Caplin Steriles gets USFDA approval
Pharma

Caplin Steriles gets USFDA approval

The injection comes in multiple formats

  • By ICN Group | April 23, 2021

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.

The injection comes in multiple formats - 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.

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 US $20 million for the 12-month period ending December 2020.

Caplin Steriles, a subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by US FDA and EU-GMP. Caplin Steriles has developed and filed 20 ANDAs in the USA on its own and with partners, with 14 approvals so far. The company is also working on a portfolio of 45 simple and complex injectable and ophthalmic products that it intends to file over the next 4 years.

Other Related stories

Startup

Chemical

Petrochemical

Digitization

Gas