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(17 Oct 2023, 09:43)

Glenmark Pharma gets US FDA approval for psoriasis-treatment drug

Glenmark Pharmaceuticals said that it has received final approval by the United States Food & Drug Administration (US FDA) for Apremilast Tablets, the generic version of Otezla Tablets of Amgen Inc.


Apremilast is a medicine used in treatment of psoriasis. This medicine is used when a patient does not respond to other conventional treatment. It decreases the pain and swelling in the affected area.

According to IQVIA sales data for the 12-month period ending August 2023, the Otezla Tablets 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 global pharmaceutical company said in a statement.

Glenmark is an India-based pharmaceutical company focused on branded and generic formulation and novel drug development businesses.

Net profit of the company declined by 18% year-on-year to Rs 173.1 crore in Q1 FY24, while total revenue from operations increased by 22.48% to Rs 3,401.6 crore.

The scrip rose 0.79% to currently trade at Rs 803.80 on the BSE.


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