New Certificates Of Suitability For Dishman Pharmaceuticals

September 17, 2010

In the last few months Dishman Pharmaceuticals has successfully obtained the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) for Indapamide and Bupivacaine HCl.

In the last few months Dishman Pharmaceuticals has successfully obtained the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) for the following Active Pharmaceutical Ingredients (API):

  • Indapamide
  • Bupivacaine HCl

The CEP are recognised by the European Union as a single reference work for the quality control of medicines. CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorization to demonstrate the compliance of the substance with the monographs of the European Pharmacopoeia. Besides, the official standards published within provide a legal and scientific basis for quality control during the development, production and marketing processes.

Dishman has also recently applied for the CEP for Hexetidine (whose European Drug Master File is currently available). These 3 new certificates complement the current list of Dishman Generic API documentation.

Other “traditional” APIs from Dishman with a CEP are: Tramadol, CPC, Cetrimide Powder, Bisacodyl USP and Benzalkonium Chloride 50%.

To see a full list of Dishman Generic APIs please go to:
www.dishmangroup.com/bulk-api-products.asp