Lupin Receives FDA Approval to Manufacture Biosimilar Armlupeg at Pune Facility

Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar product, Armlupeg. The biosimilar will be manufactured at Lupin’s biotechnology facility located in Pune, India. Prior to granting approval, the FDA conducted an inspection of the manufacturing site.

The Pune-based biotech facility is equipped to produce Armlupeg following regulatory standards set by the FDA. This approval marks a significant milestone for Lupin’s operations in the biosimilar market. The company has not disclosed further details regarding distribution or launch timelines for the product in the United States.

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Date: December 1, 2025