Caplin Steriles receives USFDA approval for Ropivacaine Hydrochloride injection

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ropivacaine Hydrochloride injection USP, 0.2 % in 40 mg/20 mL (2 mg/mL), 0.5 % in 100 mg/20 mL (5 mg/mL), 0.5 % in 150 mg/30 mL (5 mg/mL) and 1 % 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 LLC.

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

 

Caplin Steriles, has developed and filed 16 ANDAs on its own and with partners, with 8 approvals so far.

Ropivacaine Hydrochloride is a long acting local anesthetic drug used for surgery or acute pain management.

C.C.Paarthipan, Chairman of Caplin Point Laboratories commented 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.

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