Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 58839 |
| 2. Name of Authorisation Holder | ZYDUS PHARMACEUTICALS UK LTD |
| 3. Legally registered address of Authorisation Holder | ZYDUS PHARMACEUTICALS UK LTD, 1ST FLOOR, TEMPLEBACK, 10 TEMPLE BACK, BRISTOL, BS1 6FL, UNITED KINGDOM |
| 4. Address(es) of 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 |
| 5. Scope of authorisation (complete for each site under 4) | ANNEX 1 |
| 6. Legal basis of authorisation | Regulation 18 of the Human Medicines Regulations 2012 |
| 7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation | Confidential |
| 8. Date | 20/09/2024 |
| 9. Annexes attached | Annex 1 Scope of wholesale distribution authorisation
Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number
Annex 3 (Optional) Name(s) of responsible person(s)
Annex 4 (Optional) Date of Inspection on which authorisation was granted
Annex 5 Additional provisions |
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
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.3 Supply |
| 2.4 Export |
| 2.6 Products imported from countries on a list |
| 2.6a Products certified under Article 51 of Directive 2001/83/EC |
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines, 4.2 General Sales List, 4.4 Pharmacy
Name and address of the site:
ZYDUS PHARMACEUTICALS UK LIMITED, OFFICE ZPUK,SANDRETTO BUILDING, CAVALRY HILL INDUSTRIAL PARK, WEEDON, NORTHAMPTON, NN7 4PP, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.3 Supply |
| 2.4 Export |
| 2.6 Products imported from countries on a list |
| 2.6a Products certified under Article 51 of Directive 2001/83/EC |
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines, 4.2 General Sales List, 4.4 Pharmacy