Strides Arcolab has received United States Food and Drug Administration (USFDA) approval for Acarbose Tablets, 25mg, 50mg and 100mg. Acarbose is a niche anti-diabetic drug used to treat type 2 diabetes mellitus. According to March 2011 IMS data, total US market for Acarbose Tablets approximated to $21 million with no Indian generic players in the market.
The Pharma division has a total of 37 filings with USFDA out of which 21 under the PEPFAR programme and 16 as Generics. Approvals to date are 22, 17 under PEPFAR and 5 Generics. This product will be marketed and sold by Perrigo under a profit share partnership. Product is expected to be launched shortly within Q3’ 2011.
Recently, Onco Therapies, a division of Agila, which is a wholly owned subsidiary of Strides Arcolab, had received United States Food and Drug Administration (US FDA) approval for Gemcitabine for Injection USP in 200mg, 1 gm and 2 gm dosage forms.
