Zydus Unit 9 Clears USFDA Pre-Approval Inspection at Changodar Facility sheeba farhat20 Feb 2026 10:21 PM ISTAhmedabad: Zydus Lifesciences Limited has successfully cleared a Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration...
USFDA Flags 9 Observations at Aurobindo's Telangana Unit Over Quality, Contamination Risks Parthika Patel18 Feb 2026 11:46 PM ISTNew Delhi: The United States Food and Drug Administration (USFDA) has raised multiple concerns regarding manufacturing practices, documentation...
Alkem's Enzene Unit Gets 6 USFDA Observations Parthika Patel16 Feb 2026 3:30 PM ISTNew Delhi: Alkem Laboratories Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval...
Lupin Gets Zero USFDA Observations for Nagpur Plant sheeba farhat15 Feb 2026 11:30 AM ISTMumbai: Lupin Limited has announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Nagpur...
USFDA Concludes PAI at Cipla Subsidiary InvaGen With 2 Observations Parthika Patel13 Feb 2026 12:30 PM ISTNew Delhi: Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval...
USFDA Issues 9 Observations to Aurobindo's Jedcherla Unit-VII After Inspection Parthika Patel12 Feb 2026 11:44 PM ISTNew Delhi: Aurobindo Pharma Limited recently informed that the United States Food and Drug Administration (USFDA) has completed an inspection at its...
Torrent Pharma Gets Zero USFDA Observations for Dahej Plant Parthika Patel25 Jan 2026 11:33 PM ISTNew Delhi: Torrent Pharmaceuticals Limited has informed that the United States Food and Drug Administration (USFDA) has completed an inspection of the...
Cipla's Lanreotide Supply in US Hit After USFDA Observations at Pharmathen Facility Parthika Patel15 Jan 2026 5:46 PM ISTCipla clarified that re-supply of Lanreotide Injection is expected to resume in the first half of FY 2026-27.
Cipla Partner Pharmathen Receives 9 USFDA Observations Farhat Nasim7 Jan 2026 8:22 PM ISTCipla had earlier received final USFDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths.
USFDA Inspection: Alembic Pharma gets form 483 with 5 procedural observations for Gujarat plant Farhat Nasim25 Nov 2024 3:47 PM ISTThe US Food and Drug Administration (USFDA) conducted inspection at Jarod-based solid oral formulation facility.
Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification Farhat Nasim23 Nov 2024 12:49 PM ISTMumbai: Torrent Pharmaceuticals Limited has announced that the company received an Establishment Inspection Report (EIR) from the United States...
USFDA Inspection: Dr Reddy's gets Form 483 with 7 observations for Bollaram facility Farhat Nasim20 Nov 2024 1:48 PM ISTNew Delhi: Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active...
