INDIA – Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (U.S. FDA) for its generic oral diabetes medication.

According to the company’s press release, the U.S. FDA has granted ANDA approval for Glenmark’s Saxagliptin tablets as a first-line treatment option for patients with type 2 diabetes.

This news comes after Glenmark received a 2nd tentative approval by the U.S. FDA for its Saxagliptin Tablets, 2.5 mg, and 5 mg, in mid-February this year.

After the final approval, Glenmark will sell its generic diabetes drug, Saxagliptin Tablets, in the form of hard capsules in strengths of 2.5 mg and 5mg.

Glenmark’s antidiabetic medications are the generic equivalents of Onglyza tablets, 2.5 mg, and 5 mg, manufactured by AstraZeneca AB, AstraZeneca’s largest production and product support unit in Sweden.

The IQVIATM sales data for the 12‐month period ending June 2023 highlighted that the Onglyza Tablets, 2.5 mg, and 5 mg, achieved annual sales of approximately US$100.7 million. 

Hence, Glenmark’s Saxagliptin tablets will go head-to-head with AstraZeneca AB’s Onglyza tablets in the coming months.

Comparably, Glenmark launched its groundbreaking anti-diabetic drug, Zita D, for the treatment of type 2 diabetes patients, particularly individuals with comorbid conditions, last year.

Glenmark’s Saxagliptin tablets, 2.5 mg, and 5 mg, will be distributed in the United States by its fully-owned subsidiary Glenmark Pharmaceuticals Inc., USA.

This FDA approval is a momentous milestone in Glenmark’s history as it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

It represents the continued expansion of the pharmaceutical company’s business into the pharmaceutical distribution market in the United States.

Furthermore, the full FDA approval of Glenmark’s Saxagliptin tablets is a clear reflection of the company’s commitment to ensuring patients have access to high-quality, affordable medicine worldwide.

Glenmark’s current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 49 ANDAs pending approval with the U.S. FDA.

The innovation-driven global pharmaceutical company has a presence across specialty, generics, and over-the-counter businesses.

Moreover, the over-the-counter market has long been an important segment of Glenmark’s portfolio around the world.

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