Briefs: Dr. Reddy's Laboratories
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Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

  • By IPP Bureau | May 06, 2023

Dr. Reddy's Laboratories updates on USFDA GMP inspection at Bollaram unit

Dr. Reddy's Laboratories has announced that the United States Food & Drug Administration (USFDA) today completed a routine GMP inspection at our API manufacturing facility (CTO 1) in Bollaram, Hyderabad. The inspection was conducted from 1st May, 2023 to 5th May, 2023. We have been issued a Form 483 with one observation, which we will address within the stipulated timeline.

Dr. Reddy's Laboratories announces the launch of Regadenoson Injection 0.4 mg/5 mL in the US

Dr. Reddy's Laboratories announced the launch of Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan® (Regadenoson) injection, approved by U. S. Food and Drug Administration (USFDA). Dr. Reddy's Regadenoson Injection is supplied as single-dose pre-filled syringes, 0.4 mg/5 mL (0.08 mg/mL).

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