HYDERABAD: Pharma major Dr Reddy’s Laboratories on Saturday said its active pharmaceutical ingredients manufacturing facility ...

CHENNAI: Shares of Hyderabad-based drug maker Dr. Reddy's Laboratories Ltd. are in the spotlight today following a regulatory ...

Dr Reddy's Laboratories received two observations from the USFDA following an inspection of its API facility in New York. The ...

Dr Reddy's Laboratories receives Form 483 with two observations from US health regulator after facility inspection.

We are in the process of drafting a very robust response to each of the observations in the Form 483. According to Equirius, the unit received Form 483 with 12 observation that runs through 38 pages.

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at ...

Empower initially received the less severe consequence of a Form 483 and started a recall of certain products made at the facility following the FDA’s inspection last summer. That said ...

"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the ...

Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has issued two ...

"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...

2016 and issued six observations in Form 483. The US drug regulator issued the observations for its oncology formulation facility at Duvvuda in Visakhapatnam‘s SEZ. The site is important given ...