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 43080 |
| 2. Name or corporate name of registrant | LAKE CHEMICALS AND MINERALS LIMITED |
| 3. Permanent or legal address of registrant | LAKE CHEMICALS AND MINERALS LIMITED, UNIT 3, MOONS PARK, BURNT MEADOW ROAD, MOONS MOAT NORTH INDUSTRIAL ESTATE, REDDITCH, B98 9PA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
LAKE CHEMICALS AND MINERALS LIMITED, UNIT 10 PADGETS LANE, REDDITCH, B98 0RA, UNITED KINGDOM LAKE CHEMICALS & MINERALS LIMITED, UNIT 3, MOONS PARK, BURNT MEADOW ROAD, MOONS MOAT NORTH INDUSTRIAL ESTATE, REDDITCH, B98 9PA, 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 | 02/01/2024 |
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
LAKE CHEMICALS AND MINERALS LIMITED, UNIT 10 PADGETS LANE, REDDITCH, B98 0RA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| PREDNISOLONE ACETATE (2000007916) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| EXEMESTANE (1000000183) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| BETAMETHASONE SODIUM PHOSPHATE (2000008359) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| TESTOSTERONE PROPIONATE (2000007380) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| CLOBETASOL PROPIONATE (2000008014) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| MOMETASONE FUROATE (2000008125) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PRIVATE LIMITED, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA |
||
| BETAMETHASONE DIPROPIONATE (2000008360) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| TIBOLONE (1000009078) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| NIACINAMIDE (4000009993) | LONZA GUANGZHOU NANSHA LIMITED, SEEBLICKSTRASSE 4, ROMANSHORN, CH-8590, SWITZERLAND |
||
| BETAMETHASONE VALERATE (2000008358) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| PARACETAMOL (1000009609) | FARMASON PHARMACEUTICAL GURARAT PVT. LIMITED, PLOT NO. 28-35 G.I.D.C. INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
||
| ATROPINE SULFATE (4000006648) | SAURAV CHEMICALS LIMITED, UNIT 3, DERABASSI BARWALA ROAD, VILLAGE BHAGWANPURA, SAHIBZADA AJIT SINGH NAGAR, DERABASSI, PUNJAB, IN-140507, INDIA |
||
| MIDAZOLAM MALEATE (2000015392) | LAKE CHEMICALS PVT LIMITED, SITE NO 21M, ATTIBELE INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-562 107, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PREDNISOLONE ACETATE (2000007916) | |||
| EXEMESTANE (1000000183) | |||
| BETAMETHASONE SODIUM PHOSPHATE (2000008359) | |||
| TESTOSTERONE PROPIONATE (2000007380) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | |||
| MOMETASONE FUROATE (2000008125) | |||
| GUAIFENESIN (3000005625) | |||
| BETAMETHASONE DIPROPIONATE (2000008360) | |||
| TIBOLONE (1000009078) | |||
| NIACINAMIDE (4000009993) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| PARACETAMOL (1000009609) | |||
| ATROPINE SULFATE (4000006648) | |||
| MIDAZOLAM MALEATE (2000015392) | |||
LAKE CHEMICALS & MINERALS LIMITED, UNIT 3, MOONS PARK, BURNT MEADOW ROAD, MOONS MOAT NORTH INDUSTRIAL ESTATE, REDDITCH, B98 9PA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| MIDAZOLAM MALEATE (2000015392) | LAKE CHEMICALS PVT LIMITED, SITE NO 21M, ATTIBELE INDUSTRIAL AREA, ANEKAL TALUK, BENGALURU, KARNATAKA, IN-562 107, INDIA |
||
| NIACINAMIDE (4000009993) | LONZA GUANGZHOU NANSHA LIMITED, SEEBLICKSTRASSE 4, ROMANSHORN, CH-8590, SWITZERLAND |
||
| PREDNISOLONE ACETATE (2000007916) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PRIVATE LIMITED, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA SYNTHOKEM LABS PRIVATE LIMITED, UNIT-II, PLOT NO 222-224 & 235-237, PHASE-II, IDA, PATANCHERU MANDAL, SANGAREDDY DISTRICT, PASHAMYLARAM, TELANGANA, IN-502 319, INDIA |
||
| TIBOLONE (1000009078) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| MOMETASONE FUROATE (2000008125) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| ATROPINE SULFATE (4000006648) | SAURAV CHEMICALS LIMITED, UNIT 3, DERABASSI BARWALA ROAD, VILLAGE BHAGWANPURA, SAHIBZADA AJIT SINGH NAGAR, DERABASSI, PUNJAB, IN-140507, INDIA |
SAURAV CHEMICALS LIMITED, UNIT 3, DERABASSI BARWALA ROAD, VILLAGE BHAGWANPURA, SAHIBZADA AJIT SINGH NAGAR, DERABASSI, PUNJAB, IN-140507, INDIA |
|
| PARACETAMOL (1000009609) | FARMASON PHARMACEUTICAL GURARAT PVT. LIMITED, PLOT NO. 28-35 G.I.D.C. INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
||
| TESTOSTERONE PROPIONATE (2000007380) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| BETAMETHASONE DIPROPIONATE (2000008360) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| CLOBETASOL PROPIONATE (2000008014) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| BETAMETHASONE VALERATE (2000008358) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| EXEMESTANE (1000000183) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| BETAMETHASONE SODIUM PHOSPHATE (2000008359) | SYMBIOTICA SPECIALITY INGREDIENTS SDN.BHD, NO. 518 JALAN WAJA 4, WAJA INDUSTRIAL ESTATE, KULIM, KEDAH, MY-09000, MALAYSIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| DEXAMETHASONE SODIUM PHOSPHATE (2000007843) | |||
| MIDAZOLAM MALEATE (2000015392) | |||
| NIACINAMIDE (4000009993) | |||
| PREDNISOLONE ACETATE (2000007916) | |||
| GUAIFENESIN (3000005625) | |||
| TIBOLONE (1000009078) | |||
| MOMETASONE FUROATE (2000008125) | |||
| ATROPINE SULFATE (4000006648) | |||
| PARACETAMOL (1000009609) | |||
| TESTOSTERONE PROPIONATE (2000007380) | |||
| BETAMETHASONE DIPROPIONATE (2000008360) | |||
| CLOBETASOL PROPIONATE (2000008014) | |||
| BETAMETHASONE VALERATE (2000008358) | |||
| EXEMESTANE (1000000183) | |||
| BETAMETHASONE SODIUM PHOSPHATE (2000008359) | |||