Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 12862 |
|---|---|
| 2: Name of authorisation holder | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED |
| 3: Address(es) of manufacturing site(s) |
KFM CO-PACKER LIMITED, EAGLE BUSINESS CENTRE, 49 CLEVELAND STREET, HULL, HU8 7AU, UNITED KINGDOM RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, UNITED KINGDOM PHARMAPAC (UK) LIMITED, UNITS 20 TO 24 AND 29 AND 30, VALLEY ROAD BUSINESS PARK, BIRKENHEAD, CH41 7EL, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, 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 | 13/12/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
KFM CO-PACKER LIMITED, EAGLE BUSINESS CENTRE, 49 CLEVELAND STREET, HULL, HU8 7AU, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.1 ] Large volume liquids |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.17 ] Other non-sterile medicinal products Medicated Lozenges |
| [ 1.2.2 ] Batch certification |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.17 ] Other non-sterile medicinal products Solid non-sterile unit dosage forms: capsules. Medicated Lozenges |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 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 |
| [ 2.2.2 ] Non-sterile products |
PHARMAPAC (UK) LIMITED, UNITS 20 TO 24 AND 29 AND 30, VALLEY ROAD BUSINESS PARK, BIRKENHEAD, CH41 7EL, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.2 ] Secondary packaging |