News about "United States Food and Drug Administration (USFDA)"

USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification

USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification

Dr. Reddy’s Laboratories has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.

United States Food And Drug Administration (USFDA) | 21/10/2025 | By Dineshwori 135

Zydus Receives USFDA Approval for Deflazacort Oral Suspension

Zydus Receives USFDA Approval for Deflazacort Oral Suspension

Zydus stated that deflazacort oral suspension will be produced at Doppel, Italy.

United States Food And Drug Administration (USFDA) | 06/10/2025 | By Dineshwori

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

The United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at Cohance Lifesciences' API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.

United States Food And Drug Administration (USFDA) | 12/09/2025 | By Dineshwori 212

Unichem Receives EIR with VAI Status from USFDA for Roha API Facility

Unichem Receives EIR with VAI Status from USFDA for Roha API Facility

Unichem Laboratories has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Roha active pharmaceutical ingredients (API) facility.

United States Food And Drug Administration (USFDA) | 27/08/2025 | By Dineshwori 156


 

 

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