Glycopyrrolate is a generic therapeutic equivalent version of Robinul from West-Ward Pharmaceuticals International Limited.
Caplin Point Laboratories shares rallied nearly 3 percent intraday on Friday after its subsidiary received approval from the US health regulator for the anticholinergic drug.
The stock was quoting at Rs 412.00, up Rs 8.50, or 2.11 percent on the BSE, at 13:27 hours IST.
Caplin Steriles, a wholly owned subsidiary of Caplin Point Laboratories, 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, the company said.
Glycopyrrolate is a generic therapeutic equivalent version of Robinul from West-Ward Pharmaceuticals International Limited.
"It is an important milestone in our journey in the regulated markets and we're working towards launching the product shortly in the US," C C Paarthipan, Chairman said.
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 its own name.
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