Caplin Point Laboratories’ wholly owned 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. The company, 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.
Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.
