Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug application for Lenalidomide Capsules in different strengths.
Lenalidomide capsules are bioequivalent to Bristol-Myers Squibb Company’s Revlimid capsules 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg and indicated for the treatment of multiple myeloma. The product will be manufactured at Pithampur facility, Lupin said on Wednesday.
The estimated annual sales of Lenalidomide capsules in the U.S. was $7,511 million, the company said citing IQVIA MAT July 2025 numbers.
Nagpur plant under U.S. FDA scanner
Meanwhile, the Nagpur injectable facility of Lupin has received six observations from the U.S. FDA.
“The U.S. FDA conducted an inspection of Lupin’s Nagpur injectable facility from September 8-16. The inspection closed with six observations. We will address the observations and respond to the U.S. FDA within the stipulated timeframe,” the company intimated the stock exchanges on Tuesday evening.
Published – September 17, 2025 08:44 pm IST
