Caplin gets USFDA nod for generic Isoptin injection

Caplin Point Laboratories Limited, has been granted final approval from the USFDA for verapamil hydrochloride injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL) single-dose vial

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Medicine Injection
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Caplin Point Laboratories Limited, a wholly owned 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) 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 US$28 million for the 12-month period ending Dec 2019. Verapamil hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias and angina.

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Caplin Steriles Limited, has developed and filed 15 ANDAs on its own and with partners, with 7 approvals so far. CC Paarthipan, chairman of Caplin Point Laboratories Limited said, “We are pleased to receive another approval under Caplin Steriles name and we would be launching this product in the US soon. We’re also expecting a couple more approvals shortly, which should enhance our revenue traction in the US.”

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.