Our four best-in-class, cGMP-compliant formulation manufacturing facilities manufacture a wide range of injectables using aseptic filling or terminal sterilization, as applicable. The facilities are equipped for production flexibility and can switch product lines seamlessly, eliminating need to install additional production lines to meet altered product specifications and market mechanics of demand and supply.
Our facilities have received accreditations from the following regulatory bodies:
Our 600,000 sq. ft. flagship sterile injectable facility in Dundigal, Hyderabad - USFDA approved since 2003 - possesses capabilities across various delivery formats.
The sterile injectable facility in Pashamylaram, Hyderabad, after selling in the domestic since July, 2015; obtained USFDA approval in April 2016 and entered the USA market in September 2016. Output at this facility has nearly doubled our manufacturing capacity.
A dedicated Penems facility, after filing its first ANDA in September 2013, obtained USFDA approval in April 2016.
Our oncology facility after receiving USFDA and GMP (EU) approval in 2014, began sales in Europe in 2015 and in the United States in 2016.