Caplin Steriles secures USFDA nod for Neostigmine Methylsulfate Injection
Chennai: Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited, 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 (1 mg/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.
According to IQVIA (IMS Health), Neostigmine Methylsulfate Injection had US sales data of approximately $20 million for the 12-month period ending Dec 2020.
Caplin Steriles Ltd is a niche sterile product manufacturing company that is approved by US FDA and EU-GMP. The company has developed and filed 20 ANDAs in USA on its own and with partners, with 12 approvals so far.