Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 58839 |
|---|---|
| 2: Name of authorisation holder | ZYDUS PHARMACEUTICALS UK LTD |
| 3: Address(es) of manufacturing site(s) |
ZYDUS PHARMACEUTICALS UK LIMITED, OFFICE 1, OLD ART COLLEGE, 12 FREDERICK STREET, LOUGHBOROUGH, LE11 3BJ, UNITED KINGDOM ZYDUS PHARMACEUTICALS UK LIMITED, OFFICE ZPUK,SANDRETTO BUILDING, CAVALRY HILL INDUSTRIAL PARK, WEEDON, NORTHAMPTON, NN7 4PP, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ZYDUS PHARMACEUTICALS UK LTD, 1ST FLOOR, TEMPLEBACK, 10 TEMPLE BACK, BRISTOL, BS1 6FL, 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 | 08/10/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ZYDUS PHARMACEUTICALS UK LIMITED, OFFICE 1, OLD ART COLLEGE, 12 FREDERICK STREET, LOUGHBOROUGH, LE11 3BJ, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ZYDUS PHARMACEUTICALS UK LIMITED, OFFICE ZPUK,SANDRETTO BUILDING, CAVALRY HILL INDUSTRIAL PARK, WEEDON, NORTHAMPTON, NN7 4PP, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |