USFDA nod to Caplin Steriles Linezolid Injection to treat serious bacterial infections
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-09 09:32 GMT | Update On 2025-12-09 09:32 GMT
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Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Linezolid Injection 600mg/300mL (2mg/mL) Single-dose Infusion Bags.
The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) ZYVOX from
Linezolid Injection is an anti-bacterial primarily used to treat serious bacterial infections, including pneumonia and skin infections, particularly those resistant to other antibiotics.
According to IQVIA (IMS Health), Linezolid Injection had US sales of approximately $23 million for the 12-month period ending October 2025.
Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited has developed and filed 53 ANDAs in USA on its own and with partners (including four ANDAs acquired from third parties), with 44 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, Saudi Arabia etc.
Its parent, Caplin Point Laboratories Limited is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms.
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