Caplin Point Labs gets USFDA approval for its new anticholinergic drug

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India based mid-cap pharmaceutical company. Caplin Point Laboratories has announced that “One of its subsidiaries received an anticholinergic drug approval from US health regulator.”

The company in its statement on Friday said that “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 for the application (ANDA) Glycopyrrolate injection USP 0.mg/ml.”

The company’s chairman, C C Paarthipan in his statement said that “It is an important milestone in our journey in the regulated markets and we’re working towards launching the product shortly in the US market.”

Glycopyrrolate is a generic therapeutic equivalent version of Robinul from West-Ward Pharmaceuticals International Limited.

According to IQVIA (IMS Health), Glycopyrrolate had a US sales data of approximately $110.12 Million for the 12 months ending December 2018.

Caplin Sterlies has so far developed and filed 11 ANDAs in which seven are of Caplin Steriles and 4 with the partners. The company has so now got four approvals in which three approvals are through partners, and current approval is the first under its name.