Medicines and Healthcare products Regulatory Agency
1: Authorisation Number | UK MIA 43252 |
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2: Name of authorisation holder | ATNAHS PHARMA UK LIMITED |
3: Address(es) of manufacturing site(s) |
ATNAHS PHARMA UK LIMITED, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, UNITED KINGDOM |
4: Legally registered address of authorisation holder | ATNAHS PHARMA UK LIMITED, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, 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 | 30/01/2024 |
9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ATNAHS PHARMA UK LIMITED, SOVEREIGN HOUSE, MILES GRAY ROAD, BASILDON, SS14 3FR, UNITED KINGDOM
Human Medicinal Products
Authorised Operations |
MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
Part 1 - MANUFACTURING OPERATIONS |
[ 1.1 ] Sterile Products |
[ 1.1.3 ] Batch certification |
[ 1.2 ] Non-sterile products |
[ 1.2.2 ] Batch certification |
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
[ 2.2 ] Batch certification of imported medicinal products |
[ 2.2.1 ] Sterile Products |
[ 2.2.1.1 ] Aseptically prepared |
[ 2.2.1.2 ] Terminally sterilised |
[ 2.2.2 ] Non-sterile products |