Regulatory

Briefs: Glenmark Pharma, Dishman Carbogen Amcis and Piramal Pharma

Glenmark Pharma clears USFDA audit for Goa plant with VAI status

  • By IPP Bureau | September 23, 2026

Glenmark Pharma clears USFDA audit for Goa plant with VAI status

Glenmark Pharmaceuticals Ltd (Glenmark), a research-led, global pharmaceutical company today announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for its formulations manufacturing facility in Goa, India with a Voluntary Action Indicated (VAI) status. The inspection was conducted at the company’s manufacturing facility from June 22, 2026, to June 30, 2026.

Dishman Carbogen Amcis subsidiary passes USFDA inspection with zero observations

Dishman Carbogen Amcis Limited's wholly owned Swiss subsidiary, Carbogen Amcis, has completed its first U.S. FDA inspection at its Vionnaz manufacturing site with zero observations. This clean inspection outcome provides crucial regulatory validation as the parent company navigates a challenging financial year.

Piramal Pharma Morpeth facility faces seven observations from USFDA inspection

Piramal Pharma Limited has announced that its Morpeth facility in the UK recently underwent a US FDA inspection. The Good Manufacturing Practices audit concluded with the issuance of a Form-483 containing seven observations. The company is currently addressing these requirements and preparing a comprehensive response.

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