Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 29595 |
|---|---|
| 2: Name of authorisation holder | PIRAMAL HEALTHCARE UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
PIRAMAL HEALTHCARE UK LIMITED, EARLS ROAD, GRANGEMOUTH, FK3 8XG, UNITED KINGDOM PIRAMAL HEALTHCARE UK LIMITED , WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, UNITED KINGDOM PIRAMAL HEALTHCARE UK LIMITED, 2 ROSELAND HALL, EARLS GATE PARK, GRANGEMOUTH, FK3 8ZF, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | PIRAMAL HEALTHCARE UK LIMITED, WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, 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 | 15/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PIRAMAL HEALTHCARE UK LIMITED, EARLS ROAD, GRANGEMOUTH, FK3 8XG, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.17 ] Other non-sterile medicinal products Liquid conjugate bulk drug substances in solution Special Requirements Including cytotoxic and potent bulk drug substances |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products QP certification of the manufacturing and testing conducted on Liquid conjugate bulk drug substances in solution Special Requirements Including cytotoxic and potent bulk drug substances |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products QP certification of the manufacturing and testing conducted on Liquid conjugate bulk drug substances in solution Special Requirements Including cytotoxic and potent bulk drug substances |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PIRAMAL HEALTHCARE UK LIMITED , WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, 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 |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.5 ] Other terminally sterilised prepared products Secondary Packaging and Batch Certification of terminally sterilised ampoules |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.8 ] Other solid dosage forms Special Requirements Granules with hormonal properties |
| [ 1.2.1.13 ] Tablets Special Requirements Range of hormonal/ hormonal property tablets |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.8 ] Other solid dosage forms Special Requirements Granules with hormonal properties |
| [ 1.5.1.13 ] Tablets Special Requirements Range of hormonal/ hormonal property tablets |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 2.1.3 ] Chemical/Physical |
| [ 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 |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
PIRAMAL HEALTHCARE UK LIMITED, 2 ROSELAND HALL, EARLS GATE PARK, GRANGEMOUTH, FK3 8ZF, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.17 ] Other non-sterile medicinal products Liquid conjugate bulk drug substances in solution Special Requirements Including cytotoxic and potent bulk drug substances |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products QP batch certification of the manufacturing and testing conducted on liquid conjugate bulk drug substances in solution Special Requirements Including cytotoxic and potent bulk drug substances |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |