) | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LIMITED., 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA MYLAN LABORATORIES LIMITED, UNIT 2, SURVEY NO. 10/42, KAZIPALLY INDUSTRIAL AREA, SANGAREDDY DISTRICT, GADDAPOTHARAM, TELANGANA, IN-502319, INDIA 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 MYLAN LABORATORIES LIMITED - PATANCHERU, (UNIT 7), PLOT NO. 14, 99 & 100, I.D.A, PASHAMYLARAM PHASE II, Data Not Available, PATANCHERU,TELANGANA, IN-502 307, INDIA |
MYLAN LABORATORIES LIMITED, PLOT NO. 564/A/22, ROAD NO. 92, JUBILEE HILLS, HYDERABAD, TELANGANA, IN-500096, INDIA |
|
| 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 |
|
| 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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| AMOXICILLIN TRIHYDRATE (4000006303) | CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, BHAI MOHAN SINGH NAGAR, TOANSA, NAWANSHAHR, PUNJAB, IN-144 533, INDIA BEECHAMS PHARMACEUTICALS, 38 QUALITY ROAD, JURONG INDUSTRIAL ESTATE, Data Not Available, SGP- 618 809, 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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| 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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| 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 |
|
| 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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| 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 |
|
| MUPIROCIN CALCIUM (2000008243) | CONCORD BIOTECH LIMITED - TRASAD ROAD, 1482-1486 TRASAD ROAD, DHOLKA, AHMEDABAD DISTRICT, GUJARAT, IN-382 225, 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 |
|
| NARATRIPTAN HYDROCHLORIDE (2000007275) | 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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| VILANTEROL TRIFENATATE (4000013535) | 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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| FLUTICASONE FUROATE (2000014516) | 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 |
|
| DAPRODUSTAT (3000018715) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| FOSAMPRENAVIR CALCIUM (2000007214) | |||
| EPOPROSTENOL SODIUM (2000007668) | |||
| NEOMYCIN SULFATE (4000014380) | |||
| PARACETAMOL (1000009609) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| SUMATRIPTAN SUCCINATE (2000008222) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| BELANTAMAB MAFODOTIN (3000020293) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| LAMOTRIGINE (1000009498) | |||
| SUMATRIPTAN BASE (3000019666) | |||
| POTASSIUM CLAVULANATE (2000007982) | |||
| ALBENDAZOLE (1000007408) | |||
| HYDROCORTISONE (1000008762) | |||
| PAZOPANIB HYDROCHLORIDE (2000009969) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| CISATRACURIUM BESYLATE (2000007625) | |||
| ELTROMBOPAG OLAMINE (2000018050) | |||
| SOTROVIMAB (1000021589) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | |||
| ROPINIROLE HYDROCHLORIDE (2000008566) | |||
| BACITRACIN ZINC (2000008439) | |||
| PROGUANIL HYDROCHLORIDE (2000008310) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| DUTASTERIDE (1000007791) | |||
| DABRAFENIB MESYLATE (2000017501) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| ALLOPURINOL (1000003843) | |||
| TRANYLCYPROMINE SULPHATE (2000008589) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| BELANTAMAB (3000020236) | |||
| BENZOYL PEROXIDE (1000009105) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| TRAMETINIB (3000016895) | |||
| TAMSULOSIN HYDROCHLORIDE (2000007876) | |||
| PAROXETINE HYDROCHLORIDE (2000008319) | |||
| BUSPIRONE HYDROCHLORIDE (2000008275) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| GRAMICIDIN (1000001561) | |||
| LACIDIPINE (1000007375) | |||
| LAMIVUDINE (1000003255) | |||
| ACYCLOVIR (1000007387) | |||
| CEFEPIME (1000003083) | |||
| PROPAFENONE HYDROCHLORIDE (2000008317) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| AMBRISENTAN (1000000612) | |||
| CEFUROXIME SODIUM (2000008116) | |||
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | |||
| TRIPROLIDINE HYDROCHLORIDE (2000008490) | |||
| CEFUROXIME AXETIL (2000008117) | |||
| ACECLOFENAC (1000003272) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| CEFADROXIL MONOHYDRATE (2000008181) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| CEPHALEXIN MONOHYDRATE (4000009451) | |||
| POLYMYXIN B SULPHATE (4000010173) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| CEFTRIAXONE SODIUM (2000008050) | |||
| TOPOTECAN HYDROCHLORIDE (2000007090) | |||
| CAPTOPRIL (1000006787) | |||
| AZATHIOPRINE (1000009761) | |||
| FOSTEMSAVIR TROMETHAMINE (2000019620) | |||
| EPTIFIBATIDE (1000008350) | |||
| CEPHRADINE MONOHYDRATE (2000017676) | |||
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | |||
| FRADIOMYCIN SULFATE (4000015498) | |||
| NYSTATIN (1000009661) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| ZANAMIVIR (1000000992) | |||
| CLINDAMYCIN PHOSPHATE (2000008016) | |||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | |||
| DOCOSANOL (1000000705) | |||
| GEPOTIDACIN (1000018585) | |||
| REMIFENTANIL HYDROCHLORIDE (2000007435) | |||
| ATRACURIUM BESYLATE (2000008448) | |||
| MUPIROCIN CALCIUM (2000008243) | |||
| MOMELOTINIB (1000017840) | |||
| VALACICLOVIR HYDROCHLORIDE (2000007961) | |||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | |||
| ONDANSETRON HYDROCHLORIDE (2000008385) | |||
| MEPOLIZUMAB (1000011081) | |||
| LEVOCETIRIZINE HYDROCHLORIDE (4000007975) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| OFATUMUMAB (1000011488) | |||
| BELIMUMAB (1000011881) | |||
| ALITRETINOIN (1000000781) | |||
| MUPIROCIN FREE ACID (3000018561) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| LABETALOL HYDROCHLORIDE (2000008520) | |||
| CABOTEGRAVIR (1000017903) | |||
| PYRIMETHAMINE (1000009747) | |||
| MELPHALAN (1000001442) | |||
| NORTRIPTYLINE HYDROCHLORIDE (2000008166) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| CEFTAZIDIME PENTAHYDRATE (2000008119) | |||
| BECLOMETHASONE DIPROPIONATE (2000008376) | |||
| CLIOQUINOL (1000004182) | |||
| CARVEDILOL PHOSPHATE (2000017675) | |||
| ZIDOVUDINE (1000009208) | |||
| ATOVAQUONE (1000007298) | |||
| OTILIMAB (3000020232) | |||
| DAPRODUSTAT (3000018715) | |||
| FLUPHENAZINE HYDROCHLORIDE (2000007501) | |||