Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) phenylephrine hydrochloride injection USP, 10 mg/mL single-dose Vial, 50 mg/5 mL (10mg/mL) pharmacy bulk package, and 100 mg/10 mL (10 mg/mL) pharmacy bulk package, a generic therapeutic equivalent version of (RLD), Vazculep injection, of Avadel Legacy Pharmaceuticals LLC.
Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anaesthesia.
C C Paarthipan, chairman of Caplin Point Laboratories Limited commented “We’re confident of growing well in the US, in terms of filings and revenues. We’re expecting some more ANDA approvals in the current FY which should augment our growth trajectory in the US. A few products in our pipeline are under shortage or for emergency usage, and we hope to receive priority review for those.”
The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products, to be filed over the next 4 years.
According to IQVIA (IMS Health), phenylephrine hydrochloride injection USP had US sales data of approximately $45 million for the 12-month period ending Mar 2020. Caplin Steriles Limited, has developed and filed 17 ANDAs on its own and with partners, with 9 approvals so far.