Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 28278
2: Name of authorisation holder IPCA LABORATORIES UK LIMITED
3: Address(es) of manufacturing site(s)

IPCA LABORATORIES UK LIMITED, UNITS 97-98, SILVERBRIAR, SUNDERLAND ENTERPRISE PARK EAST, SUNDERLAND, SR5 2TQ, UNITED KINGDOM

4: Legally registered address of authorisation holder IPCA LABORATORIES UK LIMITED, UNITS 97-98, SILVERBRIAR, SUNDERLAND ENTERPRISE PARK EAST, SUNDERLAND, SR5 2TQ, 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 24/06/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

IPCA LABORATORIES UK LIMITED, UNITS 97-98, SILVERBRIAR, SUNDERLAND ENTERPRISE PARK EAST, SUNDERLAND, SR5 2TQ, 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