Glenmark Pharma Formulation Plant Receives Form 483 with Observation


The United States Food and Drug Administration (USFDA) issued Form 483 with an observation after an inspection at Glenmark Pharmaceuticals’ formulation manufacturing facility based in Aurangabad, India, between June 27, 2022 and July 1. 2022.

The Aurangabad site focuses on manufacturing formulations (OSD, inhaler and foam). This factory spans 30 acres and serves domestic and international markets.

The company stated that it undertakes to take all necessary measures to respond to its observations as soon as possible. “The company is committed to maintaining the highest quality manufacturing standards at all of its facilities around the world,” he added.

Glenmark Pharmaceuticals is a global pharmaceutical company with operations in the specialty, generic and over-the-counter sectors.

The pharmaceutical company’s consolidated net profit fell by 33.5% to Rs 155.59 crore on a 4.6% increase in net sales to Rs 2,961.15 crore in Q4 FY22 compared to Q4 FY21.

Shares of Glenmark Pharmaceuticals gained 1.81% to settle at Rs 394 on Friday, July 1, 2022.

Powered by Capital Market – Live News

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

Dear reader,

Business Standard has always endeavored to provide up-to-date information and commentary on developments that matter to you and that have wider political and economic implications for the country and the world. Your constant encouragement and feedback on how to improve our offering has only strengthened our resolve and commitment to these ideals. Even in these challenging times stemming from Covid-19, we remain committed to keeping you informed and updated with credible news, authoritative opinions and incisive commentary on relevant topical issues.
However, we have a request.

As we battle the economic impact of the pandemic, we need your support even more so that we can continue to bring you more great content. Our subscription model has received an encouraging response from many of you who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of bringing you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practice the journalism we are committed to.

Support quality journalism and subscribe to Business Standard.

digital editor


Comments are closed.