Lupin Secures US FDA Tentative Approval for Oxcarbazepine ER Tablets Manufactured in Nagpur

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Oxcarbazepine extended-release (ER) tablets. The medication, intended for the US market, will be manufactured at Lupin’s facility in Nagpur, India. This development marks a step forward in Lupin’s efforts to expand its pharmaceutical offerings internationally.

The approval is classified as “tentative,” indicating that while the product meets all regulatory requirements set by the US FDA, final approval may depend on patent or exclusivity constraints related to other manufacturers. Oxcarbazepine ER tablets are used primarily in the treatment of epilepsy and certain types of seizures. Lupin’s Nagpur facility will handle production of this medication, ensuring compliance with stringent quality standards required for distribution in the United States.

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Source: GO-AI-ne1

Date: June 9, 2025

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Mark Chiang