Glenmark Pharmaceuticals Inc., USA (Glenmark) has receivedtentative approval by the United States Food & Drug Administration (U.S. FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta®1 Tablets, 1 mg and 5 mg, of PF Prism C.V.

According to IQVIATM sales data for the 12 month period ending October 2020, the Inlyta® Tablets, 1 mg and 5 mg market achieved annual sales of approximately $518.8 million.

Glenmark's current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 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 andaccelerate the growth of its existing pipeline and portfolio.

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Glenmark Pharmaceuticals announced on 28 November 2020 that it has entered into a definitive agreement with Dr. Reddy's Laboratories to divest - subject to completion of certain precedent actions and closing activities - its brand Momat Rino (for Russia, Kazakhstan and Uzbekistan), Momat Rino Advance (for Russia), Momat A(for Kazakhstan and Uzbekistan), Glenspray and Glenspray Active (for Ukraine), along with rights to the trademarks, dossiers and patents for the territories mentioned.

The divested brand and its extensions represent two types of products, (a) Mometasone mono product and (b) combination of Mometasone with Azelastine, and are indicated for the treatment of Seasonal and Perennial Allergic Rhinitis.

Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Limitedcommented, “In line with our strategy to launch Ryaltris, our global anti-allergy brand, inthe markets of Russia and other CIS countries, we decided to divest the Momat Rino brandand its extension. As we await approval to launch Ryaltris in the Russian market, we lookforward to strengthening our respiratory franchise in the Russia/CIS region. We remaincommitted to the respiratory space globally.”

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Glenmark Pharmaceuticals announced that the company has been listed inthe Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of CorporateSustainability within each industry featured in the index.

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Glenmark Pharmaceuticals announced that S&P Global Ratings has affirmed the long-term issuer credit rating on Glenmark and the issue rating on the company's US$200 million senior unsecured notes at 'BB-'. At the same time, the credit rating agency has removed all the ratings from CreditWatch with negative implications. The outlook has been changed to Stable.

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