Caplin Point Subsidiary Secures Approval from the USFDA

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Linezolid Injection 600mg/300mL in Single-dose Infusion Bag.

The medicine is a generic version of Pfizer’s ZYVOX and is primarily used to treat severe bacterial infections, such as pneumonia and skin infections, particularly those that are resistant to other antibiotics.

IQVIA, a global healthcare and analytics business, reports US sales of around $23 million for the fiscal year ending October 2025.

Caplin Steriles has developed and filed 53 ANDAs in the United States, 44 of which have been approved, and is now working on a pipeline of over 40 injectable and ophthalmic drugs for future filings.

Caplin Point Laboratories operates as a pharmaceutical company with a distinctive business model focused mainly on serving emerging markets in Latin America and Africa. At the same time, it is expanding its footprint in regulated markets, including the US, through its subsidiaries Caplin Steriles and Caplin Steriles USA Inc.

The corporation also holds permits in many non-US markets, including Australia, Canada, Mexico, Chile, the United Arab Emirates, and Saudi Arabia.

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