Elder Pharmaceuticals Ltd has said it is set to enter the regulated markets of European Union following the receipt of Certificate of Suitability (COS) from European Directorate for the Quality of Medicines and Healthcare (EDQM) for Diosmin API.
“The recognition by EDQM will immensely help the company to enter the regulated markets of European Union.... COS approval for Diosmin API will also enable the company to expand its global market share,” Elder Pharma Joint Managing Director Alok Saxena told PTI here.
Diosmin, a semi-synthetic drug, is an oral phlebotropic drug used in the treatment of venous system related diseases, Disease (HD), Microcirculatory and absorbent system.
“We have already received accreditation from Ministry of Health-Japan for our Active Pharmaceutical Ingredients (API) plant at Patalganga in Maharashtra,” he said.
Indian companies have emerged as the preferred supplier for APIs across the world and now rank amongst the top three API producers in the world. It is estimated that 40 per cent of the world’s API requirement is met by the country.
The global market size of Diosmin’s finished product is around $500 million of which the European markets account for approximately $255 million. Diosmin is predominantly a prescription medication in some European countries and is also sold as a nutritional supplement in rest of Europe.