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 | 29/09/2025 |
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
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 | |
| 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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| OMEPRAZOLE (1000009101) | LEE PHARMA LIMITED, SURVEY NO. 10/G-1, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502319, 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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| SODIUM BENZOATE (2000013061) | GANESH BENZOPLAST LIMITED, D-21/2/2 MIDC INDUSTRIAL AREA, TARAPUR, MAHARASHTRA, IN-401506, 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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| IVERMECTIN (1000001158) | BAJAJ HEALTHCARE LIMITED, UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, 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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| CLOPIDOGREL BISULFATE (4000011216) | PRAVEEN LABORATORIES PRIVATE LIMITED, BLOCK NO. 206, PALSANA TALUKA, JOLWA VILLAGE, SURAT, GUJARAT, IN-394305, 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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| 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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| 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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| ZONISAMIDE (1000003230) | ENAL DRUGS PRIVATE LIMITED, D-33, 34 & 35, PHASE 1, IDA, JEEDIMETLA, HYDERABAD, IN-500055, 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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| METFORMIN HYDROCHLORIDE (2000008338) | AURO LABORATORIES LIMITED, NAVAPUR ROAD, K-56 MIDC, BOISAR, DISTRICT TARAPUR, MAHARASHTRA, IND-401506, INDIA |
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| FINASTERIDE (1000007415) | HUNAN YUXIN PHARMACEUTICAL COMPANY LIMITED, LONGXUTANG, SHAOYANG, HUNAN, CN-422001, CHINA |
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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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| 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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| SULFAPYRIDINE (3000017230) | VIRCHOW DRUGS LIMITED, SURVEY NO. 639, TEMPLE ROAD, BONTHAPALLY VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, 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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| 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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| RASAGILINE MESYLATE (2000005590) | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 3109, G.I.D.C. INDUSTRIAL ESTATE, ANKLESHWAR, BHARUCH DISTRICT, 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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| 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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| 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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| 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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| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
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| HALOPERIDOL (1000001486) | RPG LIFE SCIENCES LIMITED, 25 MIDC LAND, THANE-BELAPUR ROAD, NAVI MUMBAI, MAHARASHTRA, IN-400 703, 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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| CARVEDILOL (1000003761) | CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294 GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, 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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| 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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| 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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| RAMIPRIL (1000009080) | MELODY HEALTHCARE PRIVATE LIMITED, PLOT NO. J-73, MIDC, DIST. PALGHAR, TARAPUR, MAHARASHTRA, IN-401506, 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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| 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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| 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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| 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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| 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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| DILTIAZEM HYDROCHLORIDE (2000007763) | DIVI'S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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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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| AZATHIOPRINE (1000009761) | RPG LIFE SCIENCES LIMITED, 25 MIDC LAND, THANE-BELAPUR ROAD, NAVI MUMBAI, MAHARASHTRA, IN-400 703, INDIA |
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| MIDAZOLAM HYDROCHLORIDE (2000008252) | LAKE CHEMICALS PRIVATE LIMITED, SITE NO 21M, ATTIBELE INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-562 107, 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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| SOLIFENACIN SUCCINATE (2000006491) | MICRO LABORATORIES LIMITED, PLOT 43-45 KIADB, ANEKAL TALUK, BOMMASANDRA-JIGANI LINK ROAD, BENGALURU, KARNATAKA, IN-560105, 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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| 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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| DITHRANOL (1000002937) | SUJALAM CHEMICALS, A-43 M.I.D.C., KURKUMBH, TAL, DAUND, DISTRICT PUNE, IN-413802, 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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| 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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| LEVAMISOLE HYDROCHLORIDE (2000006314) | NANJING WHITE WHALE PHARMA, NO. 29 FANGSHUIDONG ROAD, NANJING JIANBEI NEW AREA, NANJING, CN-210047, CHINA |
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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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| 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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| FLECAINIDE ACETATE (2000007515) | EMCURE PHARMACEUTICALS LIMITED, D-24 & D-24/1, MIDC, KURKUMBH, TALUK DAUND, PUNE, MAHARASHTRA, IN-413802, 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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| ATENOLOL (1000009849) | IPCA LABORATORIES LIMITED, PLOT NO.H-4, MIDC, WALUJ, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431136, 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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| 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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| BENZBROMARONE (1000003448) | IPCA LABORATORIES LIMITED, PLOT NOS. 4722, 4723, 4731 AND 4732, GIDC ESTATE, ANKLESHWAR DISTRICT, BHARUCH, IN-393002, INDIA |
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| TOFACITINIB (1000018860) | MICRO LABORATORIES LIMITED, PLOT 43-45 KIADB, ANEKAL TALUK, BOMMASANDRA-JIGANI LINK ROAD, BENGALURU, KARNATAKA, IN-560105, 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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| 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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| PROPRANOLOL (1000009764) | IPCA LABORATORIES LIMITED, P.O. SEJAVTA, RATLAM, MADHYA PRADESH, IN-457002, 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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| ETHAMBUTOL (1000002667) | CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294 GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, 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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| SIMVASTATIN (1000009116) | SUN PHARMACEUTICAL INDUSTRIES LIMITED, VILLAGE TOANSA, PO RAIL MAJRA, DISTRICT NAWANSHAHAR, PUNJAB, IN-144 533, 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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| PHENELZINE SULFATE (4000007420) | TYCHE INDUSTRIES LIMITED, 6/223, SARPAVARAM, KAKINADA, ANDHRA PRADESH, IN-533 005, INDIA |
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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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| 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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| 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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| 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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| OXETACAINE (3000004664) | SUN PHARMACEUTICAL INDUSTRIES LIMITED, SATHAMMAI VILLAGE, KARUNKUZHI POST, MADHURANTHAGAM TALUK, KANCHEEPURAM DISTRICT, TAMIL NADU, IN-603303, INDIA |
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| ENALAPRIL MALEATE (2000007672) | ZHEJIANG HUAHAI PHARMACEUTICAL COMPANY LIMITED, XUNQIAO, LINHAI, ZHEJIANG, CN-317024, CHINA |
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| AZELAIC ACID (1000007411) | TYCHE INDUSTRIES LIMITED, 6/223, SARPAVARAM, KAKINADA, ANDHRA PRADESH, IN-533 005, INDIA |
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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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