Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 21553 Insp GMP 21553/21992-0010 [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 : EMCURE PHARMACEUTICALS LIMITED (OSD AND POTENT INJECTABLES)
 
Site address : EMCURE PHARMACEUTICALS LIMITED (OSD AND POTENT INJECTABLES), PLOT NO.P-2, IT PARK, PHASE II MIDC, HINJWADI, PUNE, IN-411 057, INDIA
 

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area 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 14/03/2016, it is considered that it complies with

  • The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)

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
Operations
  1. MANUFACTURING OPERATIONS
  [ 1.1 ] Sterile Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
      [ 1.1.1.2 ] Lyophilisates
      [ 1.1.1.4 ] Small volume liquids
      [ 1.1.1.6 ] Other aseptically prepared products
Cytotoxics
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
      [ 1.1.2.3 ] Small volume liquids
  [ 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
      [ 1.2.1.13 ] Tablets
  [ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
      [ 1.4.2.1 ] Filtration
      [ 1.4.2.3 ] Moist heat
  [ 1.5 ] Packaging
    [ 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
Contact Details
15/06/2016 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential