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 | 16/04/2024 |
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 | |
| TOPIRAMATE (1000002932) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| EPINASTINE HYDROCHLORIDE (2000006570) | 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 |
||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | 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 |
||
| CLOMIFENE CITRATE (4000007266) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, 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 |
||
| MESALAMINE (3000003546) | 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 |
||
| 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 421501, INDIA |
||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| TOLTERODINE TARTRATE (2000013355) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| DAPSONE (1000003787) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
||
| HYDROQUINONE (1000008752) | 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 |
||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | BAJAJ HEALTHCARE LIMITED (UNIT-2), UNIT II, BLOCK NO 588, SAVLI-KARACHIA ROAD, SAVLI, VANDODARA, GOTHADA, GUJARAT, IN-391776, INDIA |
||
| ADAPALENE (1000002293) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| MESALAZINE (1000000859) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, 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 |
||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | DIVIS LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, 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 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 |
||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| AMYLMETACRESOL (1000000573) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, INDIA |
||
| METFORMIN HYDROCHLORIDE (2000008338) | HARMAN FINOCHEM LIMITED, PLOT NO. E-7, E-8, E-9, MIDC INDUSTRIAL AREA, CHIKALTHANA, AURANGABAD, MAHARASHTRA, IN-431006, INDIA HARMAN FINOCHEM LIMITED, PLOT NO. A-100, A-100-1, A-100-2, D-1, MIDC INDUSTRIAL AREA, SHENDRA, AURANGABAD, MAHARASHTRA, IN-431007, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TOPIRAMATE (1000002932) | |||
| EPINASTINE HYDROCHLORIDE (2000006570) | |||
| AMILORIDE HYDROCHLORIDE (2000008529) | |||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | |||
| BACLOFEN (1000009324) | |||
| CLOMIFENE CITRATE (4000007266) | |||
| TORSEMIDE ANHYDROUS (3000020810) | |||
| MESALAMINE (3000003546) | |||
| GLICLAZIDE (1000001769) | |||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | |||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | |||
| TOLTERODINE TARTRATE (2000013355) | |||
| DAPSONE (1000003787) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| HYDROQUINONE (1000008752) | |||
| TRANEXAMIC ACID (1000009308) | |||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | |||
| ADAPALENE (1000002293) | |||
| MESALAZINE (1000000859) | |||
| BISOPROLOL FUMARATE (2000008290) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | |||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | |||
| KETOPROFEN (1000008346) | |||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | |||
| AMYLMETACRESOL (1000000573) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
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 | |
| 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 |
||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | 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 |
||
| HYDROQUINONE (1000008752) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, INDIA |
||
| MESALAMINE (3000003546) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, INDIA |
||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | ANDHRA MEDIPHARMA INDIA PVT. LIMITED., SURVEY NO. 263, VEERAVALLI VILLAGE, BAPULAPADU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH, IN 521110, INDIA |
||
| TOLTERODINE TARTRATE (2000013355) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | DIVIS LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, 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 |
||
| ADAPALENE (1000002293) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| METFORMIN HYDROCHLORIDE (2000008338) | HARMAN FINOCHEM LIMITED, PLOT NO. A-100, A-100-1, A-100-2, D-1, MIDC INDUSTRIAL AREA, SHENDRA, AURANGABAD, MAHARASHTRA, IN-431007, INDIA HARMAN FINOCHEM LIMITED, PLOT NO. E-7, E-8, E-9, MIDC INDUSTRIAL AREA, CHIKALTHANA, AURANGABAD, MAHARASHTRA, IN-431006, INDIA |
||
| KETOPROFEN (1000008346) | BEC CHEMICALS PVT.LTD, PLOT NO 24, MIDC DHATAV ROHA, RAIGAD DISTRICT, RAIGAD, MAHARASHTRA, IN-402 116, 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 |
||
| CLOMIFENE CITRATE (4000007266) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, 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 421501, INDIA |
||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, 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 |
||
| AMILORIDE HYDROCHLORIDE (2000008529) | 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 |
||
| MESALAZINE (1000000859) | 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 |
||
| EPINASTINE HYDROCHLORIDE (2000006570) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, 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 |
||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | BAL PHARMA LIMITED, UNIT II, 61-B BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-560099, INDIA |
||
| DAPSONE (1000003787) | MEDILUX LABORATORIES PVT. LIMITED., PLOT NO. 98-99, SECTOR-I, INDUSTRIAL AREA DHAR DISTRICT, PITHAMPUR, MADHYA PRADESH, IN-454 775, 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 |
||
| AMYLMETACRESOL (1000000573) | BIOXERA PHARMA PVT. LIMITED., PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TRANEXAMIC ACID (1000009308) | |||
| BENZYDAMINE HYDROCHLORIDE (2000008364) | |||
| BACLOFEN (1000009324) | |||
| HYDROQUINONE (1000008752) | |||
| MESALAMINE (3000003546) | |||
| GLUCOSAMINE HYDROCHLORIDE (2000008777) | |||
| TOLTERODINE TARTRATE (2000013355) | |||
| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | |||
| CHLORHEXIDINE GLUCONATE SOLUTION (4000009485) | |||
| ADAPALENE (1000002293) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| KETOPROFEN (1000008346) | |||
| GLUCOSAMINE SULPHATE SODIUM CHLORIDE (2000009013) | |||
| CLOMIFENE CITRATE (4000007266) | |||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (4000011670) | |||
| AMILORIDE HYDROCHLORIDE (2000008529) | |||
| GLICLAZIDE (1000001769) | |||
| MESALAZINE (1000000859) | |||
| TOPIRAMATE (1000002932) | |||
| EPINASTINE HYDROCHLORIDE (2000006570) | |||
| TORSEMIDE ANHYDROUS (3000020810) | |||
| AMILORIDE HYDROCHLORIDE DIHYDRATE (4000006310) | |||
| DAPSONE (1000003787) | |||
| BISOPROLOL FUMARATE (2000008290) | |||
| AMYLMETACRESOL (1000000573) | |||