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The Certificate has been withdrawn, withdrawn date is : 2024-01-30

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National Center For Public Health And Pharmacy

CERTIFICATE NUMBER: OGYÉI/38211-8/2023

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of HUNGARY confirms the following:

The manufacturer: Bdr Lifesciences Private Limited

Site address:

Rs No 578 Near Effluent Channel Road, Village Luna, Padra Taluka, Vadodara, -, India

OMS Organisation Id. / OMS Location Id.: ORG-100034093 / LOC-100053921

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-08-27 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

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)
           1.2.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: cytostatics/cytotoxics(en)
           1.2.1.13  Tablets
                  Special Requirements:
                   7  Other: cytostatics/cytotoxics(en)
           1.2.1.17  Other: film-coated tablets(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: cytostatics/cytotoxics(en)
           1.5.1.13  Tablets
                  Special Requirements:
                   7  Other: cytostatics/cytotoxics(en)
           1.5.1.17  Other non-sterile medicinal products: film-coated tablets(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

This GMP certificate is valid up to 3 years

Withdrawal comments in English: Wrong LOCATION ID was used

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