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

Registrant Details
1. Registration NumberUK API 1375
2. Name or corporate name of registrantR W UNWIN & COMPANY LIMITED
3. Permanent or legal address of registrant R W UNWIN & COMPANY LIMITED, MANSELLS FARM, HITCHIN ROAD, CODICOTE, HITCHIN, SG4 8TJ, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

R W UNWIN & CO LTD, MANSELLS FARM, HITCHIN ROAD, CODICOTE, HITCHIN, SG4 8TJ, UNITED KINGDOM

5. National legal basis of registration
6. Name of responsible officer of the competent authority of the member state validating the registration Confidential
7. Date 20/11/2023

 

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

Name and address of the site

R W UNWIN & CO LTD, MANSELLS FARM, HITCHIN ROAD, CODICOTE, HITCHIN, SG4 8TJ, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
Active Substance 3rd Country Manufacturer 3rd Country Distributor
PRASTERONE (1000006301)

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP., SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

NIACINAMIDE (4000009993)

TIANJIN ZHONGRUI PHARMACEUTICAL CO LIMITED, EASTERN BEIHUAN ROAD, CHENGGUAN TOWN, WUQING DISTRICT, TIANJIN CITY, CN-301712, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

BUTYLATED HYDROXYTOLUENE (1000008611)

PENTA INTERNATIONAL CORP., 50 OKNER PARKWAY, LIVINGSTON, 07039-1604, UNITED STATES

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

CHLORPHENAMINE MALEATE (4000007290)

KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA, JP-930-0912, JAPAN

SODIUM SALICYLATE (2000007480)

JQC (HUAYIN) PHARMACEUTICAL COMPANY LIMITED, YUQUAN ROAD, HUAYIN CITY, SHAANXI, CN-714203, CHINA

TACROLIMUS (1000002882)

BIOCON, BIOCON HOUSE, SEMICON PARK, 1ST FLOOR, ELECTRONICS CITY PHASE 2, BANGALORE, IN- 560100, INDIA

ESTRADIOL VALERATE (2000016109)

ZHEJIANG XIANJU PHARMACEUTICAL CO LIMITED, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

FOLIC ACID (1000001996)

DSM NUTRITIONAL PRODUCTS AG, ZWEIGNIEDERLASSUNG WERK SISSELN, HAUPSTRASSE 4, SISSELN, CH-43334, SWITZERLAND

OMEPRAZOLE (1000009101)

EVEREST ORGANICS LIMITED, LAKEVIEW PLAZA PLOT NO. 127 & 128, AMAR CO-OP. SOCIETY, NEAR DURGAMCHERVU, MADHAPUR, HYDERABAD, TELANGANA, IN-500 033, INDIA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

TETRACAINE (1000012475)

VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED ( FORMERLY NUTRA SPECIALITIES PRIVATE LIMITED), VENKATA NARAYANA TOWERS, 3RD FLOOR, NEW NO 60, OLD NO 35 VENKATA NARAYANA ROAD, THEAGARAYA NAGAR, CHENNAI, TAMIL NADU, IN-600017, INDIA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829)

MALLADI DRUGS & PHARMACEUTICALS LIMITED, 9 GST ROAD, ST THOMAS MOUNT, CHENNAI, IN-600 016, INDIA

TOPIRAMATE (1000002932)

BIOCON, BIOCON HOUSE, SEMICON PARK, 1ST FLOOR, ELECTRONICS CITY PHASE 2, BANGALORE, IN- 560100, INDIA

OCEANIC PHARMACHEM, 329 A-Z INDUSTRIAL ESTATE, G.KADAM MARG, LOWER PAREL, MUMBAI, IN- 400 013, INDIA

ZOPICLONE (1000009091)

CENTAUR PHARMACEUTICALS PRIVATE LIMITED, PLOT NO 75, 76 & 76/1, CHIKHLOLI MIDC, AMBERNATH (WEST), THANE, MAHARASHTRA, IN-421 501, INDIA

SIROLIMUS (1000008469)

BIOCON, BIOCON HOUSE, SEMICON PARK, 1ST FLOOR, ELECTRONICS CITY PHASE 2, BANGALORE, IN- 560100, INDIA

HYDROQUINONE (1000008752)

MEDILUX LABORATORIES PVT LIMITED, PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

TRANEXAMIC ACID (1000009308)

HUNAN DONGTING, PHARMACEUTICAL CO. LIMITED, NO.16 DONGYANG ROAD, CHENJIAGANG COMMUNITY, DESHAN SUB-DISTRICT OFFICE, CHANGDE ECONOMIC AND TECHNICAL DEVELOPMENT ZONE, CHANGDE CITY, HUNAN PROVINCE, CN-415001, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

BETAMETHASONE VALERATE (2000008358)

SYMBIOTICA, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

7-KETO-DHEA (3000019722)

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP., SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

SODIUM CYCLAMATE (1000008715)

ZHONG HUA FANG DA (H.K) LIMITED, YANGQUAN ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, DALIAN ROAD, SHANXI, CN-045000, CHINA

BANANA FLAVOUR (1000006200)

FLAVORX, 9475 GERWIG LANE, COLUMBIA, 21046, UNITED STATES

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

PHENYLEPHRINE BITARTRATE (4000007411)

MALLADI DRUGS & PHARMACEUTICALS LIMITED, 9 GST ROAD, ST THOMAS MOUNT, CHENNAI, IN-600 016, INDIA

SIMVASTATIN (1000009116)

BIOCON, BIOCON HOUSE, SEMICON PARK, 1ST FLOOR, ELECTRONICS CITY PHASE 2, BANGALORE, IN- 560100, INDIA

VANILLIN (1000008735)

SOLVAY USA INC, 1275 AIRLINE HIGHWAY, BATON ROUGE, 70805-1002, UNITED STATES

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

AMLODIPINE BESILATE (2000015864)

MALLADI DRUGS & PHARMACEUTICALS LIMITED, 9 GST ROAD, ST THOMAS MOUNT, CHENNAI, IN-600 016, INDIA

ESTRADIOL HEMIHYDRATE (2000016108)

ZHEJIANG XIANJU PHARMACEUTICAL CO LIMITED, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

ZINC SULPHATE MONOHYDRATE (4000010708)

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP., SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

CLINDAMYCIN PHOSPHATE (2000008016)

ZHEJIANG TIANTAI PHARMACEUTICAL CO. LIMITED, 588 FENGZE ROAD, TAIZHOU CITY, TIANTAI COUNTY, ZHEJIANG PROVINCE, CN-317200, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

PHENYLEPHRINE (1000009891)

MALLADI DRUGS & PHARMACEUTICALS LIMITED, 9 GST ROAD, ST THOMAS MOUNT, CHENNAI, IN-600 016, INDIA

PREGNENOLONE (1000011186)

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP., SANHUANGMIAO, WUJIN, CHANGZHOU, ZHENGLU, JIANGSU, CN-213 111, CHINA

MEDISCA, 661 ROUTE 3, UNIT C, PLATTSBURGH, 12901, UNITED STATES

PROTAMINE SULPHATE (4000010193)

YUKI GOSEI KOGYO COMPANY LIMITED, 788 OCHIAI, JOBAN NISHIGO-MACHI, IWAKI-SHI, FUKUSHIMA PREFECTURE, JP-972-8316, JAPAN

PILOCARPINE (1000009876)

SOURCETECH QUIMICA LIMITADA, RUA SUICA 3430, PINDAMONHANGABA-SP, BR-12403 610, BRAZIL

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
ZINC PYRITHIONE (4000008930)
PREDNISOLONE SODIUM PHOSPHATE (2000007914)
PRASTERONE (1000006301)
CLONAZEPAM (1000004077)
ISOSORBIDE-5-MONONITRATE DILUTED IN LACTOSE 80/20 (4000013959)
ISOSORBIDE-5-MONONITRATE DILUTED IN LACTOSE 25/75 (4000013958)
LEVOTHYROXINE SODIUM (2000013292)
DISOPYRAMIDE PHOSPHATE (2000007751)
FENOFIBRATE (1000002301)
LIDOCAINE HYDROCHLORIDE (2000014083)
PROGESTERONE (1000009777)
NIACINAMIDE (4000009993)
IMIPRAMINE PAMOATE (2000016944)
D-BIOTIN (3000009891)
CHLOROTHIAZIDE (1000004605)
ISOSORBIDE 5-MONONITRATE (4000006581)
CARBAMAZEPINE (1000006757)
TRIAMTERENE (1000009300)
BUTYLATED HYDROXYTOLUENE (1000008611)
METRONIDAZOLE BENZOATE (2000008258)
MEDROXYPROGESTERONE ACETATE (2000008411)
CHLORPHENAMINE MALEATE (4000007290)
BISOPROLOL FUMARATE (2000008290)
ESOMEPRAZOLE SODIUM (2000006223)
NITROFURANTOIN (1000009675)
DISODIUM CLODRONATE (4000002029)
BENPERIDOL (1000009246)
AMILORIDE HYDROCHLORIDE (2000008529)
CYCLOSPORINE (3000005991)
IBUPROFEN LYSINATE (4000009786)
SODIUM SALICYLATE (2000007480)
BENZOYL PEROXIDE (1000009105)
CLOMIPRAMINE HYDROCHLORIDE (2000008121)
NALTREXONE BASE (3000019121)
LOPERAMIDE HYDROCHLORIDE (2000008494)
KETAMINE HYDROCHLORIDE (2000008609)
KETAZOLAM (1000008510)
HYDROCORTISONE SODIUM SUCCINATE (2000007334)
PIROXICAM (1000009856)
PINDOLOL (1000009872)
ADAPALENE (1000002293)
TESTOSTERONE PROPIONATE (2000007380)
NALOXONE HYDROCHLORIDE (2000008238)
CODEINE HYDROBROMIDE (2000016937)
KETOPROFEN LYSINATE (2000015216)
ETHOSUXIMIDE (1000002600)
TACROLIMUS (1000002882)
ISOTRETINOIN (1000008223)
AMLODIPINE (1000009119)
ESTRADIOL VALERATE (2000016109)
METAMPHETAMINE HYDROCLORIDE (2000009441)
GLYCOPYRROLATE (4000009718)
QUETIAPINE FUMARATE (2000005649)
OXYBUTYNIN HYDROCHLORIDE (2000008318)
DEXAMETHASONE (1000003334)
FINASTERIDE (1000007415)
METRONIDAZOLE (1000001131)
NITRAZEPAM (1000009676)
TOLTERODINE TARTRATE (2000013355)
CLONIDINE HYDROCHLORIDE (2000008010)
TIZANIDINE HYDROCHLORIDE (2000008572)
RIFAMPICIN (1000009725)
GLYCINE (1000012477)
AMINOSALICYLIC ACID (1000008930)
BENZBROMARONE (1000003448)
CYPROTERONE ACETATE (2000007860)
PERPHENAZINE (1000009586)
ADRENALINE TARTRATE (4000006411)
ALIMEMAZINE TARTRATE (4000006319)
RANITIDINE HYDROCHLORIDE (2000007813)
DIHYDROCODEINE (1000003082)
CHLORTALIDONE (3000004761)
BOSENTAN MONOHYDRATE (2000005705)
CAFFEINE ANHYDROUS (3000005457)
GLYCERINE (3000000199)
TRIHEXYPHENIDYL HYDROCHLORIDE (4000006899)
TESTOSTERONE (1000009354)
TIZANIDINE (1000007875)
PERPHENAZINE ENANTATE (2000015324)
KETOPROFEN (1000008346)
ISOSORBIDE-5-MONONITRATE DILUTED IN LACTOSE 40/60 (4000013961)
LOTEPREDNOL ETABONATE (2000006253)
ISOSORBIDE DINITRATE IN LACTOSE MIXTURE 25:75% (4000008090)
IBUPROFEN SODIUM (2000011939)
FOLIC ACID (1000001996)
CHLORDIAZEPOXIDE (1000004715)
DICYCLOMINE HYDROCHLORIDE (2000007772)
BROMAZEPAM (1000007272)
NALTREXONE HYDROCHLORIDE (2000007614)
OMEPRAZOLE (1000009101)
BACLOFEN (1000009324)
SPIRONOLACTONE (1000009436)
OXCARBAZEPINE (1000003329)
LORAZEPAM (1000008543)
MINOXIDIL (1000000832)
CHOLESTEROL POWDER (3000021666)
MEMANTINE HYDROCHLORIDE (2000006625)
TETRACAINE (1000012475)
BIOTIN (1000007405)
MORPHINE HYDROCHLORIDE (2000008247)
PENTAZOCINE (1000009591)
DIAZEPAM (1000003208)
PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829)
BUSULFAN (3000005691)
PROPRANOLOL HYDROCHLORIDE (2000007892)
TRIMEPRAZINE TARTRATE (2000008580)
HYDROCORTISONE ACETATE (2000007338)
HYDROCORTISONE (1000008762)
ISOSORBIDE-5-MONONITRATE DILUTED IN LACTOSE 90/10 (4000013960)
BENDAMUSTINE HYDROCHLORIDE (2000006919)
TOPIRAMATE (1000002932)
PENTAZOCINE HYDROCHLORIDE (2000008082)
PROCHLORPERAZINE MALEATE (2000007903)
PERPHENAZINE DECANOATE (2000015323)
ZOPICLONE (1000009091)
NITROFURANTOIN MONOHYDRATE (2000009285)
SIROLIMUS (1000008469)
HYDROQUINONE (1000008752)
TEMAZEPAM (1000009363)
BENDROFLUMETHIAZIDE (3000006463)
DEXAMPHETAMINE SULPHATE (2000007842)
DOTHIEPIN HYDROCHLORIDE (4000013248)
TRANEXAMIC ACID (1000009308)
TESTOSTERONE MICRONISED (2000018723)
SELEGILINE HYDROCHLORIDE (2000007734)
MERCAPTOPURINE (1000000947)
PHOLCODINE (1000009886)
TOLAZAMIDE (1000009316)
OXAZEPAM (1000009641)
AMPHETAMINE SULPHATE (2000010810)
BETAMETHASONE VALERATE (2000008358)
DIPYRIDAMOLE (1000002962)
CLOBAZAM (1000004171)
RAMIPRIL (1000009080)
TESTOSTERONE ENANTATE (4000006624)
DIETHYLPROPION HYDROCHLORIDE (2000007770)
TAMOXIFEN CITRATE (2000007386)
7-KETO-DHEA (3000019722)
AZATHIOPRINE (1000009761)
TRANYLCYPROMINE SULPHATE (2000008589)
METHADONE HYDROCHLORIDE (2000008337)
SODIUM CYCLAMATE (1000008715)
METHADONE (1000000638)
ZONISAMIDE (1000003230)
ISOSORBIDE DINITRATE (2000008057)
CHLORAL HYDRATE (1000005193)
GUANIDINE NITRATE (2000018151)
BANANA FLAVOUR (1000006200)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)
AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310)
PHENYLEPHRINE BITARTRATE (4000007411)
IOHEXOL (1000007901)
ACYCLOVIR (1000007387)
SIMVASTATIN (1000009116)
PROMAZINE HYDROCHLORIDE (2000007897)
ESOMEPRAZOLE MAGNESIUM (2000006165)
OXYBUTYNIN (1000009086)
FUROSEMIDE (3000005943)
SELENIUM SULFIDE (3000010141)
DANAZOL (1000003803)
FINASTERIDE MICRONISED (2000018155)
DILTIAZEM HYDROCHLORIDE (2000007763)
TRAMADOL (1000007320)
BETAHISTINE DIHYDROCHLORIDE (4000007579)
DICLOFENAC FREE ACID (3000008741)
BUPIVACAINE HYDROCHLORIDE (2000008278)
DEQUALINIUM CHLORIDE (2000007849)
METOPROLOL TARTRATE (2000008259)
TRIFLUOPERAZINE HYDROCHLORIDE (2000008581)
VANILLIN (1000008735)
DICLOFENAC SODIUM (2000007774)
CHLORDIAZEPOXIDE HYDROCHLORIDE (2000008104)
TESTOSTERONE CIPIONATE (2000015349)
PERAZINE DIMALONATE (2000014601)
AMLODIPINE BESILATE (2000015864)
DICLOFENAC POTASSIUM (2000005773)
PROCHLORPERAZINE (1000009780)
METFORMIN HYDROCHLORIDE (2000008338)
ESTRADIOL HEMIHYDRATE (2000016108)
CLIDINIUM BROMIDE (2000008018)
NEOMYCIN SULPHATE (2000008175)
OXYCODONE HYDROCHLORIDE (2000006722)
IMIPRAMINE HYDROCHLORIDE (2000007321)
ESOMEPRAZOLE (1000000848)
ZINC SULPHATE MONOHYDRATE (4000010708)
PROCYCLIDINE HYDROCHLORIDE (2000007901)
SILDENAFIL CITRATE (2000006954)
LIDOCAINE BASE (3000009760)
AZELAIC ACID (1000007411)
CLOTRIMAZOLE (1000003999)
ESTRADIOL BENZOATE (2000016107)
MORPHINE SULPHATE (2000008246)
CLINDAMYCIN PHOSPHATE (2000008016)
MONOPROPYLENE GLYCOL (3000001144)
NIFEDIPINE (1000009680)
BENAZEPRIL HYDROCHLORIDE (2000006111)
ZINC SULFATE (4000006810)
PHENYLEPHRINE (1000009891)
ACETAZOLAMIDE (1000002240)
PHENYTOIN BASE (2000019342)
PREGNENOLONE (1000011186)
NIMODIPINE (1000009678)
SODIUM CROMOGLICATE (4000007084)
THIORIDAZINE HYDROCHLORIDE (2000008605)
INDOMETHACIN (1000008682)
PROTAMINE SULPHATE (4000010193)
AMITRIPTYLINE HYDROCHLORIDE (2000008522)
MEPIVACAINE HYDROCHLORIDE (2000008341)
MIDAZOLAM (1000000928)
PROCHLORPERAZINE EDISYLATE (2000016947)
NITROFURANTOIN MACROCRYSTALS (3000007709)
TRETINOIN (1000009303)
DIHYDROCODEINE TARTRATE (2000007767)
PILOCARPINE (1000009876)
ORPHENADRINE HYDROCHLORIDE (2000008157)