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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 39359 Insp GMP 39359/2460457-0001 [H]

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1
Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : SHANGHAI DESANO CHEMICAL PHARMACEUTICAL COMPANY LIMITED
 
Site address : SHANGHAI DESANO CHEMICAL PHARMACEUTICAL COMPANY LIMITED , 417 BINHAI ROAD, LAOGANG TOWN, PUDONG NEW AREA, SHANGHAI, CN 201302, CHINA
 

Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).

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 of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)

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.
Part 2
Human Medicinal Products

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
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

ATAZANAVIR
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

TENOFOVIR DISOPROXIL FUMARATE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

EMTRICITABINE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

RITONAVIR
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

EFAVIRENZ
3.6Quality Control Testing
3.6.1  Physical / Chemical testing

ARTEMETHER
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

ZIDOVUDINE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

NEVIRAPINE ANHYDROUS
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

LUMEFANTRINE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

STAVUDINE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

DOLUTEGRAVIR SODIUM
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

LAMIVUDINE ANHYDROUS
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.6Quality 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

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