Glenmark Pharma Gets US Health Regulator Nod For Generic Medication

According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million

Topics

Glenmark Pharmaceuticals | USFDA | Pharma Companies

Press Trust of India  |  New Delhi 



Glenmark Pharmaceuticals

').insertAfter(".article-content__img");$(".article-content__img div").find('div').remove();

on Wednesday said it has received approval from the US health regulator to market Sodium Phenylbutyrate tablets, used in treating urea cycle disorders, in America.

The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics' Buphenyl, the Mumbai-based drug maker said in a statement.

According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million.

Glenmark's current portfolio consists of 177 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the .

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


Subscribe to Business Standard Premium

Exclusive Stories, Curated Newsletters, 26 years of Archives, E-paper, and more!

First Published: Wed, November 02 2022. 13:48 IST


RECENT NEWS

Monzo Looks For US Banking License

Monzo is preparing a renewed push to secure a US banking licence, four years after abandoning its first attempt when tal... Read more

Crypto Firms Push Into US Banking

America’s cryptocurrency companies are scrambling to secure a foothold in the country’s traditional banking system, ... Read more

Parallel Banking: Stablecoins Are Now Global

Parallel Banking: How Stablecoins Are Building a New Global Payments SystemStablecoins—digital currencies pegged to tr... Read more

JPMorgan Deploys AI Chatbot To Revolutionize Research And Productivity

JPMorgan has deployed an AI-based research analyst chatbot to enhance productivity among its workforce, with approximate... Read more

Private Equity And Banks: The Complex Web Of Leverage

Private equity has emerged as a significant force in the global financial landscape, driving substantial growth and inve... Read more

Financial Watchdog Highlights Unresolved Vulnerabilities In Shadow Banking Sector

The world’s leading financial stability watchdog has issued a warning about the unresolved vulnerabilities within the ... Read more