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 39574
2. Name or corporate name of registrantFAGRON UK LIMITED
3. Permanent or legal address of registrant FAGRON UK LIMITED, MEDIA EXCHANGE, 4B COQUET STREET, NEWCASTLE UPON TYNE, NE1 2QB, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

FAGRON UK LIMITED, MEDIA EXCHANGE, 4B COQUET STREET, NEWCASTLE UPON TYNE, NE1 2QB, 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 19/08/2026

 

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

Name and address of the site

FAGRON UK LIMITED, MEDIA EXCHANGE, 4B COQUET STREET, NEWCASTLE UPON TYNE, NE1 2QB, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
Active Substance 3rd Country Manufacturer 3rd Country Distributor
SILDENAFIL CITRATE (2000006954)

SMS LIFESCIENCES INDIA LIMITED, KHAZIPALLY VILLAGE, JINNARAM MANDAL, HYDERABAD, MEDAK DISTRICT, IN-502 319, INDIA

NALTREXONE HYDROCHLORIDE (2000007614)

LETCO MEDICAL, LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

CHLOROTHIAZIDE (1000004605)

CTX LIFESCIENCES PVT LIMITED., BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA

PROGESTERONE (1000009777)

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

HYDROQUINONE (1000008752)

LETCO MEDICAL, LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

EXEMESTANE (1000000183)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

BENZOCAINE (1000009160)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

TESTOSTERONE MICRONISED (2000018723)

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

TETRACAINE (1000012475)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

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

LIOTHYRONINE SODIUM (2000008504)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

ADRENALINE TARTRATE (4000006411)

WUHAN WUYAO PHARMACEUTICAL CO., LIMITED, 18 WANGFEN ROAD, FUCHI TOWN, YANGXIN COUNTY, HUANGSHI CITY, HUBEI, CN-435 229, CHINA

THYROID (1000007072)

LETCO MEDICAL, LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

CLOMIPRAMINE HYDROCHLORIDE (2000008121)

R.L. FINE CHEM PRIVATE LIMITED, PLOT NO. IP NO. 27-29, PARTS OF SY NOS 18, 273, 274 & 313, KIADB INDUSTRIAL AREA, I PHASE, KUDAMALAKUNTE VILLAGE, GOWRIBIDANOOR TALUK, CHIKKABALLAPURA DISTRICT, IN-561208, INDIA

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

PRASTERONE (1000006301)

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

FINASTERIDE (1000007415)

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

CAFFEINE (1000007507)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

TACROLIMUS (1000002882)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

KETOCONAZOLE (1000008441)

PIRAMAL PHARMA LIMITED, SURVEY NOS. 7-70, 70/1 AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, KOHIR CROSS ROAD, SANGAREDDY DISTRICT, TELANGANA, IN-502321, INDIA

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

ENCLOMIPHENE CITRATE (2000022138)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

IVERMECTIN (1000001158)

ZHEJIANG HISUN PHARMACEUTICAL CO. LIMITED, 56 BINHAI ROAD, JIAOJIANG DISTRICT, TAIZHOU CITY, ZHEJIANG PROVINCE, CN-318000, CHINA

VERAPAMIL HYDROCHLORIDE (2000008484)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

TADALAFIL (1000000162)

ZHEJIANG HUAHAI PHARMACEUTICAL CO.LTD, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA

SUCRALFATE (1000009411)

ZHEJIANG HAISEN PHARMACEUTICAL CO LIMITED, LIUSHI STREET, DONGYANG CITY, ZHEJIANG, CN-322104, CHINA

ADAPALENE (1000002293)

BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA

MINOXIDIL (1000000832)

KUMAR ORGANICS PRODUCTS LIMITED, PLOT NO. 60/65, 62 & 64, ROAD NO. 3 & 5, JIGANI INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE, KARNATAKA, IN-560105, INDIA

TRETINOIN (1000009303)

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICALS COMPANY LIMITED, NO.666 RONGJUN ROAD, NANJIN AVENUE, HECHUAN DISTRICT, CHONGQING, CN-401520, CHINA

ESTRADIOL HEMIHYDRATE (2000016108)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

ESTRIOL (3000004591)

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

LETCO MEDICAL LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

PREGNENOLONE (1000011186)

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

LETCO MEDICAL, LLC, 1316 COMMERCE DRIVE, DECATUR, 35601-7539, UNITED STATES

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
HYDROCHLOROTHIAZIDE (1000008764)
TETRACAINE HYDROCHLORIDE (2000010807)
SILDENAFIL CITRATE (2000006954)
GLYCEROL (1000001659)
AMPHOTERICIN B (1000012483)
CADE OIL (4000009842)
IODINE (1000008377)
MACROGOL 1000 (1000007757)
CASTOR OIL (2000011186)
CALCIUM CITRATE ANHYDROUS (4000009380)
NALTREXONE HYDROCHLORIDE (2000007614)
RIBOFLAVIN (4000010954)
THIAMINE HYDROCHLORIDE (4000010937)
LIDOCAINE HYDROCHLORIDE (2000014083)
ALUMINIUM SULPHATE (1000002620)
CHLOROTHIAZIDE (1000004605)
NIFEDIPINE (1000009680)
CYSTEINE HYDROCHLORIDE (2000007859)
GLYCINE (1000012477)
CALCIUM GLUCONATE MONOHYDRATE (4000009385)
MAGNESIUM CHLORIDE (2000012207)
HYDROXYCHLOROQUINE SULFATE (4000006673)
MACROGOL 300 (1000009031)
7-KETO-DEHYDROEPIANDROSTERONE (1000019708)
PREGNENOLONE ACETATE (2000009822)
AMILORIDE HYDROCHLORIDE (2000008529)
PROGESTERONE (1000009777)
FRUCTOSE (1000002379)
ZINC OXIDE (2000008399)
TRICHLOROACETIC ACID (1000007071)
DISODIUM PHOSPHATE ANHYDROUS (3000006909)
THEOPHYLLINE MONOHYDRATE (4000006918)
AZATHIOPRINE (1000009761)
DITHRANOL (1000002937)
COCAINE HYDROCHLORIDE (2000007943)
HYDROQUINONE (1000008752)
CALCIUM CHLORIDE DIHYDRATE (4000009373)
URIDINE (1000006884)
EOSIN (1000005976)
POTASSIUM IODIDE (1000009810)
GALACTOSE (1000008044)
CLOBETASONE BUTYRATE (2000008013)
HYOSCINE BUTYLBROMIDE (2000007324)
LACTOSE (1000008197)
AMMONIUM CHLORIDE (1000008021)
PERMETHRIN (1000009478)
BORAX (1000007346)
FUROSEMIDE (3000005943)
SALICYLIC ACID (1000009710)
VANCOMYCIN HYDROCHLORIDE (2000008485)
HYDROXYETHYLCELLULOSE (1000008666)
TOPIRAMATE (1000002932)
CARBAMAZEPINE (1000006757)
DISODIUM PHOSPHATE DIHYDRATE (3000014468)
EXEMESTANE (1000000183)
GABAPENTIN (1000007380)
WHITE SOFT PARAFFIN (4000006817)
HYOSCINE HYDROBROMIDE (2000007323)
BETAMETHASONE VALERATE (2000008358)
BENZOCAINE (1000009160)
TESTOSTERONE MICRONISED (2000018723)
AMISULPRIDE (1000003074)
PROFLAVINE HEMISULPHATE (2000007900)
L-GLUTATHIONE REDUCED (3000024400)
PHENOL CRYSTALS (3000020190)
TETRACAINE (1000012475)
MINOCYCLINE HYDROCHLORIDE (2000008251)
KETOPROFEN (1000008346)
BUPIVACAINE HYDROCHLORIDE (2000008278)
QUININE HYDROCHLORIDE (2000007815)
DIMETHICONE 350 (4000009591)
CLOZAPINE (1000009115)
SPIRONOLACTONE MICRONISED (2000018722)
MACROGOL 1500 (1000008431)
CAPSAICIN (1000006807)
COPPER SULPHATE (2000007927)
METOPROLOL TARTRATE (2000008259)
MIDAZOLAM HYDROCHLORIDE (2000008252)
MAGNESIUM OXIDE (1000000883)
AMITRIPTYLINE HYDROCHLORIDE (2000008522)
PARACETAMOL (1000009609)
KETAMINE HYDROCHLORIDE (2000008609)
DIMETHYL SULFOXIDE (3000005283)
QUININE DIHYDROCHLORIDE (2000007816)
ERGOCALCIFEROL (2000007667)
ACETYLCYSTEINE (1000009816)
CANNABIDIOL (1000000540)
LEVOMENTHOL NATURAL (3000003005)
TOCOPHERYL ACETATE (4000010502)
CHLORHEXIDINE DIACETATE (4000007351)
CHLORHEXIDINE ACETATE (2000008103)
NEOMYCIN SULPHATE MICRONISED (2000018721)
BETAMETHASONE DIPROPIONATE (2000008360)
MELATONIN (1000000731)
GLYCOPYRRONIUM BROMIDE (2000011773)
BENZOYL PEROXIDE (1000009105)
DILTIAZEM HYDROCHLORIDE (2000007763)
HISTIDINE (1000008814)
CLIOQUINOL (1000004182)
BISACODYL (1000007386)
BENZALKONIUM CHLORIDE SOLUTION 50% (4000007313)
BENDROFLUMETHIAZIDE (3000006463)
COCONUT OIL (2000007942)
LANSOPRAZOLE (1000007341)
ALUMINIUM OXIDE HYDRATED (3000010996)
L-ARGININE (3000004673)
DEXAMETHASONE (1000003334)
NYSTATIN (1000009661)
AMIODARONE HYDROCHLORIDE (2000008524)
BACLOFEN (1000009324)
NORADRENALINE TARTRATE (4000003578)
LIOTHYRONINE SODIUM (2000008504)
MAGNESIUM CARBONATE HEAVY (2000008430)
DIAZEPAM (1000003208)
CLONIDINE HYDROCHLORIDE (2000008010)
LOPERAMIDE HYDROCHLORIDE (2000008494)
ADRENALINE TARTRATE (4000006411)
CHLOROBUTANOL HEMIHYDRATE (2000011272)
CLOBAZAM (1000004171)
TRIAMCINOLONE MICRONISED (2000018724)
ICHTHAMMOL (1000008905)
PHENYLEPHRINE HYDROCHLORIDE (2000008067)
ZINC PYRITHIONE (4000008930)
MEXILETINE HYDROCHLORIDE (2000008257)
METRONIDAZOLE (1000001131)
OXYTOCIN (1000009622)
BECLOMETASONE DIPROPIONATE (4000006191)
PEPPERMINT OIL (4000010071)
MAGNESIUM CHLORIDE HEXAHYDRATE (4000009913)
BENZOIC ACID (1000009143)
CHLORAMPHENICOL MICRONISED (3000020176)
CHLORAL HYDRATE (1000005193)
SODIUM BENZOATE (2000013061)
OMEPRAZOLE (1000009101)
PREDNISONE (1000009793)
CLINDAMYCIN HYDROCHLORIDE (2000006497)
ENALAPRIL MALEATE (2000007672)
LATANOPROST (1000003257)
THYROID (1000007072)
AZITHROMYCIN (1000009476)
LEVOTHYROXINE SODIUM (2000013292)
CLOMIPRAMINE HYDROCHLORIDE (2000008121)
PHENOXYETHANOL (1000009898)
POTASSIUM CHLORIDE (1000009818)
MAGNESIUM STEARATE (1000008714)
AMANTADINE HYDROCHLORIDE (2000008533)
PRASTERONE (1000006301)
NITRAZEPAM (1000009676)
FINASTERIDE (1000007415)
CAFFEINE (1000007507)
L-ARGININE HYDROCHLORIDE (4000006512)
SIMVASTATIN (1000009116)
CINNARIZINE (1000004760)
CAPTOPRIL (1000006787)
DEFEROXAMINE MESYLATE (4000006726)
MAGNESIUM GLYCEROPHOSPHATE (2000012211)
TETRACYCLINE HYDROCHLORIDE (2000007377)
CETRIMIDE (1000006286)
METHENAMINE (1000000630)
BISMUTH SUBGALLATE (2000008349)
TACROLIMUS (1000002882)
GLUCOSE ANHYDROUS (4000009250)
GENTAMICIN SULFATE (4000011668)
PAPAVERINE HYDROCHLORIDE (2000008091)
ATROPINE SULPHATE (2000008446)
CALCIUM CARBONATE HEAVY (4000007498)
PHENOL (1000009902)
GLUCOSE MONOHYDRATE (4000006254)
DIMETHICONE 1000 (4000009592)
PHENYTOIN (1000009887)
CHLORHEXIDINE DIGLUCONATE SOLUTION 20% (4000003169)
KETOCONAZOLE (1000008441)
MACROGOL 4000 (2000012180)
CLOTRIMAZOLE (1000003999)
CYPROTERONE ACETATE (2000007860)
PROPRANOLOL HYDROCHLORIDE (2000007892)
ZINC GLUCONATE (2000005863)
MEBEVERINE HYDROCHLORIDE (2000008414)
YELLOW SOFT PARAFFIN (4000006813)
POTASSIUM DIHYDROGEN PHOSPHATE (4000011338)
FOLIC ACID (1000001996)
HYDROXOCOBALAMIN CHLORIDE (4000010981)
SODIUM DIHYDROGEN PHOSPHATE (3000010117)
DISODIUM PHOSPHATE DODECAHYDRATE (3000014453)
FLUOXETINE HYDROCHLORIDE (2000008390)
CHLORHEXIDINE HYDROCHLORIDE (2000008100)
CETIRIZINE DIHYDROCHLORIDE (4000006373)
TRANEXAMIC ACID (1000009308)
L-METHIONINE (3000004549)
LEVOMEPROMAZINE MALEATE (2000012271)
VITAMIN A PALMITATE (4000006828)
BUMETANIDE (1000007192)
UREA (1000009262)
HYDROXYZINE HYDROCHLORIDE (2000007325)
DISODIUM EDETATE (2000007753)
DIAZOXIDE (1000003204)
DICLOFENAC SODIUM (2000007774)
HYDROCORTISONE ACETATE (2000007338)
CAMPHOR RACEMIC (4000000347)
ENCLOMIPHENE CITRATE (2000022138)
IVERMECTIN (1000001158)
TRIAMCINOLONE ACETONIDE (2000008586)
SULPHUR (1000009383)
MAGNESIUM SULPHATE HEPTAHYDRATE (4000009924)
FLUORESCEIN SODIUM (2000007506)
METFORMIN HYDROCHLORIDE (2000008338)
NITROFURANTOIN (1000009675)
ACETYLSALICYLIC ACID (3000006351)
CHLORPHENIRAMINE MALEATE (2000008095)
AMLODIPINE BESILATE (2000015864)
CHLORHEXIDINE GLUCONATE SOLUTION 20% (4000003482)
PHENOBARBITAL (1000014071)
TROMETAMOL (1000009280)
VERAPAMIL HYDROCHLORIDE (2000008484)
BORIC ACID (1000007337)
CYANOCOBALAMIN (4000010977)
CALCIUM HYDROGEN PHOSPHATE (2000008265)
NADOLOL (1000000391)
CITRIC ACID MONOHYDRATE (2000008022)
BENZALKONIUM CHLORIDE (2000010983)
TADALAFIL (1000000162)
ESTRADIOL BENZOATE (2000016107)
WARFARIN SODIUM (2000008471)
ESTRADIOL (17-ALPHA) (3000021667)
SUCRALFATE (1000009411)
OXYBUTYNIN HYDROCHLORIDE (2000008318)
CHLOROFORM (1000004649)
MICONAZOLE (1000001002)
HYDROCORTISONE (1000008762)
ESTRADIOL (1000017043)
DAPSONE (1000003787)
AZELAIC ACID (1000007411)
TROMETAMOL HYDROCHLORIDE (2000003893)
POTASSIUM CITRATE (1000009817)
ADAPALENE (1000002293)
QUININE SULFATE (4000007240)
GLYCEROL MONOSTEARATE (3000001363)
CALCIUM LACTATE PENTAHYDRATE (4000009405)
PYRIDOXINE HYDROCHLORIDE (4000010966)
MANNITOL (1000000458)
PREDNISOLONE SODIUM PHOSPHATE (2000007914)
TOCOFERSOLAN (4000012967)
DL-ALPHA TOCOPHEROL (4000011023)
CLOBETASOL 17-PROPIONATE (4000007268)
GRISEOFULVIN (1000001953)
TESTOSTERONE PROPIONATE (2000007380)
ALLANTOIN (1000004055)
SODIUM THIOSULPHATE (1000007419)
RIBOFLAVIN SODIUM PHOSPHATE (4000007238)
MINOXIDIL (1000000832)
PHENOBARBITAL SODIUM (2000008072)
AMOXICILLIN (3000006129)
TOBRAMYCIN SULPHATE (2000008597)
PREDNISOLONE (1000009794)
HYDROCORTISONE BUTYRATE (2000007337)
SODIUM CITRATE (1000009535)
CIPROFLOXACIN HYDROCHLORIDE (2000008038)
DEXTROMETHORPHAN HYDROBROMIDE (2000007835)
METHYL SALICYLATE (1000000149)
DOXYCYCLINE HYCLATE (4000006937)
GLUCOSE (1000012489)
L-CITRULLINE (3000016930)
SODIUM CHLORIDE (1000009536)
ISONIAZID (1000007745)
THEOPHYLLINE (1000009347)
BUDESONIDE (1000007214)
POVIDONE-IODINE (1000009800)
SODIUM BICARBONATE (1000009540)
OXETACAINE (3000004664)
MAGNESIUM TRISILICATE (1000000774)
METHIONINE (1000000542)
CAFFEINE CITRATE (2000008271)
FERRIC CHLORIDE HEXAHYDRATE (4000004546)
LACTIC ACID (1000008218)
CHOLECALCIFEROL (2000008032)
CHOLESTEROL (1000004479)
CLOPIDOGREL BISULFATE (4000011216)
MACROGOL 400 (1000008642)
TRETINOIN (1000009303)
CALCIUM CARBONATE LIGHT (2000006127)
CALAMINE (1000007496)
ALLOPURINOL (1000003843)
ALMOND OIL (4000010203)
CITRIC ACID ANHYDROUS (3000004479)
ACETAZOLAMIDE (1000002240)
QUINIDINE SULPHATE (2000007818)
ESTRADIOL HEMIHYDRATE (2000016108)
DUTASTERIDE (1000007791)
LEVOMENTHOL SYNTHETIC (3000003004)
TRYPTOPHAN (1000009274)
NICOTINAMIDE (2000012339)
NEOMYCIN SULPHATE (2000008175)
MICONAZOLE NITRATE (2000008254)
MACROGOL 6000 (3000003702)
FLUOCINOLONE ACETONIDE (2000007511)
ESTRIOL (3000004591)
L-CARNITINE (3000007571)
PREGNENOLONE (1000011186)