Caplin Point Laboratories Limited (BSE: CAPLL (524742), NSE: CAPLIPOINT) announced that Caplin Steriles Limited (a Wholly Owned Subsidiary 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.
Shares of CAPLIN POINT LABORATORIES LTD. was last trading in BSE at Rs.405 as compared to the previous close of Rs. 405.75. The total number of shares traded during the day was 662 in over 48 trades.
The stock hit an intraday high of Rs. 411.65 and intraday low of 400. The net turnover during the day was Rs. 267186.