Caplin Steriles Limited, a 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) 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.
Ropivacaine hydrochloride is a long acting local anesthetic drug used for surgery or acute pain management.
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C C Paarthipan, chairman of Caplin Point Laboratories Limited 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.”
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. According to IQVIA (IMS Health), ropivacaine hydrochloride injection USP had US sales data of approximately $34 million for the 12-month period ending December 2019.
Caplin Steriles Limited, has developed and filed 16 ANDAs on its own and with partners, with 8 approvals so far.