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 10592 |
| 2. Name or corporate name of registrant | SMITHKLINE BEECHAM LIMITED |
| 3. Permanent or legal address of registrant | SMITHKLINE BEECHAM LIMITED, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, SHEWALTON ROAD, IRVINE, KA11 5AP, UNITED KINGDOM SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, CLARENDON ROAD, WORTHING, BN14 8QH, 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 | 25/05/2023 |
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
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, SHEWALTON ROAD, IRVINE, KA11 5AP, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.7 Other
classical fermentation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Extraction, crystallisation, blending | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| AMOXICILLIN TRIHYDRATE (4000006303) | CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, TOANSA, BHAI MOHAN SINGH NAGAR, TOANSA, NAWANSHAHR, PUNJAB, IN-144 533, INDIA BEECHAM PHARMACEUTICALS (PTE) LIMITED, 38 QUALITY ROAD, JURONG INDUSTRIAL ESTATE, Data Not Available, SGP- 618 809, SINGAPORE |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| AMOXICILLIN TRIHYDRATE (4000006303) | |||
| POTASSIUM CLAVULANATE DILUTED (4000012986) | |||
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, CLARENDON ROAD, WORTHING, BN14 8QH, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| AMOXICILLIN TRIHYDRATE (4000006303) | BEECHAM PHARMACEUTICALS (PTE) LIMITED, 38 QUALITY ROAD, JURONG INDUSTRIAL ESTATE, Data Not Available, SGP- 618 809, SINGAPORE CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED, TOANSA, BHAI MOHAN SINGH NAGAR, TOANSA, NAWANSHAHR, PUNJAB, IN-144 533, INDIA |
||
| POTASSIUM CLAVULANATE DILUTED (4000012986) | CKD BIO CORPORATION, 454-486 MOKNAE-DONG, ANSAN-SI, KYUNGGI-DO, Data Not Available, SOUTH KOREA |
||