Aurobindo Pharma subsidiary gets USFDA approval for Lenalidomide

8 Mar 2023 , 10:26 AM

Aurobindo Pharma Limited announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited (EPSG), has received final USFDA approval to manufacture and market Lenalidomide Capsules of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

The capsules are bioequivalent and therapeutically equivalent to Bristol-Myers Squibb’s Revlimid Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, and 20 mg.

The product is scheduled to be released in October 2023. (Volume-specific launch), said the company in its media release.

EPSG has just secured its 155th ANDA, which includes 9 tentative approvals. This achievement marks yet another milestone for the company, which specializes in manufacturing oral and sterile specialty products. 

This particular product has been approved for treating adult patients diagnosed with Multiple Myeloma, and it’s recommended to be used alongside Dexamethasone. 

This combination of medications has been effective in combating the disease, and the approval of this product provides a much-needed option for patients battling this condition.

At around 10.22 AM, Aurobindo Pharma was trading 0.73% higher at Rs470.25, against the previous close of Rs466.85 on NSE. The counter touched an intraday high and low of Rs470.95 and Rs458.60 respectively.

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