Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has achieved a significant milestone with the United States Food and Drug Administration (USFDA) granting final approval for its Abbreviated New Drug Application (ANDA) for Linezolid Injection, 600 mg/300 mL (2 mg/mL) single-dose infusion bags.
On December 9, 2025, Caplin Steriles Limited announced the USFDA's final approval for its Linezolid Injection, a generic therapeutic equivalent to Pfizer Inc.'s Reference Listed Drug (RLD), ZYVOX.
Linezolid Injection is primarily used to treat serious bacterial infections, including pneumonia and skin infections, particularly those resistant to other antibiotics.
According to IQVIA, Linezolid Injection had US sales of approximately $23 million for the 12-month period ending October 2025.
Caplin Steriles Limited is a rapidly growing sterile product manufacturing company, approved by several regulatory agencies, including the USFDA, EU-GMP, ANVISA, and INVIMA.
The company has developed and filed 53 ANDAs in the USA, with 44 approvals so far. It is also working on a portfolio of 40+ injectable and ophthalmic products for future filings.
Additionally, Caplin Steriles has multiple products filed and approved in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, and Saudi Arabia.
As of December 09, 2025, at 2:09 PM, Caplin Point Laboratories share price on NSE was trading at ₹1,903.40 down by 1.26% from the previous closing price.
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Caplin Steriles Limited's recent USFDA approval for Linezolid Injection marks a significant achievement for the company, reflecting its commitment to expanding its product offerings and regulatory approvals. This approval further solidifies Caplin Steriles' position in the pharmaceutical industry, particularly in the US market.
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Published on: Dec 9, 2025, 2:38 PM IST
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