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 39541 |
| 2. Name or corporate name of registrant | ASCOT LABORATORIES LIMITED |
| 3. Permanent or legal address of registrant | ASCOT LABORATORIES LIMITED, 1 WARWICK PLACE, WARWICK ROAD, BOREHAMWOOD, WD6 1UA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ASCOT LABORATORIES LIMITED, 1 WARWICK PLACE, WARWICK ROAD, BOREHAMWOOD, WD6 1UA, 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 | 05/06/2026 |
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
ASCOT LABORATORIES LIMITED, 1 WARWICK PLACE, WARWICK ROAD, BOREHAMWOOD, WD6 1UA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| FINASTERIDE (1000007415) | HUNAN YUXIN PHARMACEUTICAL COMPANY LIMITED, LONGXUTANG, SHAOYANG, HUNAN, CN-422001, CHINA |
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| ATENOLOL (1000009849) | IPCA LABORATORIES LIMITED, PLOT NO.H-4, MIDC, WALUJ, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431136, INDIA |
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| HALOPERIDOL (1000001486) | RPG LIFE SCIENCES LIMITED, 25 MIDC LAND, THANE-BELAPUR ROAD, NAVI MUMBAI, MAHARASHTRA, IN-400703, INDIA |
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| GLYCOPYRRONIUM BROMIDE (2000011773) | SWATI SPENTOSE PRIVATE LIMITED, UNIT-I, PLOT NUMBER A-1/2102, 2103 AND A-2/2120, PHASE III, G.I.D.C., DISTRICT VALSAD, VAPI, GUJARAT, IN-396195, INDIA |
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| TINIDAZOLE (1000009326) | AARTI DRUGS LIMITED, PLOT NO. N-198, MIDC, TARAPUR, TALUKA PALGHAR, DISTRICT THANE, MAHARASHTRA, IN-401 506, INDIA |
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| OMEPRAZOLE (1000009101) | LEE PHARMA LIMITED, SURVEY NO. 10/G-1, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502319, INDIA |
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| GRISEOFULVIN (1000001953) | CHIFENG PHARMACEUTICAL COMPANY LIMITED, 84 YIDONG STREET, CHIFENG, HONGSHAN DISTRICT, INNER MONGOLIA, CN-024 001, CHINA |
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| SPIRONOLACTONE (1000009436) | TIANJIN JINJIN PHARMACEUTICAL COMPANY LIMITED, 8 JINGFU ROAD, INDUSTRIAL ZONE OF ZHANGJIAWO TOWN, XIQING DISTRICT, TIANJIN, CN-300387, CHINA |
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| BISACODYL (1000007386) | JPN PHARMA PRIVATE LIMITED, T-108/109, MIDC, TARAPUR, BOISAR, THANE DISTRICT, MAHARASHTRA, IN-401 506, INDIA |
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| FLECAINIDE ACETATE (2000007515) | EMCURE PHARMACEUTICALS LIMITED, D-24 & D-24/1, MIDC, KURKUMBH, TALUK DAUND, PUNE, MAHARASHTRA, IN-413802, INDIA |
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| AMIODARONE HYDROCHLORIDE (2000008524) | CTX LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA |
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| AZELAIC ACID (1000007411) | TYCHE INDUSTRIES LIMITED, 6/223, SARPAVARAM, KAKINADA, ANDHRA PRADESH, IN-533 005, INDIA |
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| LEVAMISOLE HYDROCHLORIDE (2000006314) | NANJING WHITE WHALE PHARMA, NO. 29 FANGSHUIDONG ROAD, NANJING JIANBEI NEW AREA, NANJING, CN-210047, CHINA |
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| PROBENECID (1000009786) | D K PHARMA CHEM PRIVATE LIMITED, F-32/W-7, MIDC BADLAPUR, MUMBAI, MAHARASHTRA, IN-421 503, INDIA |
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| TELMISARTAN (1000008495) | CALYX CHEMICALS AND PHARMACEUTICALS LIMITED, N/102/91/90 MIDC, TARAPUR, BOISAR, PALGHAR DISTRICT, MAHARASHTRA, IN-401 506, INDIA |
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| METRONIDAZOLE (1000001131) | WUHAN WUYAO PHARMACEUTICAL CO. LIMITED, 18 WANGFEN ROAD, FUCHI TOWN, YANGXIN COUNTY, HUANGSHI CITY, HUBEI, CN-435 229, CHINA |
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| TRETINOIN (1000009303) | CHONGQING HUAPONT SHENGCHEM PHARMACEUTICALS COMPANY LIMITED, NO.666 RONGJUN ROAD, NANJIN AVENUE, HECHUAN DISTRICT, CHONGQING, CN-401520, CHINA |
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| METFORMIN HYDROCHLORIDE (2000008338) | AURO LABORATORIES LIMITED, NAVAPUR ROAD, K-56 MIDC, BOISAR, DISTRICT TARAPUR, MAHARASHTRA, IND-401506, INDIA |
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| OXETACAINE (3000004664) | SUN PHARMACEUTICAL INDUSTRIES LIMITED, SATHAMMAI VILLAGE, KARUNKUZHI POST, MADHURANTHAGAM TALUK, KANCHEEPURAM DISTRICT, TAMIL NADU, IN-603303, INDIA |
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| BENZBROMARONE (1000003448) | IPCA LABORATORIES LIMITED, PLOT NOS. 4722, 4723, 4731 AND 4732, GIDC ESTATE, ANKLESHWAR DISTRICT, BHARUCH, IN-393002, INDIA |
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| LANSOPRAZOLE (1000007341) | NIFTY LABS PRIVATE LIMITED, PLOT NO 50-A,B, G&H, 64-A, B, C&D, 65-A, B, C&D, 66-A&B, 67-A&B, IDA KONDAPALLY, IBRAHIMPATNAM, MANDAL, NTR DISTRICT, ANDHRA PRADESH, IN-521 228, INDIA |
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| CLOBETASOL PROPIONATE (2000008014) | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
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| SULFAPYRIDINE (3000017230) | VIRCHOW DRUGS LIMITED, SURVEY NO. 639, TEMPLE ROAD, BONTHAPALLY VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, INDIA |
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| CLOPIDOGREL BISULFATE (4000011216) | PRAVEEN LABORATORIES PRIVATE LIMITED, BLOCK NO. 206, PALSANA TALUKA, JOLWA VILLAGE, SURAT, GUJARAT, IN-394305, INDIA |
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| TRANEXAMIC ACID (1000009308) | AMI LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 82/B, ECP ROAD, AT & PO, KARAKHADI, TA. PADRA, BARODA, IN 391450, INDIA |
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| SULFASALAZINE (3000009594) | VIRCHOW DRUGS LIMITED, SURVEY NO. 639, TEMPLE ROAD, BONTHAPALLY VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, INDIA |
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| TOFACITINIB (1000018860) | MICRO LABORATORIES LIMITED, API DIVISION (ML-15) PLOT 43-45 KIADB, ANEKAL TALUK, BOMMASANDRA-JIGANI LINK ROAD, BENGALURU, KARNATAKA, IN-560105, INDIA |
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| METHOXSALEN (1000007442) | SOLARA ACTIVE PHARMA SCIENCES LIMITED, 120 A & B, 36, 120P &121, INDUSTRIAL AREA, BAIKAMPADY, NEW MANGALORE, KARNATAKA, IN-575011, INDIA |
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| ENALAPRIL MALEATE (2000007672) | ZHEJIANG HUAHAI PHARMACEUTICAL COMPANY LIMITED, XUNQIAO, LINHAI, ZHEJIANG, CN-317024, CHINA |
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| RIFAXIMIN (1000007585) | MSN LABORATORIES PRIVATE LIMITED, SURVEY NOS 317, 320, 321, 322, 323, 604 & 605, RUDRARAM VILLAGE, PATANCHERU MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502329, INDIA |
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| MERCAPTOPURINE MONOHYDRATE (2000020211) | AARTI PHARMALABS LIMITED, UNIT IV - PLOT NO. E-50, 50/1 & 59/1 M.I.D.C, TALUKA PALGHAR, TARAPUR, DISTRICT PALGHAR, MAHARASHTRA, IN-401 506, INDIA |
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| EOSIN (1000005976) | JPN PHARMA PRIVATE LIMITED, T-108/109, MIDC, TARAPUR, BOISAR, THANE DISTRICT, MAHARASHTRA, IN-401 506, INDIA |
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| MINOXIDIL (1000000832) | KUMAR ORGANIC PRODUCTS LIMITED, PLOT NO. 60 & 65, ROAD NO. 3, JIGANI INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE, KARNATAKA, IN-560 105, INDIA |
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| TACROLIMUS MONOHYDRATE (2000016490) | CONCORD BIOTECH LIMITED, 1482-1486 TRASAD ROAD, DHOLKA, AHMEDABAD DISTRICT, GUJARAT, IN-382 225, INDIA |
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| OXANDROLONE (1000016028) | NURAY CHEMICALS PRIVATE LIMITED, GROUND FLOOR, PLOT NUMBER 111, SIDCO INDUSTRIAL ESTATE, KAKKALUR, THIRUVALLUR, TAMIL NADU, IN-602003, INDIA |
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| DITHRANOL (1000002937) | SUJALAM CHEMICALS, A-43 M.I.D.C., KURKUMBH, TAL, DAUND, DISTRICT PUNE, IN-413802, INDIA |
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| ACETAZOLAMIDE (1000002240) | CTX LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA |
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| MONOBENZONE (1000019033) | CHANGZHOU SUNLIGHT PHARMACEUTICAL COMPANY LIMITED, 216 YUNNAN WEST ROAD, BENNIU TOWN, XINBEI DISTRICT, CHANGZHOU CITY, JIANGSU PROVINCE, CN 213134, CHINA |
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| SIMVASTATIN (1000009116) | SUN PHARMACEUTICAL INDUSTRIES LIMITED, VILLAGE TOANSA, PO RAIL MAJRA, DISTRICT NAWANSHAHAR, PUNJAB, IN-144 533, INDIA |
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| AZATHIOPRINE (1000009761) | RPG LIFE SCIENCES LIMITED, 25 MIDC LAND, THANE-BELAPUR ROAD, NAVI MUMBAI, MAHARASHTRA, IN-400703, INDIA |
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| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
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| BECLOMETASONE DIPROPIONATE (4000006191) | AVIK PHARMACEUTICAL LIMITED, A-1/7 AND A-1/8, PHASE-1, GUJARAT INDUSTRIAL DEVELOPMENT CORPORATION AREA, VALSAD DISTRICT, VAPI, GUJURAT, IN-396195, INDIA |
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| DILTIAZEM HYDROCHLORIDE (2000007763) | DIVI'S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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| ETHAMBUTOL (1000002667) | CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294 GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA |
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| VALGANCICLOVIR HYDROCHLORIDE (2000006980) | AURORE PHARMACEUTICALS PRIVATE LIMITED, UNIT 1, PLOT NOS. 35, 36, 38 TO 40, 49 TO 51, PHASE IV, I.D.A., JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA |
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| PRAZOSIN HYDROCHLORIDE (2000007918) | NURAY CHEMICALS PRIVATE LIMITED, GROUND FLOOR, PLOT NUMBER 111, SIDCO INDUSTRIAL ESTATE, KAKKALUR, THIRUVALLUR, TAMIL NADU, IN-602003, INDIA |
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| SULFADIAZINE SILVER (2000007397) | MACSEN DRUGS, F-261,263,263 RIICO INDUSTRIAL AREA, GUDLI, TEHSIL- MAVLI, UDAIPUR, RAJASTHAN, IN-313024, INDIA |
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| NITAZOXANIDE (1000000749) | AZICO BIOPHORE INDIA PRIVATE LIMITED, PLOT NO. 40/A, JN PHARMACITY, PARAWADA MANDAL, ANAKAPALLI, ANDHRA PRADESH, IN-531021, INDIA |
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| HYDROQUINONE (1000008752) | MEDILUX LABORATORIES PRIVATE LIMITED, PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
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| ZONISAMIDE (1000003230) | ENAL DRUGS PRIVATE LIMITED, D-33, 34 & 35, PHASE 1, IDA, JEEDIMETLA, HYDERABAD, IN-500055, INDIA |
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| RAMIPRIL (1000009080) | MELODY HEALTHCARE PRIVATE LIMITED, PLOT NO. J-73, MIDC, DIST. PALGHAR, TARAPUR, MAHARASHTRA, IN-401506, INDIA |
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| CLONIDINE HYDROCHLORIDE (2000008010) | ALEMBIC PHARMACEUTICALS LIMITED, UNIT I, P.O. TAJPURA, NEAR BASKA, TALUKA HALOL, PANCHMAHAL DISTRICT, PANELAV VILLAGE, GUJARAT, IN-389350, INDIA |
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| AMLODIPINE BESILATE (2000015864) | IPCA LABORATORIES LIMITED, PLOT NO.H-4, MIDC, WALUJ, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431136, INDIA |
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| CHLOROTHIAZIDE (1000004605) | CTX LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA |
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| PRAZIQUANTEL (1000015572) | SOLARA ACTIVE PHARMA SCIENCES LIMITED, 120 A & B, 36, 120P &121, INDUSTRIAL AREA, BAIKAMPADY, NEW MANGALORE, KARNATAKA, IN-575011, INDIA |
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| PYRAZINAMIDE (1000009751) | ANUH PHARMA LIMITED, E-17/3 & E-17/4 & E-18 M.I.D.C., BOISAR, TARAPUR, TALUKA PALGHAR, THANE, MAHARASHTRA, IN-401506, INDIA |
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| FLUNARIZINE DIHYDROCHLORIDE (4000009677) | FLEMING LABORATORIES LIMITED, SURVEY NUMBER 270, NAWABPET VILLAGE, SIVAMPET MANDAL, MEDAK DISTRICT, TELANGANA, IN-502313, INDIA |
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| ISONIAZID (1000007745) | AMSAL CHEM PRIVATE LIMITED, A-1/ 401, 402, 403 G.I.D.C. INDUSTRIAL ESTATE, DISTRICT BHARUCH, ANKLESHWAR, GUJARAT, IN-393002, INDIA |
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| NADOLOL (1000000391) | AZICO BIOPHORE INDIA PRIVATE LIMITED, PLOT NO. 40/A, JN PHARMACITY, PARAWADA MANDAL, ANAKAPALLI, ANDHRA PRADESH, IN-531021, INDIA |
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| IVERMECTIN (1000001158) | BAJAJ HEALTHCARE LIMITED, UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, INDIA |
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| ORPHENADRINE CITRATE (2000008058) | HARIKA DRUGS PRIVATE LIMITED, SURVEY NO. 165/A & 165/E, GUMMADIDALA VILLAGE, MEDAK DISTRICT, TELANGANA, IN-500 038, INDIA |
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| PROPRANOLOL (1000009764) | IPCA LABORATORIES LIMITED, P.O. SEJAVTA, RATLAM, MADHYA PRADESH, IN-457002, INDIA |
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| BETAMETHASONE DIPROPIONATE (2000008360) | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
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| CARVEDILOL (1000003761) | CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294 GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA |
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| PHENELZINE SULFATE (4000007420) | TYCHE INDUSTRIES LIMITED, 6/223, SARPAVARAM, KAKINADA, ANDHRA PRADESH, IN-533 005, INDIA |
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| SODIUM BENZOATE (2000013061) | GANESH BENZOPLAST LIMITED, D-21/2/2 MIDC INDUSTRIAL AREA, TARAPUR, MAHARASHTRA, IN-401506, INDIA |
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| METOLAZONE (1000001205) | AZICO BIOPHORE INDIA PRIVATE LIMITED, PLOT NO. 40/A, JN PHARMACITY, PARAWADA MANDAL, ANAKAPALLI, ANDHRA PRADESH, IN-531021, INDIA |
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| LOPERAMIDE HYDROCHLORIDE (2000008494) | VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 39 A & B, PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN-500055, INDIA |
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| CAPSAICIN (1000006807) | AUDI PHARMACEUTICALS PRIVATE LIMITED, D/9/B, 27TH CROSS STREET, MAHARAJANAGAR, TIRUNELVELI, TAMIL NADU, IN-627011, INDIA |
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| SODIUM PHENYLBUTYRATE (2000005746) | SRI KRISHNA PHARMACEUTICALES LIMITED, UNIT III, SURVEY NO 57, GOLKONDA KALAN, RAIKUNTA VILLAGE, SHAMSHABAD MANDAL, TELANGANA, IN-501218, INDIA |
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| TOPIRAMATE (1000002932) | MSN ORGANICS PRIVATE LIMITED, SURVEY NUMBER 224/A, BIBINAGAR MANDAL, YADADRI BHUVANAGIRI DISTRICT, BIBINAGAR VILLAGE, TELANGANA, IN-508126, INDIA |
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| LIDOCAINE HYDROCHLORIDE (2000014083) | SWATI SPENTOSE PRIVATE LIMITED, UNIT-I, PLOT NUMBER A-1/2102, 2103 AND A-2/2120, PHASE III, G.I.D.C., DISTRICT VALSAD, VAPI, GUJARAT, IN-396195, INDIA |
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| BETAMETHASONE VALERATE (2000008358) | SANJIVANI PHARMA, D2/CH/102 GIDC INDUSTRIAL ESTATE, VAGRA, BHARUCH, GUJARAT, IN-392130, INDIA |
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| SUCRALFATE (1000009411) | SNJ LABS PRIVATE LIMITED, PLOT NO 5-16, SURVEY NO. 137, AT & POST, PADAVALA, KOTDA SANGANI, RAJKOT, GUJARAT, IN-360024, INDIA |
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| MEXILETINE HYDROCHLORIDE (2000008257) | BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 80A, ROAD NO: 05, JAWAHARLAL NEHRU PHARMA CITY, E.BONANGI (VILLAGE), PARAWADA (MANDAL), VISAKHAPATNAM, ANDHRA PRADESH, IN-531021, INDIA |
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| SERTRALINE HYDROCHLORIDE (2000008378) | HARIKA DRUGS PRIVATE LIMITED, SURVEY NO. 165/A & 165/E, GUMMADIDALA VILLAGE, MEDAK DISTRICT, TELANGANA, IN-500 038, INDIA |
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| CYCLIZINE HYDROCHLORIDE (2000007923) | SRIKEM LABORATORIES PRIVATE LIMITED, PLOT NO. 17/22, 17/23, 17/24, 17/13 MIDC, TALOJA, NAVI MUMBAI, MAHARASHTRA, IN-410 208, INDIA |
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| CAFFEINE (1000007507) | SHANDONG XINHUA PHARMACEUTICAL CO. LIMITED, EAST CHEMICAL ZONE OF ZIBO HIGH & NEW TECHNOLOGY DEVELOPMENT ZONE, ZHANGDIAN DISTRICT, ZIBO, SHANDONG, CN-255 075, CHINA |
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| LEVOTHYROXINE SODIUM (2000013292) | AURORE PHARMACEUTICALS PRIVATE LIMITED, UNIT 1, PLOT NOS. 35, 36, 38 TO 40, 49 TO 51, PHASE IV, I.D.A., JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA |
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| MELATONIN (1000000731) | SWATI SPENTOSE PRIVATE LIMITED, UNIT-I, PLOT NUMBER A-1/2102, 2103 AND A-2/2120, PHASE III, G.I.D.C., DISTRICT VALSAD, VAPI, GUJARAT, IN-396195, INDIA |
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