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, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
GLAXOSMITHKLINE TRADING SERVICES LIMITED, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, 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 | 16/04/2024 |
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, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| MUPIROCIN FREE ACID (3000018561) | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LIMITED, NO.7278, MEILIN AVENUE, DAJIANGDONG INDUSTRIAL CLUSTER ZONE, HANGZHOU, ZHEJIANG, CN-310011, CHINA |
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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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| DABRAFENIB MESYLATE (2000017501) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| VALACICLOVIR HYDROCHLORIDE (2000007961) | DIVIS LABORATORIES LIMITED - LINGOJIGUDEM VILLAGE, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508 252, 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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| 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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| MUPIROCIN CALCIUM (2000008243) | CONCORD BIOTECH LIMITED - TRASAD ROAD, 1482-1486 TRASAD ROAD, DHOLKA, AHMEDABAD DISTRICT, GUJARAT, IN-382 225, INDIA |
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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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| 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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| 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 |
|
| 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 |
|
| ACYCLOVIR (1000007387) | 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 ZHEJIANG CHARIOTEER PHARMACEUTICAL, TONGYUANXI, DAZHAN, XIANJU, ZHEJIANG PROVINCE, CN-317 321, CHINA |
MYLAN LABORATORIES LIMITED, PLOT NO. 564/A/22, ROAD NO. 92, JUBILEE HILLS, HYDERABAD, TELANGANA, IN-500096, INDIA |
|
| AMOXICILLIN TRIHYDRATE (4000006303) | 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, NAWANSHAHR, PUNJAB, IN-144 533, INDIA |
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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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| 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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| 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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| FLUTICASONE PROPIONATE (2000008220) | 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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| DOLUTEGRAVIR SODIUM (4000014056) | SHIONOGI & CO. LIMITED, 224-20, HIRAISHIEBISUNO, KAWAUCHI-CHO, TOKUSHIMA, JP 771-0132, JAPAN SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LIMITED., 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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| DUTASTERIDE (1000007791) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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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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| 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 |
|
| CABOTEGRAVIR (1000017903) | 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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| 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 |
|
| 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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| 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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| VILANTEROL TRIFENATATE (4000013535) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
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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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| 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 |
|
| ONDANSETRON HYDROCHLORIDE (2000008385) | 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 GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE MYLAN LABORATORIES LIMITED, UNIT 2, SURVEY NO. 10/42, KAZIPALLY INDUSTRIAL AREA, SANGAREDDY DISTRICT, GADDAPOTHARAM, TELANGANA, IN-502319, 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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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| NYSTATIN (1000009661) | |||
| MUPIROCIN FREE ACID (3000018561) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| ATOVAQUONE (1000007298) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| DABRAFENIB MESYLATE (2000017501) | |||
| ALLOPURINOL (1000003843) | |||
| VALACICLOVIR HYDROCHLORIDE (2000007961) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| BELANTAMAB (3000020236) | |||
| SUMATRIPTAN BASE (3000019666) | |||
| NEOMYCIN SULFATE (4000014380) | |||
| SOTROVIMAB (1000021589) | |||
| AMBRISENTAN (1000000612) | |||
| LACIDIPINE (1000007375) | |||
| PAZOPANIB HYDROCHLORIDE (2000009969) | |||
| MUPIROCIN CALCIUM (2000008243) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| FOSAMPRENAVIR CALCIUM (2000007214) | |||
| GEPOTIDACIN (1000018585) | |||
| TRAMETINIB (3000016895) | |||
| NORTRIPTYLINE HYDROCHLORIDE (2000008166) | |||
| PARACETAMOL (1000009609) | |||
| DOCOSANOL (1000000705) | |||
| AZATHIOPRINE (1000009761) | |||
| CEFEPIME (1000003083) | |||
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | |||
| CAPTOPRIL (1000006787) | |||
| CEFTRIAXONE SODIUM (2000008050) | |||
| CLINDAMYCIN PHOSPHATE (2000008016) | |||
| ACYCLOVIR (1000007387) | |||
| POLYMYXIN B SULPHATE (4000010173) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| MEPOLIZUMAB (1000011081) | |||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | |||
| CLIOQUINOL (1000004182) | |||
| FLUPHENAZINE HYDROCHLORIDE (2000007501) | |||
| ROPINIROLE HYDROCHLORIDE (2000008566) | |||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | |||
| ATRACURIUM BESYLATE (2000008448) | |||
| LABETALOL HYDROCHLORIDE (2000008520) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| ELTROMBOPAG OLAMINE (2000018050) | |||
| FRADIOMYCIN SULFATE (4000015498) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| CEFUROXIME AXETIL (2000008117) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| MELPHALAN (1000001442) | |||
| TRANYLCYPROMINE SULPHATE (2000008589) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| GRAMICIDIN (1000001561) | |||
| CEFTAZIDIME PENTAHYDRATE (2000008119) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| TOPOTECAN HYDROCHLORIDE (2000007090) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| OFATUMUMAB (1000011488) | |||
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | |||
| DUTASTERIDE (1000007791) | |||
| BACITRACIN ZINC (2000008439) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| CEPHALEXIN MONOHYDRATE (4000009451) | |||
| TAMSULOSIN HYDROCHLORIDE (2000007876) | |||
| PROPAFENONE HYDROCHLORIDE (2000008317) | |||
| HYDROCORTISONE (1000008762) | |||
| SUMATRIPTAN SUCCINATE (2000008222) | |||
| CABOTEGRAVIR (1000017903) | |||
| PYRIMETHAMINE (1000009747) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| LAMOTRIGINE (1000009498) | |||
| MOMELOTINIB (1000017840) | |||
| ALBENDAZOLE (1000007408) | |||
| EPTIFIBATIDE (1000008350) | |||
| LEVOCETIRIZINE HYDROCHLORIDE (4000007975) | |||
| EPOPROSTENOL SODIUM (2000007668) | |||
| BECLOMETHASONE DIPROPIONATE (2000008376) | |||
| CEPHRADINE MONOHYDRATE (2000017676) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| PROGUANIL HYDROCHLORIDE (2000008310) | |||
| TRIPROLIDINE HYDROCHLORIDE (2000008490) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| BUSPIRONE HYDROCHLORIDE (2000008275) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| PAROXETINE HYDROCHLORIDE (2000008319) | |||
| BELANTAMAB MAFODOTIN (3000020293) | |||
| OTILIMAB (3000020232) | |||
| ZANAMIVIR (1000000992) | |||
| DAPRODUSTAT (3000018715) | |||
| ZIDOVUDINE (1000009208) | |||
| FOSTEMSAVIR TROMETHAMINE (2000019620) | |||
| BENZOYL PEROXIDE (1000009105) | |||
| CEFADROXIL MONOHYDRATE (2000008181) | |||
| ONDANSETRON HYDROCHLORIDE (2000008385) | |||
| CISATRACURIUM BESYLATE (2000007625) | |||
| POTASSIUM CLAVULANATE (2000007982) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| LAMIVUDINE (1000003255) | |||
| CARVEDILOL PHOSPHATE (2000017675) | |||
| REMIFENTANIL HYDROCHLORIDE (2000007435) | |||
| ACECLOFENAC (1000003272) | |||
| CEFUROXIME SODIUM (2000008116) | |||
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | |||
| BELIMUMAB (1000011881) | |||
| ALITRETINOIN (1000000781) | |||