Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK ManA 37071
2: Name of authorisation holder PIRAMAL CRITICAL CARE LIMITED
3: Address(es) of manufacturing site(s)

PIRAMAL CRITICAL CARE LIMITED, SUITE 4, GROUND FLOOR, HEATHROW BOULEVARD, EAST WING, 280 BATH ROAD, WEST DRAYTON, UB7 0DQ, UNITED KINGDOM

4: Legally registered address of authorisation holder PIRAMAL CRITICAL CARE LIMITED, SUITE 4, GROUND FLOOR, HEATHROW BOULEVARD, EAST WING, 280 BATH ROAD, WEST DRAYTON, UB7 0DQ, 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 25/03/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

PIRAMAL CRITICAL CARE LIMITED, SUITE 4, GROUND FLOOR, HEATHROW BOULEVARD, EAST WING, 280 BATH ROAD, WEST DRAYTON, UB7 0DQ, UNITED KINGDOM

Veterinary Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
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. 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