Shilpa Medicare gets USFDA nod for psoriatic arthritis drug Apremilast
Karnataka: Shilpa Medicare has recently announced that the company has received U.S Food and Drug Administration (USFDA) tentative approval for its abbreviated new drug application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021. The ANDA was filed as 'First to File' submission on NCE -1 date to seek eligibility for 180 days exclusivity.
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.