Glenmark Pharmaceuticals Receives U.S. FDA Approval

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.

Product Information

The 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 Portfolio

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.

Company Overview

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).

Related Articles

• Submit Phase III CT Protocol: CDSCO Panel Tells Glenmark Pharmaceuticals on Antidiabetic FDC
• Glenmark inks pact to market Cosmo Pharma acne treatment Winlevi in Europe, South Africa