Medicines and Healthcare products Regulatory Agency
| 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 | 
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) | 
| 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 | 
