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Main  >  News  >  Roszdravnadzor announces the suspension of certificates of suitability of two pharmaceutical substances

Roszdravnadzor announces the suspension of certificates of suitability of two pharmaceutical substances

The Federal Service for Supervision of Healthcare (Roszdravnadzor) reports that the Special Committee of the European Directorate for the Quality of Medical Products (EDQM) made decisions dated 01.10.2020 on the suspension of certificates of suitability (CEP):

• CER 2012-239 for the substance Olmesartana Medoxomil, manufactured by Dr. Reddy’s Laboratories Ltd., India;
• R0-CEP 2017-286-Rev 00 on the substance “Prednisolone Acetate” micronized, sterile ”manufactured by Farmabios S.p.A., Italy (Farmabios SpA, Italy), as well as the closure of a new appendix to the certificate of suitability for the substance“ Triamcinolone acetonide sterile ”from the manufacturer.

The decision regarding the Indian manufacturer, Dr. Reddy’s Laboratories Ltd., was made on the basis that it simply stops production of the substance, but the certificates of suitability of pharmaceutical substances of the Italian company Farmabios SpA were suspended on the basis of non-compliance with GMP requirements by the manufacturer.

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