Caplin Point Laboratories’ Wholly Owned 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 Limited. Glycopyrrolate is an anticholinergic drug.
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.
Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.
