Caplin Steriles gets US FDA nod for Verapamil Hydrochloride injection

Our Bureau Mumbai | Updated on March 26, 2020

Shares up nearly 20 per cent

Caplin Steriles Ltd, a wholly-owned subsidiary of Caplin Point Laboratories Ltd, has received the final approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Verapamil Hydrochloride injection USP.

Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions like high blood pressure, arrhythmia and angina.

The approval is for 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.

According to IQVIATM (IMS Health), Verapamil Hydrochloride injection USP had US sales data of about $28 million for the 12-month period ending December 2019, the company said in a regulatory filing.

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

“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,” C.C. Paarthipan, Chairman of Caplin Point Laboratories said.

The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products, to be filed over the next four years.

At 1:12 PM, Caplin Point Laboratories shares were trading up by 19.99 per cent at Rs 244.60 on the BSE, which was also up by 5.06 per cent.

Published on March 26, 2020

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