Strides Arcolab gets USFDA approval for Acarbose Tablets

28 Jul 2011 Evaluate

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.

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