Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 50484
2: Name of authorisation holder SYNERGY BIOLOGICS LIMITED
3: Address(es) of manufacturing site(s)

SYNERGY BIOLOGICS LIMITED, UNIT 1, THE STAMP FACTORY, WEDNESBURY ROAD, WALSALL, WS1 3QY, UNITED KINGDOM

4: Legally registered address of authorisation holder SYNERGY BIOLOGICS LIMITED, UNIT 1, THE STAMP FACTORY, WEDNESBURY ROAD, WALSALL, WS1 3QY, 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 17/09/2025
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

SYNERGY BIOLOGICS LIMITED, UNIT 1, THE STAMP FACTORY, WEDNESBURY ROAD, WALSALL, WS1 3QY, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation