Dr. Reddy’s Laboratories announced that the United States Food and Drug Administration (USFDA) has completed a records assessment at its API manufacturing facility in Mexico. The assessment, conducted between July 17, 2026, and September 8, 2026, resulted in two observations. Dr. Reddy’s will provide a response to these observations within the stipulated timeline.
USFDA Assessment Concludes at Mexico Facility
Dr. Reddy’s Laboratories Ltd. has disclosed that the United States Food and Drug Administration (USFDA) has concluded its records assessment at the company’s API manufacturing facility located in Jiutepec, Morelos, Mexico. This facility is operated by Industrias Químicas Falcón de México, S.A. de C.V. (Dr. Reddy’s Mexico).
Assessment Details and Observations
The assessment was conducted over a period spanning from July 17, 2026, to September 8, 2026. Following the conclusion of this review, the USFDA issued a Form FDA 2953, which included two observations. Dr. Reddy’s Laboratories has confirmed that it will respond to these observations within the timeframe specified by the regulatory body.
This disclosure is made for the information and records of stakeholders.
Source: BSE
