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 & MINERALS LIMITED, UNIT 3, MOONS PARK, BURNT MEADOW ROAD, MOONS MOAT NORTH INDUSTRIAL ESTATE, REDDITCH, B98 9PA, UNITED KINGDOM LAKE CHEMICALS AND MINERALS LIMITED, UNIT 10 PADGETS LANE, REDDITCH, B98 0RA, 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 | 29/05/2024 |
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 & 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 | |
| CHOLECALCIFEROL (2000008032) | FERMENTA BIOTECH LIMITED, Z-109, B&C, SEZ II, TALUKA VAGARA, DISTRICT BHARUCH, DAHEJ, GUJARAT, IN-392 130, INDIA ZHEJIANG GARDEN, HUAYUAN VILLAGE, NANMA TOWN, DONGYANG, CN-322121, CHINA |
||
| THIAMINE HYDROCHLORIDE (4000010937) | JIANGXI TIANXIN PHARMACEUTICAL COMPANY LIMITED, LE'ANJIANG INDUSTRIAL ZONE, LEPING, ZIANGXI, CN-333300, CHINA |
||
| 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 |
||
| NIACINAMIDE (4000009993) | WESTERN DRUGS LIMITED, F271 (A), MEWAR INDUSTRIAL AREA, MADRI, UDAIPUR, RAJASTHAN, IN 313001, INDIA |
||
| FOLIC ACID (1000001996) | HEBEI JIHENG, NO.1 WEIWU STREET, HENGSHUI INDUSTRIAL PARK, HENGSHUI CITY, HEBEI PROVINCE, CN-053 000, CHINA |
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| ASCORBIC ACID (1000009903) | NINGXIA QIYUAN PHARMACEUTICAL COMPANY LIMITED, NO 1 QIYUAN STEET, WANGYUAN INDUSTRIAL AREA, YINCHUAN, NINGXIA, CN-750101, CHINA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CHOLECALCIFEROL (2000008032) | |||
| THIAMINE HYDROCHLORIDE (4000010937) | |||
| GUAIFENESIN (3000005625) | |||
| NIACINAMIDE (4000009993) | |||
| FOLIC ACID (1000001996) | |||
| ASCORBIC ACID (1000009903) | |||
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 | |
| THIAMINE HYDROCHLORIDE (4000010937) | JIANGXI TIANXIN PHARMACEUTICAL COMPANY LIMITED, LE'ANJIANG INDUSTRIAL ZONE, LEPING, ZIANGXI, CN-333300, CHINA |
||
| ASCORBIC ACID (1000009903) | NINGXIA QIYUAN PHARMACEUTICAL COMPANY LIMITED, NO 1 QIYUAN STEET, WANGYUAN INDUSTRIAL AREA, YINCHUAN, NINGXIA, CN-750101, CHINA |
||
| CHOLECALCIFEROL (2000008032) | FERMENTA BIOTECH LIMITED, Z-109, B&C, SEZ II, TALUKA VAGARA, DISTRICT BHARUCH, DAHEJ, GUJARAT, IN-392 130, INDIA ZHEJIANG GARDEN, HUAYUAN VILLAGE, NANMA TOWN, DONGYANG, CN-322121, CHINA |
||
| FOLIC ACID (1000001996) | HEBEI JIHENG, NO.1 WEIWU STREET, HENGSHUI INDUSTRIAL PARK, HENGSHUI CITY, HEBEI PROVINCE, CN-053 000, CHINA |
||
| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PRIVATE LIMITED, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA |
||
| NIACINAMIDE (4000009993) | WESTERN DRUGS LIMITED, F271 (A), MEWAR INDUSTRIAL AREA, MADRI, UDAIPUR, RAJASTHAN, IN 313001, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| THIAMINE HYDROCHLORIDE (4000010937) | |||
| ASCORBIC ACID (1000009903) | |||
| CHOLECALCIFEROL (2000008032) | |||
| FOLIC ACID (1000001996) | |||
| GUAIFENESIN (3000005625) | |||
| NIACINAMIDE (4000009993) | |||