Dr. Reddy’s Receives Two USFDA Observations for New York API Manufacturing Plant

18 May 2025 , 07:17 PM

Dr. Reddy’s Laboratories (DRL), one of leading pharmaceutical company in India, on Thursday said the United States Food and Drug Administration (USFDA) has issued a Form 483 with two observations, after the inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility of Dr. Reddy’s Laboratories, Inc., located in Middleburgh, New York.

The Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. The company has not revealed details of the observations, however, it is anticipated that the company will address and correct them in the interests of FDA regulations.

This is a significant development since pharmaceutical companies have to comply with USFDA norms in order to manufacture and market their products in the U.S. Dr. Reddy’s operates in more than 30 countries worldwide and uses over 110 including world’s largest markets India and USA.

In the National Stock Exchange, shares of Dr. Reddy’s Laboratories has gained a total of 6.3% in the last year, and 4.2% in the last month.