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)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 17/06/2026 |
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 | |
| 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 |
|
| FLUTICASONE FUROATE (2000014516) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
|
| AMOXICILLIN TRIHYDRATE (4000006303) | CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, BHAI MOHAN SINGH NAGAR, TOANSA, DISTRICT SBS NAGAR (NAWANSHAHR), PUNJAB, IN-144533, 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 |
CENTRIENT PHARMACEUTICALS NETHERLANDS B.V., ALEXANDER FLEMINGLAAN 1, DELFT, NL-2613 AX, NETHERLANDS |
|
| 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 |
|
| 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 |
|
| UMECLIDINIUM BROMIDE (4000014045) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| FLUTICASONE PROPIONATE (2000008220) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
|
| 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 |
|
| 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 |
|
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
||
| FLUMETHASONE (1000002172) | AURISCO PHARMACEUTICAL CO LIMITED, ROOM 1701, HITECH PLAZA, NO 488 S WU NING ROAD, SHANGHAI, CN-200 042, CHINA |
||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
|
| SALMETEROL XINAFOATE (2000008392) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| CABOTEGRAVIR (1000017903) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
||
| PAZOPANIB HYDROCHLORIDE (2000009969) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
|
| 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 |
|
| PARACETAMOL (1000009609) | GRANULES INDIA LIMITED - BONTHAPALLY, H.NO.6-5 & 6-11 TEMPLE ROAD, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, BONTHAPALLY VILLAGE, TELANGANA, IN-502313, INDIA NOVACYL SAS, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA |
||
| VILANTEROL TRIFENATATE (4000013535) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| DAPRODUSTAT (3000018715) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, Data Not Available, 628413, SINGAPORE |
||
| 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 |
||
| 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 |
|
| 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 |
||
| TEBIPENEM (1000023364) | JILIN ASYMCHEM PHARMACEUTICALS CO., LIMITED., NO. 599, XINGQI ROAD, HIGH-TECH INDUSTRIAL ZONE, DUNHUA, JILIN, CN-133700, CHINA |
||
| SOTROVIMAB (1000021589) | WUXI BIOLOGICS CO LIMITED, 108 MEILIANG ROAD, MASHAN BINHU DISTRICT, WUXI, CN-214092, CHINA |
||
| 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 |
||
| LAMIVUDINE (1000003255) | MATRIX PHARMACORP PRIVATE LIMITED, UNIT 8, GAITULA CHODAVARAM, POOSAPATIREGA MANDAL, VIZIANAGARAM, ANDHRA PRADESH, IN-535204, INDIA 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 MATRIX PHARMACORP PRIVATE LIMITED, PLOT NUMBER 1-60/35/A, 6TH TO 9TH FLOOR, HITEC CITY, PHASE II, GACHIBOWLI, HYDERABAD, TELANGANA, IN-500081, INDIA |
|
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | LAURUS LABS LIMITED, UNIT 1 PLOT NO. 21, JAWAHARLAL NEHRU PHARMA CITY, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN 531021, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| SUMATRIPTAN BASE (3000019666) | |||
| CEFUROXIME AXETIL (2000008117) | |||
| FLUTICASONE FUROATE (2000014516) | |||
| CEFEPIME (1000003083) | |||
| CAMLIPIXANT (3000024911) | |||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| MEPOLIZUMAB (1000011081) | |||
| CEFTAZIDIME PENTAHYDRATE (2000008119) | |||
| GEPOTIDACIN MESYLATE (2000017606) | |||
| ZIDOVUDINE (1000009208) | |||
| DEPEMOKIMAB (3000022003) | |||
| AMBRISENTAN (1000000612) | |||
| DOCOSANOL (1000000705) | |||
| UMECLIDINIUM BROMIDE (4000014045) | |||
| ACECLOFENAC (1000003272) | |||
| SALBUTAMOL SULPHATE (2000007742) | |||
| CEPHRADINE MONOHYDRATE (2000017676) | |||
| EPOPROSTENOL SODIUM (2000007668) | |||
| BUSPIRONE HYDROCHLORIDE (2000008275) | |||
| BELANTAMAB (3000020236) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| NIRAPARIB TOSYLATE MONOHYDRATE (2000018219) | |||
| CLINDAMYCIN PHOSPHATE (2000008016) | |||
| FOSTEMSAVIR TROMETHAMINE (2000019620) | |||
| LAMOTRIGINE (1000009498) | |||
| LEVOCETIRIZINE HYDROCHLORIDE (4000007975) | |||
| CEFTRIAXONE SODIUM (2000008050) | |||
| MALEIMIDOCAPROYL MONOMETHYL AURISTATIN F (2000018986) | |||
| DUTASTERIDE (1000007791) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| GRAMICIDIN (1000001561) | |||
| ALBENDAZOLE (1000007408) | |||
| NARATRIPTAN HYDROCHLORIDE (2000007275) | |||
| FRADIOMYCIN SULFATE (4000015498) | |||
| VALACICLOVIR HYDROCHLORIDE (2000007961) | |||
| SALMETEROL XINAFOATE (2000008392) | |||
| NYSTATIN (1000009661) | |||
| POTASSIUM CLAVULANATE (2000007982) | |||
| MUPIROCIN CALCIUM (2000008243) | |||
| ZANAMIVIR (1000000992) | |||
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | |||
| MUPIROCIN FREE ACID (3000018561) | |||
| CABOTEGRAVIR (1000017903) | |||
| ALITRETINOIN (1000000781) | |||
| TRIAMCINOLONE ACETONIDE (2000008586) | |||
| PROGUANIL HYDROCHLORIDE (2000008310) | |||
| NORTRIPTYLINE HYDROCHLORIDE (2000008166) | |||
| SUMATRIPTAN SUCCINATE (2000008222) | |||
| FOSAMPRENAVIR CALCIUM (2000007214) | |||
| PYRIMETHAMINE (1000009747) | |||
| BENZOYL PEROXIDE (1000009105) | |||
| TRAMETINIB (3000016895) | |||
| MOMELOTINIB (1000017840) | |||
| HYDROCORTISONE (1000008762) | |||
| PAZOPANIB HYDROCHLORIDE (2000009969) | |||
| DOLUTEGRAVIR SODIUM (4000014056) | |||
| BEPIROVIRSEN (3000020981) | |||
| BACITRACIN ZINC (2000008439) | |||
| CISATRACURIUM BESYLATE (2000007625) | |||
| ATOVAQUONE (1000007298) | |||
| PAROXETINE HYDROCHLORIDE (2000008319) | |||
| PARACETAMOL (1000009609) | |||
| RILPIVIRINE HYDROCHLORIDE (2000016484) | |||
| VILANTEROL TRIFENATATE (4000013535) | |||
| CEFADROXIL MONOHYDRATE (2000008181) | |||
| LAPATINIB DITOSYLATE (2000009158) | |||
| CAPTOPRIL (1000006787) | |||
| CEFUROXIME SODIUM (2000008116) | |||
| TOPOTECAN HYDROCHLORIDE (2000007090) | |||
| DAPRODUSTAT (3000018715) | |||
| ABACAVIR SULPHATE (2000005612) | |||
| ROPINIROLE HYDROCHLORIDE (2000008566) | |||
| NEOMYCIN SULFATE (4000014380) | |||
| REMIFENTANIL HYDROCHLORIDE (2000007435) | |||
| ACYCLOVIR (1000007387) | |||
| BELIMUMAB (1000011881) | |||
| BELANTAMAB MAFODOTIN (3000020293) | |||
| CLOBETASONE BUTYRATE (2000008013) | |||
| TEBIPENEM (1000023364) | |||
| SOTROVIMAB (1000021589) | |||
| TRANYLCYPROMINE SULPHATE (2000008589) | |||
| LACIDIPINE (1000007375) | |||
| BECLOMETHASONE DIPROPIONATE (2000008376) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| LAMIVUDINE (1000003255) | |||
| TENOFOVIR DISOPROXIL FUMARATE (2000005915) | |||