Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 14967 Insp GMP 14967/5900-0012[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 : KOPRAN LIMITED
 
Site address : KOPRAN LIMITED, VILLAGE SAVROLI, KHALAPUR, RAIGAD, IN-410202, 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 19/09/2016, 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
  [ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.1 ] Capsules, hard shell
      [ 1.2.1.8 ] Other solid dosage forms
      [ 1.2.1.13 ] Tablets
  [ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
Restrictions or Remarks
This updated certificate is based on an inspection carried out in September 2016 - see front page for dates.

Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams).
In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate
In Plant I only blister packaging line 2 is included in the scope of this certificate
This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details.

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams) In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate In Plant I only blister packaging line 2 is included in the scope of this certificate This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details.
Contact Details
29/01/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential