Ajanta Pharma got the final USFDA approval for Entacapone tablets which is used for treating the Parkinson’s disease.
Ajanta Pharma said that it has received the final approval for Entacapone tablets from US FDA in a BSE filing. Entacapone tablets are bioequivalent generic version of Comtan tablets.
Ajanta Pharma company said that they will launch the Entacapone tablets shortly with 200 mg strength. This new approval from US FDA is a part of portfolio f products which the company developed for the US market.
Ajanta Pharma has 35 ANDAs (Abbreviated new drug applications and it has final approval for 20 ANDAs. It has tentative approval for 2 ANDA and 13 ANSAs are under review with US FDA.
The Ajanta Pharma shares were trading 0.36 per cent up at Rs 1,205.25 on the BSE.