Caplin Point Laboratories’ arm gets USFDA’s nod for Neostigmine Methylsulfate Injection

22 Apr 2021 Evaluate

Caplin Point Laboratories’ subsidiary company -- Caplin Steriles (Caplin), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Neostigmine Methylsulfate Injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), Multiple-Dose vial presentations, a generic therapeutic equivalent version of (RLD), BLOXIVERZ Injection, of Exela Pharma Sciences, LLC, USA.

Neostigmine Methylsulfate Injection is a cholinesterase inhibitor and is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. Neostigmine Methylsulfate Injection had US sales data of approximately $20 million for the 12-month period ending December 2020.

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.

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