Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 10592 |
|---|---|
| 2: Name of authorisation holder | SMITHKLINE BEECHAM LIMITED |
| 3: Address(es) of manufacturing site(s) |
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, CLARENDON ROAD, WORTHING, BN14 8QH, UNITED KINGDOM SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, SHEWALTON ROAD, IRVINE, KA11 5AP, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SMITHKLINE BEECHAM LIMITED, 79 NEW OXFORD STREET, LONDON, WC1A 1DG, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 09/08/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, CLARENDON ROAD, WORTHING, BN14 8QH, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.17 ] Other non-sterile medicinal products Including tablets (penicillin), Potassium Clavulanate/Amoxicillin Trihydrate |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.17 ] Other non-sterile medicinal products Tablets (penicillin), Potassium Clavulanate/Amoxicillin Trihydrate |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, SHEWALTON ROAD, IRVINE, KA11 5AP, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.17 ] Other non-sterile medicinal products Active intermediate Potassium Clavulanate/ Amoxicillin Trihydrate 1:1 non sterile mix, Blending of APIs. |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |