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Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP

Published

7 September 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at biospace.com

Verified

Fusion42 · 7 September 2026 · Fusion42 review

Lupin Limited has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP in 100 mg and 200 mg strengths, marking a regulatory milestone for the company's pharmaceutical product portfolio.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ The Wire takeaway

You have new market access in the US pharma space due to Lupin's FDA nod for modafinil tablets, opening a route to compete or collaborate in CNS drug segments. Prepare for increased competition or partnership requests in this drug class.

Coverage

1 source · 7 Sep 2026

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Topics

Biotechmodafinilfda-approvalpharma-regulatorydrug-launchlupin