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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 31637 Insp GMP 31637/23565175-0001[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 : SHILPA MEDICARE LIMITED
 
Site address : SHILPA MEDICARE LIMITED, UNIT VI, PLOT NO 29A5, 4TH PHASE, AVVERAHALLI, SOMPURA INDUSTRIAL AREA, DABASPET, BENGALURU, IN-562 111, INDIA
 

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Part 16 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 18/05/2022, 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
  [ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.8 ] Other solid dosage forms
  [ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
      [ 1.5.1.8 ] Other solid dosage forms
    [ 1.5.2 ] Secondary packaging
  [ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
Restrictions or Remarks
The GMP certificate is applicable to the manufacture, packaging and testing of oral dispersible films only.
12/07/2022 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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