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You Searched For "form 483"
Biocon Receives 5 USFDA Observations at Bengaluru Biosimilars Site

Biocon Receives 5 USFDA Observations at Bengaluru Biosimilars Site

Written By Parthika Patel30 April 2026 7:52 PM IST
New Delhi: Biocon Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at...
Supriya Lifescience Secures USFDA EIR With VAI Status for Lote API Facility

Supriya Lifescience Secures USFDA EIR With VAI Status for Lote API Facility

Written By MD Bureau23 April 2026 11:00 AM IST
New Delhi: Active pharmaceutical ingredients (API) manufacturer Supriya Lifescience on Wednesday announced that the USFDA has issued an Establishment...
Ajanta Pharma

Ajanta Pharma Gets 5 USFDA Observations for Paithan Facility

Written By Parthika Patel22 April 2026 12:30 PM IST
New Delhi: Ajanta Pharma Limited has informed that the US Food and Drug Administration (USFDA) has completed its inspection of its manufacturing...
Cipla Gets 2 USFDA Observations for Goa Facility

Cipla's Goa Plant Gets 2 USFDA Observations After cGMP, Pre-Approval Inspection

Written By Parthika Patel18 April 2026 7:53 PM IST
New Delhi: Cipla Limited has informed that the United States Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing...
Aarti Pharmalabs Gets Single Observation in USFDA Inspection at Tarapur Unit

Aarti Pharmalabs Gets 1 Observation in USFDA Inspection at Tarapur Unit

Written By Parthika Patel30 March 2026 1:00 PM IST
Mumbai: Aarti Pharmalabs Limited has successfully completed an inspection by the United States Food and Drug Administration (USFDA) at its Unit-IV...
Aurobindo Arm CuraTeQ Partners STADA Arzneimittel AG to Commercialise Biosimilars in Europe

USFDA Flags Aurobindo's Eugia Unit-II with OAI Status After Bhiwadi Inspection

Written By Parthika Patel19 March 2026 11:30 PM IST
Hyderabad: Aurobindo Pharma Limited has recently informed that the United States Food and Drug Administration (USFDA) has classified Unit-II of its...
Zydus

Zydus Unit 9 Clears USFDA Pre-Approval Inspection at Changodar Facility

Written By sheeba farhat20 Feb 2026 10:21 PM IST
Ahmedabad: Zydus Lifesciences Limited has successfully cleared a Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration...
Aurobindo Pharma Gets USFDA Nod for Generic Ravicti to Treat Urea Cycle Disorders

USFDA Flags 9 Observations at Aurobindo's Telangana Unit Over Quality, Contamination Risks

Written By Parthika Patel18 Feb 2026 11:46 PM IST
New Delhi: The United States Food and Drug Administration (USFDA) has raised multiple concerns regarding manufacturing practices, documentation...
Alkem labs slapped rs 333 cr tax demand

Alkem's Enzene Unit Gets 6 USFDA Observations

Written By Parthika Patel16 Feb 2026 3:30 PM IST
New Delhi: Alkem Laboratories Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval...
Lupin Gets USFDA Approval for Xigduo XR Generic Dapagliflozin-Metformin Tablets

Lupin Gets Zero USFDA Observations for Nagpur Plant

Written By sheeba farhat15 Feb 2026 11:30 AM IST
Mumbai: Lupin Limited has announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Nagpur...
Cipla

USFDA Concludes PAI at Cipla Subsidiary InvaGen With 2 Observations

Written By Parthika Patel13 Feb 2026 12:30 PM IST
New Delhi: Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval...
Aurobindo Pharma Gets USFDA Nod for OTC Dextromethorphan Polistirex ER Suspension

USFDA Issues 9 Observations to Aurobindo's Jedcherla Unit-VII After Inspection

Written By Parthika Patel12 Feb 2026 11:44 PM IST
New Delhi: Aurobindo Pharma Limited recently informed that the United States Food and Drug Administration (USFDA) has completed an inspection at its...
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