Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 8931 Insp GMP 8931/646098-0006 [V]

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

Part 1
Issued following an inspection in accordance with :

Regulation 5 of the current Veterinary Medicines Regulations

  The competent authority of United Kingdom confirms the following :
The Manufacturer : DR REDDY'S LABORATORIES (EU) LIMITED
 
Site address : DR REDDY'S LABORATORIES (EU) LIMITED, STEANARD LANE, MIRFIELD, WF14 8HZ, UNITED KINGDOM
 

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 22/10/2019, 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
Veterinary Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

  • [1000000660] TRAVOPROST
  • [2000017045] PERMETHRIN MEDICAL GRADE VETERINARY CIS:TRANS 25:75
  • [4000007597] PERMETHRIN MEDICAL GRADE CIS/TRANS ISOMERS 25/75
  • [1000010532] TREPROSTINIL
  • [1000012358] LUBIPROSTONE
  • [2000017046] PERMETHRIN MEDICAL GRADE VETERINARY CIS:TRANS 40:60
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
TRAVOPROST
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
chromatography, crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
desolvation (the API is a liquid)
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

PERMETHRIN MEDICAL GRADE VETERINARY CIS:TRANS 25:75
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.5General Finishing Steps
3.5.2  Primary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

PERMETHRIN MEDICAL GRADE CIS/TRANS ISOMERS 25/75
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
desolvation (the API is a liquid)
3.5.2  Primary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

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

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
chromatography, crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
desolvation (the API is a liquid)
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

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

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
drying
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

PERMETHRIN MEDICAL GRADE VETERINARY CIS:TRANS 40:60
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.5General Finishing Steps
3.5.2  Primary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

Contact Details
08/11/2019 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential