Caplin Steriles gets USFDA approval for glycopyrrolate injection

Chennai, Mar 22, 2018: Caplin Point Laboratories Limited (BSE: CAPLL (524742),NSE: CAPLIPOINT) announced that Caplin Steriles Limited (a Wholly OwnedSubsidiary of Caplin Point Laboratories Ltd), has been granted final approval by the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Glycopyrrolate injection USP, 0.2mg/ml (in 1 ml, 2 ml, 5 ml and 20 ml vial presentations), a generic therapeutic equivalent version of Robinul from West-Ward Pharmaceuticals International Limited. Glycopyrrolate is an anticholinergic drug. “We’re happy to receive this nod from USFDA for Glycopyrrolate injection USP,which is the first ANDA approval for Caplin Sterlies under our own name and it is the 4th approved ANDA from our facility. It’s an important milestone in our journey in the regulated markets and we’re working towards launching the product shortly in the US”, said Mr. C.C.Paarthipan, Chairman of Caplin Point Laboratories Ltd. According to IQVIA™ (IMS Health), Glycopyrrolate had US sales data of approximately $110.12 Million for the 12 month period ending December 2018. Caplin Steriles has developed and filed a total of 11 ANDAs, of which 7 are on its own (Caplin Steriles) and 4 with partners. We have 4 approvals so far of which three through partners and current approval is the first under our own name.

About Caplin Point Laboratories Limited:

Caplin Point Laboratories Limited is a niche pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. Caplin Point has state-of-the-art manufacturing facilities that cater to a complete range of finished dosage forms. The Company has over 2,800 product approvals across the globe with another 250+ in the pipeline. The Company’s Wholly Owned Subsidiary Caplin Steriles Ltd caters to the Regulated Markets for Injectable and Ophthalmic products.Caplin Point has been selected on Forbes Asia’s “200 Best Under a Billion” list for three consecutive years (2014, 2015 & 2016), and was recently awarded “The Emerging Company of 2018” and “Business Excellence Award for 2019” by Economic Times.