Caplin Point Laboratories receives USFDA approval for Glycopyrrolate injection

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, 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.

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.

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