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Glenmark Pharma bags USFDA nod for generic version of Otezla Tablets

Ruchika SharmaWritten by Ruchika Sharma Published On 18 Oct 2023 10:00 AM  |  Updated On 18 Oct 2023 10:00 AM
Glenmark Pharma bags USFDA nod for generic version of Otezla Tablets
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Mumbai: Glenmark Pharmaceuticals Ltd. has announced that the Company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg used for the treatment of plaque psoriasis and oral ulcers.

A product is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen Inc.

According to IQVIA sales data for the 12-month period ending August 2023, the Otezla Tablets, 10 mg, 20 mg, and 30 mg market achieved annual sales of approximately $3.7 billion*.

Glenmark’s current portfolio consists of 188 products authorized for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the U.S. FDA.

"In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio," The Company stated.

Read also: Submit Phase III CT Protocol: CDSCO Panel Tells Glenmark Pharmaceuticals on Antidiabetic FDC

Glenmark Pharmaceuticals Limited is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. The company has also been Great Place To Work Certified in India.
Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi).
Read also: Glenmark inks pact to market Cosmo Pharma acne treatment Winlevi in Europe, South Africa






glenmarkglenmark newsApremilast TabletsUSFDAOtezla Tabletsamgen
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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