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6 announcements with these filters
Dr Reddy's says USFDA closed its PAI and GMP inspection at Srikakulam FTO-SEZ Process Unit-02 with VAI classification. The outcome is closed with no monetary penalty.
Dr. Reddy's Laboratories received a USFDA Form 483 with two observations following a Pre-Approval Inspection at its Pydibhimavaram facility. The company plans to address these observations within the stipulated timeline.
Dr. Reddy's Laboratories received two observations from the USFDA following a records assessment of its API manufacturing facility in Jiutepec, Mexico.
Dr. Reddy's Laboratories has terminated its distribution and promotion agreement with Novartis India Limited following a change in NIL's controlling shareholding.
Dr. Reddy's Laboratories received a Form 483 with three observations following a USFDA inspection at its Srikakulam FTO-SEZ unit, which the company will address.
USFDA completed a pre-license inspection at Dr Reddy's Bachupally facility. The company received a Form 483 with seven observations.