Glenmark Pharmaceuticals, a prominent global pharmaceutical company, has achieved a significant milestone by securing final approval from the United States Food and Drug Administration (USFDA) for the production and distribution of Apremilast Tablets. These tablets are available in three strengths: 10 mg, 20 mg, and 30 mg and serve as the generic equivalent of Amgen Inc.’s renowned medication, Otezla.
Apremilast, a prescription medication, plays a crucial role in the treatment of various medical conditions, including plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease. The USFDA’s approval of Glenmark’s generic version offers a more accessible and cost-effective option for individuals in need of these treatments.
The significance of this achievement is underscored by the fact that Otezla Tablets, in their 10 mg, 20 mg, and 30 mg variants, have been a substantial player in the pharmaceutical market. According to IQVIA’s annual sales data, which was last updated in August 2023, Otezla Tablets generated impressive annual sales of approximately $3.7 billion. Glenmark’s entrance into this segment as a generic alternative is expected to have a considerable impact on the pharmaceutical landscape, providing more affordable options for patients while maintaining quality standards.
Glenmark Pharmaceuticals currently boasts a robust portfolio of 188 products authorized for distribution in the competitive US marketplace. In addition to the products already in circulation, the company has 50 Abbreviated New Drug Applications (ANDAs) awaiting approval from the USFDA. This signifies Glenmark’s commitment to expanding its presence in the pharmaceutical industry and offering a wide range of treatment options to address various medical conditions.
The approval of Apremilast Tablets by the USFDA is a testament to Glenmark’s dedication to delivering high-quality pharmaceutical solutions. This milestone not only showcases their expertise in generic medication manufacturing but also their commitment to enhancing accessibility to vital treatments for patients.
In conclusion, Glenmark’s latest achievement in gaining USFDA approval to market the generic version of Apremilast Tablets is a significant development in the pharmaceutical field. It reflects the company’s mission to broaden its pharmaceutical offerings, ensuring that patients have access to cost-effective yet efficacious treatments for their medical conditions.
