Glenmark Pharmaceuticals Gains USFDA Approval for Apremilast Tablets, Targets Skin Care Sector

Glenmark Pharmaceuticals, a prominent player in the pharmaceutical industry, achieved a significant milestone as it received final approval from the US Food & Drug Administration (USFDA) for its Apremilast Tablets. These tablets are intended for the treatment of plaque psoriasis and oral ulcers, further enhancing Glenmark's presence in the dermatology sector.

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Glenmark Pharmaceuticals, a prominent player in the pharmaceutical industry, achieved a significant milestone as it received final approval from the US Food & Drug Administration (USFDA) for its Apremilast Tablets. These tablets are intended for the treatment of plaque psoriasis and oral ulcers, further enhancing Glenmark's presence in the dermatology sector.

The US FDA's approval covers Apremilast Tablets in three distinct strengths: 10 mg, 20 mg, and 30 mg. These tablets are a generic alternative to Amgen Inc.'s Otezla tablets, which come with the same strengths. Glenmark's announcement highlighted the potential of Apremilast Tablets, underlining their role in treating a range of skin conditions.

Otezla tablets, which serve a similar purpose, achieved staggering annual sales of approximately USD 3.7 billion in the 12 months leading up to August 2023, as reported by IQVIA sales data. This approval positions Glenmark Pharmaceuticals to tap into this lucrative market and cater to the needs of patients with psoriasis arthritis and moderate to severe plaque psoriasis, a specific skin ailment.

Glenmark Pharma, with an impressive portfolio of 188 products authorized for distribution in the US market, currently has 50 Abbreviated New Drug Applications (ANDAs) pending approval with the US FDA. This showcases the company's commitment to expanding its presence in the pharmaceutical industry.

In addition to its dermatology offerings, Glenmark Pharmaceuticals maintains a robust presence across various segments, including branded, generic, and over-the-counter (OTC) products. It primarily focuses on respiratory, dermatology, and oncology products.

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Operating across four continents with ten manufacturing facilities and a presence in over 80 countries, Glenmark is well-positioned to cater to a global clientele. Moreover, in a strategic move, the pharma giant's subsidiary, Glenmark Specialty SA, recently entered into a distribution and license agreement with Cosmo Pharmaceuticals NV. The partnership aims to introduce Winlevi (Clascoterone cream 1%) in the European and South African markets. Glenmark will have exclusive rights to commercialize Winlevi in 15 EU countries, South Africa, and the UK, offering a promising solution for acne treatment in patients aged 12 years and older.

Glenmark's success is reflected in the stock market, with Glenmark shares trading 0.63 percent higher at Rs 802.50 on the Bombay Stock Exchange (BSE) at 9.43 AM. This marks the third consecutive day of positive performance for the company's shares.