Medicines and Healthcare products Regulatory Agency
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Regulation 5 of the current Veterinary Medicines Regulations
The competent authority of United Kingdom confirms the following :Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with API-A80(1)-D2001/82/EC Regulation 5 of The current Veterinary Medicines Regulations
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 06/03/2017, it is considered that it complies with
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation 5 of the current Veterinary Medicines Regulations
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.
- (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
- (2) These requirements fulfil the GMP recommendations of WHO.
Manufacture of active substance. Names of substances subject to inspection:
- [1000015572] PRAZIQUANTEL
- [1000000759] ATAZANAVIR
- [2000005915] TENOFOVIR DISOPROXIL FUMARATE
- [1000000548] EMTRICITABINE
- [1000007738] RITONAVIR
- [1000000060] EFAVIRENZ
- [1000007923] ARTEMETHER
- [1000009208] ZIDOVUDINE
- [3000008302] NEVIRAPINE ANHYDROUS
- [1000000058] LUMEFANTRINE
- [1000002482] STAVUDINE
- [2000017895] DOLUTEGRAVIR SODIUM
- [3000019013] LAMIVUDINE ANHYDROUS
| 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES | |
| PRAZIQUANTEL | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ATAZANAVIR | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| TENOFOVIR DISOPROXIL FUMARATE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| EMTRICITABINE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| RITONAVIR | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| EFAVIRENZ | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ARTEMETHER | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ZIDOVUDINE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| NEVIRAPINE ANHYDROUS | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| LUMEFANTRINE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| STAVUDINE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| DOLUTEGRAVIR SODIUM | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| LAMIVUDINE ANHYDROUS | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| 15/06/2017 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |