Glenmark gets ANDA approval from USFDA for apremilast tablets, ET HealthWorld


Mumbai: Glenmark Pharmaceuticals Ltd has obtained final approval from the United States Food & Drug Administration (U.S. FDA) for Apremilast tablets in 10 mg, 20 mg, and 30 mg variants. These tablets are the generic counterparts of Otezla® Tablets, which come in 10 mg, 20 mg, and 30 mg versions and are originally manufactured by Amgen Inc.

As per IQVIATM sales data covering the 12-month period up to August 2023, the market for Otezla® Tablets in these dosage forms achieved annual sales of around $3.7 billion.

Glenmark’s current portfolio includes a total of 188 products that have been authorised for distribution in the U.S. marketplace. Additionally, they have 50 ANDA‘s (Abbreviated New Drug Applications) awaiting approval from the U.S. FDA.

Furthermore, Glenmark is actively seeking and exploring external development partnerships to complement and expedite the growth of its existing pipeline and portfolio in the pharmaceutical industry.

  • Published On Oct 17, 2023 at 02:17 PM IST

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