Dr. Reddy’s U.S. plant gets FDA observations

Dr. Reddy’s Laboratories’ API manufacturing plant in Middleburg, New York, has received 3 observations following an U.S. Food and Drug Administration audit. “We have been issued a Form 483 with three observations… will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant,” the company informed the stock exchange on Wednesday. It, however, did not share details of the observations made by the regulator. Shares of the company closed with a gain of 1.15% at ₹4,498.65 apiece. The USFDA through Form 483 notifies the management of the company whose facility is inspected of the objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts.

You have reached your limit for free articles this month.

Subscription Benefits Include

Today’s Paper

Find mobile-friendly version of articles from the day’s newspaper in one easy-to-read list.

Unlimited Access

Enjoy reading as many articles as you wish without any limitations.

Personalised recommendations

A select list of articles that match your interests and tastes.

Faster pages

Move smoothly between articles as our pages load instantly.


A one-stop-shop for seeing the latest updates, and managing your preferences.


We brief you on the latest and most important developments, three times a day.

Support Quality Journalism.

*Our Digital Subscription plans do not currently include the e-paper, crossword and print.

Source link

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button