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 12052 |
| 2. Name or corporate name of registrant | WHYTE CHEMICALS LIMITED |
| 3. Permanent or legal address of registrant | WHYTE CHEMICALS LIMITED, LINTHWAITE, HUDDERSFIELD, WEST YORKSHIRE, Data Not Available, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
WHYTE CHEMICALS LIMITED, DENABY LANE INDUSTRIAL ESTATE, OLD DENABY, DONCASTER, DN12 4LQ, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 10/04/2018 |
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
WHYTE CHEMICALS LIMITED, DENABY LANE INDUSTRIAL ESTATE, OLD DENABY, DONCASTER, DN12 4LQ, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| VITAMIN A PALMITATE (4000006828) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| CALCIUM ASCORBATE (2000007886) | DSM NUTRITIONAL PRODUCTS, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| DL-ALPHA TOCOPHEROL ACETATE (4000006941) | DSM NUTRITIONAL PRODUCTS, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| NIACINAMIDE (4000009993) | LONZA GUANGZHOU NANSHA LIMITED, 68 HUANGGE DADAOBEI, NANSHA DISTRICT, GUANGZHOU, GUANGDONG PROVINCE, CN-511 455, CHINA |
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| PYRIDOXINE HYDROCHLORIDE (4000010966) | DSM NUTRITIONAL PRODUCTS, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| THIAMINE MONONITRATE (4000006559) | DSM NUTRITIONAL PRODUCTS, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| BETA CAROTENE (1000009455) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| VITAMIN A ACETATE (4000006831) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| CYANOCOBALAMIN (4000010977) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| RIBOFLAVIN (4000010954) | DSM NUTRITIONAL PRODUCTS, 206 MACKS ISLAND DRIVE, BELVIDERE, 07823-1113, UNITED STATES |
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| CHOLECALCIFEROL (2000008032) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PRIVATE LIMITED, PLOT NO 1911, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA |
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| FOLIC ACID (1000001996) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| PHYTOMENADIONE (2000014030) | DSM NUTRITIONAL PRODUCTS LIMITED, HAUPTSTRASSE 4, SISSELN, CH-4332, SWITZERLAND |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| VITAMIN A PALMITATE (4000006828) | |||
| CALCIUM ASCORBATE (2000007886) | |||
| DL-ALPHA TOCOPHEROL ACETATE (4000006941) | |||
| NIACINAMIDE (4000009993) | |||
| PYRIDOXINE HYDROCHLORIDE (4000010966) | |||
| THIAMINE MONONITRATE (4000006559) | |||
| BETA CAROTENE (1000009455) | |||
| VITAMIN A ACETATE (4000006831) | |||
| CYANOCOBALAMIN (4000010977) | |||
| RIBOFLAVIN (4000010954) | |||
| CHOLECALCIFEROL (2000008032) | |||
| GUAIFENESIN (3000005625) | |||
| FOLIC ACID (1000001996) | |||
| PHYTOMENADIONE (2000014030) | |||