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Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA

Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA

Pharma major Dr. Reddy’s Laboratories has received the United States Food and Drug Administration’s (FDA) establishment inspection report for its active pharmaceutical ingredients manufacturing facility (CTO 1) in Bollaram, Hyderabad.

The U.S. FDA inspection, of the plant, was conducted from May 1-5. “The agency has classified the inspection as voluntary action indicated (VAI) and concluded that the inspection is closed under 21 CFR 20.64(d)(3),” the drugmaker said in a filing on Friday. In May, the company had said it was a routine GMP inspection and on completion a Form 483 with one observation was issued.

More news about: quality / gmp | Published by Sudeep Soparkar | August - 08 - 2023 | 820

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