Caplin Steriles Limited, the subsidiary of Caplin Point Laboratories, has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Linezolid Injection 600mg/300mL (2mg/mL) in single-dose infusion bags. This product is the generic therapeutic equivalent to ZYVOX, the branded drug developed by Pfizer.
Linezolid Injection is a key antibiotic used to treat severe bacterial infections such as pneumonia and complicated skin infections, especially in cases where bacteria are resistant to standard treatments. With rising antimicrobial resistance globally, the availability of a cost-effective generic version is expected to support hospitals and healthcare providers in managing critical infections.
Market data from IQVIA (IMS Health) indicates that Linezolid Injection generated around $23 million in US sales for the 12-month period ending October 2025. The USFDA approval positions Caplin Steriles to tap into this market and expand its footprint in the US injectable segment.
