Caplin Point Laboratories’ arm gets USFDA’s nod for Verapamil Hydrochloride injection

26 Mar 2020 Evaluate
Caplin Steriles, a wholly owned subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Verapamil Hydrochloride injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL) Single-dose vial, a generic therapeutic equivalent version of (RLD), Isoptin Injection, 2.5 mg/mL, of Mt. Adams Technologies LLC.

According to IQVIA (IMS Health), Verapamil Hydrochloride injection USP had US sales data of approximately $28 million for the 12-month period ending December 2019. Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias and angina.

Caplin Steriles has developed and filed 15 ANDAs on its own and with partners, with 7 approvals so far. 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.

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.

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