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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 17543 Insp GMP 17543/9621-0025 [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 : INTAS PHARMACEUTICALS LIMITED
 
Site address : INTAS PHARMACEUTICALS LIMITED, PLOT NUMBERS 457,458 & 191/218P, SARKHEJ- BAVLA HIGHWAY, MATODA, SANAND, AHMEDABAD, IN-382210, INDIA
  Other :
Desktop assessment for the extension to the validity of the sites GMP certificate that was set to expire December 2024.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 06/03/2025, 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
  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
(PFS)
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
      [ 1.1.2.3 ] Small volume liquids
      [ 1.1.2.5 ] Other terminally sterilised prepared products
(PFS)
  [ 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
      [ 1.2.1.11 ] Semi-solids
for Ointments
      [ 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
    [ 1.5.1 ] Primary packaging
      [ 1.5.1.1 ] Capsules, hard shell
      [ 1.5.1.13 ] Tablets
      [ 1.5.1.17 ] Other non-sterile medicinal products
Onitments
    [ 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
Restrictions or Remarks
This certificate is issued based on a desktop assessment of GMP compliance information provided by the manufacturer and Marketing Authorisation Holders supplying product to the UK. A risk-based site inspection programme remains in force.
External Preparations and Central QC.
17/03/2025 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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