Caplin Steriles bags USFDA approval for local anesthetic drug

Our Bureau Mumbai | Updated on April 13, 2020

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

Ropivacaine Hydrochloride is a long-acting local anesthetic drug used for surgery or acute pain management. 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, the company said in a statement.

“We’re glad to receive this approval, particularly as this product has been frequently on the shortage list in the US in recent times. We would be launching this product shortly, and hope to alleviate some of the shortages,” C.C. Paarthipan, Chairman of Caplin Point said.

The company has received final approval for Ropivacaine Hydrochloride injection USP 0.2 per cent in 40 mg/20 mL (2 mg/mL), 0.5 per cent in 100 mg/20 mL (5 mg/mL), 0.5 per cent in 150 mg/30 mL (5 mg/mL) and 1 per cent in 200 mg/20 mL (10 mg/mL) Single-dose vial presentations, a generic therapeutic equivalent version of (RLD), Naropin Injection of Fresenius Kabi USA.

According to IQVIATM (IMS Health), Ropivacaine Hydrochloride injection USP had US sales data of about $34 million for the 12-month period ending December 2019.

Caplin Steriles has developed and filed 16 ANDAs on its own and with partners, with eight approvals so far.

Published on April 13, 2020

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