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Results For "Voluntary-Action-Indicated"

55 News Found

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
Drug Approval | November 29, 2025

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States


Glenmark Pharma gets VAI from FDA for Monroe facility
Drug Approval | November 27, 2025

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site


Granules India’s facility secures FDA EIR with 'VAI’
Drug Approval | October 30, 2025

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025


Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1
Drug Approval | September 24, 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated


NATCO Pharma API unit in Mekaguda receives EIR from USFDA
Drug Approval | July 24, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally
Drug Approval | July 17, 2025

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards


Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Drug Approval | June 12, 2025

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar


Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma
News | March 20, 2025

Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma

Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA