Caplin Steriles secures USFDA approval for Linezolid injection

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, announced on December 9, 2025, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Linezolid Injection 600mg/300mL (2mg/mL) Single-dose Infusion Bags. This generic therapeutic equivalent version is for the Reference Listed Drug (RLD) ZYVOX from Pfizer Inc.

Linezolid Injection is an antibacterial used to treat serious bacterial infections, including pneumonia and skin infections, especially those resistant to other antibiotics. According to IQVIA™ (IMS Health), US sales for Linezolid Injection were approximately $23 million for the 12-month period ending October 2025.

Caplin Steriles has developed and filed 53 ANDAs in the USA, with 44 approvals granted so far. The company is also developing a portfolio of over 40 injectable and ophthalmic products for future filings and has multiple product approvals in non-US markets.