Caplin Point Laboratories arm gets USFDA nod for Neostigmine Methylsulfate Injection

Caplin Point Laboratories on Thursday said its subsidiary has received approval from the US health regulator for Neostigmine Methylsulfate Injection.

Neostigmine Methylsulfate Injection is a cholinesterase inhibitor and is indicated for the reversal of the effects of non-depolariSing neuromuscular blocking agents (NMBAs) after surgery.

''Caplin Steriles Ltd (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 in the strengths of 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL),'' Caplin Point Laboratories said in a regulatory filing Multiple-dose vial presentations, a generic therapeutic equivalent version of (RLD), BLOXIVERZ Injection, of Exela Pharma Sciences, LLC, USA. Quoting IQVIA (IMS Health) data, Caplin Point Laboratories said Neostigmine Methylsulfate Injection had US sales data of approximately USD 20 million for the 12-month period ending Dec 2020.

Shares of Caplin Point Laboratories were trading 3.14 per cent higher at Rs 523.15 apiece on BSE.