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 11717 |
| 2. Name or corporate name of registrant | SURFACHEM LIMITED |
| 3. Permanent or legal address of registrant | SURFACHEM LIMITED, 2 THE EMBANKMENT, SOVEREIGN STREET, LEEDS, LS1 4BA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
SURFACHEM LIMITED, 2 THE EMBANKMENT, SOVEREIGN STREET, LEEDS, LS1 4BA, UNITED KINGDOM SURFACHEM LIMITED, THE AINLEYS, HUDDERSFIELD ROAD, ELLAND, HX5 9JR, 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 | 15/04/2025 |
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
SURFACHEM LIMITED, 2 THE EMBANKMENT, SOVEREIGN STREET, LEEDS, LS1 4BA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| METFORMIN HYDROCHLORIDE (2000008338) | HARMAN FINOCHEM LIMITED, PLOT NUMBERS A-100, A-100/1, A-100/2, A-120 AND D-1, M.I.D.C. INDUSTRIAL AREA, SHENDRA, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431154, INDIA HARMAN FINOCHEM LIMITED, PLOT NUMBERS E-7, E-8, E-9 & E-53, M.I.D.C. INDUSTRIAL AREA, CHIKALTHANA, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431006, INDIA |
||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| MESALAZINE (1000000859) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| EPINASTINE HYDROCHLORIDE (2000006570) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| GLICLAZIDE (1000001769) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| ADAPALENE (1000002293) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| BISOPROLOL FUMARATE (2000008290) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| HYDROQUINONE (1000008752) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| DAPSONE (1000003787) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| TORSEMIDE ANHYDROUS (3000020810) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| 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 |
||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | DIVIS LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
||
| AMYLMETACRESOL (1000000573) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| MESALAMINE (3000003546) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| KETOPROFEN (1000008346) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| CLOMIFENE CITRATE (4000007266) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
||
| AMILORIDE HYDROCHLORIDE (2000008529) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| BACLOFEN (1000009324) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| TOLTERODINE TARTRATE (2000013355) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| TOPIRAMATE (1000002932) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | BAJAJ HEALTHCARE LIMITED (UNIT-2), UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, INDIA |
||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | |||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | |||
| MESALAZINE (1000000859) | |||
| EPINASTINE HYDROCHLORIDE (2000006570) | |||
| GLICLAZIDE (1000001769) | |||
| ADAPALENE (1000002293) | |||
| BISOPROLOL FUMARATE (2000008290) | |||
| HYDROQUINONE (1000008752) | |||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | |||
| DAPSONE (1000003787) | |||
| TORSEMIDE ANHYDROUS (3000020810) | |||
| TRANEXAMIC ACID (1000009308) | |||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | |||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| AMYLMETACRESOL (1000000573) | |||
| MESALAMINE (3000003546) | |||
| KETOPROFEN (1000008346) | |||
| CLOMIFENE CITRATE (4000007266) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| AMILORIDE HYDROCHLORIDE (2000008529) | |||
| BACLOFEN (1000009324) | |||
| TOLTERODINE TARTRATE (2000013355) | |||
| TOPIRAMATE (1000002932) | |||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | |||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | |||
SURFACHEM LIMITED, THE AINLEYS, HUDDERSFIELD ROAD, ELLAND, HX5 9JR, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| TOLTERODINE TARTRATE (2000013355) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| METFORMIN HYDROCHLORIDE (2000008338) | HARMAN FINOCHEM LIMITED, PLOT NUMBERS E-7, E-8, E-9 & E-53, M.I.D.C. INDUSTRIAL AREA, CHIKALTHANA, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431006, INDIA HARMAN FINOCHEM LIMITED, PLOT NUMBERS A-100, A-100/1, A-100/2, A-120 AND D-1, M.I.D.C. INDUSTRIAL AREA, SHENDRA, CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA, IN-431154, INDIA |
||
| DAPSONE (1000003787) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| MESALAZINE (1000000859) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| GLICLAZIDE (1000001769) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| 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 |
||
| TORSEMIDE ANHYDROUS (3000020810) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| ADAPALENE (1000002293) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| AMILORIDE HYDROCHLORIDE (2000008529) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
||
| AMYLMETACRESOL (1000000573) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| HYDROQUINONE (1000008752) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| BACLOFEN (1000009324) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | DIVIS LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
||
| MESALAMINE (3000003546) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| TOPIRAMATE (1000002932) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| KETOPROFEN (1000008346) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | BAJAJ HEALTHCARE LIMITED (UNIT-2), UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, INDIA |
||
| BISOPROLOL FUMARATE (2000008290) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| CLOMIFENE CITRATE (4000007266) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421506, INDIA |
||
| EPINASTINE HYDROCHLORIDE (2000006570) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TOLTERODINE TARTRATE (2000013355) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| DAPSONE (1000003787) | |||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | |||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | |||
| MESALAZINE (1000000859) | |||
| GLICLAZIDE (1000001769) | |||
| TRANEXAMIC ACID (1000009308) | |||
| TORSEMIDE ANHYDROUS (3000020810) | |||
| ADAPALENE (1000002293) | |||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | |||
| AMILORIDE HYDROCHLORIDE (2000008529) | |||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| AMYLMETACRESOL (1000000573) | |||
| HYDROQUINONE (1000008752) | |||
| BACLOFEN (1000009324) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| MESALAMINE (3000003546) | |||
| TOPIRAMATE (1000002932) | |||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | |||
| KETOPROFEN (1000008346) | |||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | |||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | |||
| BISOPROLOL FUMARATE (2000008290) | |||
| CLOMIFENE CITRATE (4000007266) | |||
| EPINASTINE HYDROCHLORIDE (2000006570) | |||