Business EconomyPosted at: Mar 22 2019 2:11PM

Caplin Steriles gets USFDA approval for Glycopyrrolate Injection

Mumbai, Mar 22(UNI) Caplin Point Laboratories said that Caplin Steriles Limited a Wholly Owned Subsidiary of company, 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 are 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 USD110.12 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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Caplin Steriles gets USFDA approval for Glycopyrrolate Injection

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