U.S. FDA approves Alembic Pharma’s Clonazepam tablets to treat seizure
Category: #health  By Pankaj Singh  Date: 2019-07-02
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U.S. FDA approves Alembic Pharma’s Clonazepam tablets to treat seizure

Alembic Pharmaceuticals, an Indian multinational drug manufacturing company, recently announced that the U.S. Food and Drug administration has granted approval for its orally disintegrating Clonazepam tablets used specifically to treat seizures.

Reportedly, the product is therapeutically equivalent to Klonopin orally disintegrating tablets, a reference listed drug, developed by Hoffmann-La Roche, Inc. Clonazepam is useful as an adjunct or alone in the treatment of Lennox-Gastaut syndrome, myoclonic and akinetic seizures.

Alembic Pharmaceuticals confirmed in a BSE filing that the company’s abbreviated new drug application (ANDA) for Clonazepam orally disintegrating tablets has won approval from the United States Food and Drug Administration. These tablets have strengths ranging from 0.125mg to 2mg. Alembic Pharmaceuticals’ shares had been trading 0.52 percent higher at Rs. 509 on the Bombay Stock Exchange at the time.

According to the data from IQVIA , the estimated market size for clonazepam orally disintegrating tablets USP is around $20 million during the 12 months ending December 2018. Till date, the USFDA has granted the company 98 ANDA approvals out of which 86 are final approval and 12 of them are tentative, sources familiar with the matter informed.

For the uninitiated, a multinational pharmaceutical company situated in Vadodara, Gujrat, Alembic Pharmaceuticals is involved in the manufacturing of pharmaceutical substances, intermediates and pharmaceutical products. Established 1907, the company is leading in the market for anti-infective drugs’ macrolides segment in India.

Alembic Pharmaceutical is also involved in real estate and power generation sectors, with the latter carried out through windmills and cogeneration power plants and is wholly used for captive consumption. It is also engaged in manufacturing and marketing of chemistry and fermentation based Active Pharmaceuticals Ingredients (API), sources mentioned. The company is currently publicly listed for manufacturing and marketing pharmaceutical products around the world.

 

Source Credits- https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-usfda-nod-for-seizure-treatment-drug/articleshow/70019754.cms

https://www.thehindubusinessline.com/companies/alembic-pharma-gets-usfda-nod-for-seizure-treatment-drug/article28240654.ece



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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