
USFDA11 Sept 2026, 10:10 pm
Dr Reddy's Mexico Facility Undergoes USFDA Records Assessment
AI Summary
Dr. Reddy's Laboratories announced that its API manufacturing facility in Mexico, Industrias Químicas Falcón de México, S.A. de C.V., recently underwent a records assessment by the United States Food and Drug Administration (USFDA). The assessment, conducted between July 17, 2026, and September 8, 2026, concluded with the issuance of a Form FDA 2953, which included two observations. Dr. Reddy's stated that it will respond to these observations within the stipulated timeline. This disclosure is made in accordance with SEBI (LODR) Regulations, 2015.
Key Highlights
- USFDA conducted records assessment at Dr. Reddy's Mexico API facility.
- Assessment period was from July 17, 2026, to September 8, 2026.
- USFDA issued Form FDA 2953 with two observations.
- Company will respond to observations within the stipulated timeline.
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