Marksans Pharma Ltd has announced that the Company has received Certificate of suitability for Metformin Hydrochloride drug substance from the European Directorate for the Quality of Medicines and Healthcare (EDQM). With the grant of this Certificate of Suitability for Metformin Hydrochloride drug substance by EDQM, the doors of European markets have opened for access for the Company's API business.
Company has a very dominant position in Metformin formulation supplies in Europe and has filed its ANDA's in USA for Metformin tablets. With API backup, Marksans in confident of capturing a great percentage of Metformin business in Europe and have competitive advantage for its product launch in USA.
It is a significant achievement as the Company is focusing on the Regulated Market for its growth. Apart from this, Company has also filed applications for other drug substances which are under consideration with EDQM. This Certificate is recognized by 35 signatory states of the European Pharmacopoeia Convention and by the European Union. Other Countries have also chosen 10 recognize them.
This Certifificate of Suitability can be used by the manufacturers of pharmaceutical products in their applications for marketing authorization to demonstrate the compliance of the drug substance used with the official monograph of European Pharmacopoeia.
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