1 hr ago
Glenmark Goa Facility Receives VAI Status After FDA Inspection
Glenmark makes medicines at a factory in Goa.
The US Food and Drug Administration inspected that factory.
The inspection happened from June 22 to June 30.
The FDA gave the factory a report called an Establishment Inspection Report.
It classified the inspection as Voluntary Action Indicated, or VAI.
This means the FDA saw some issues but did not recommend formal regulatory action.
Glenmark is expected to address the issues voluntarily.
The company did not say exactly what the issues or fixes were, and its shares rose slightly after the announcement.
Glenmark Pharmaceuticals received an Establishment Inspection Report from the US Food and Drug Administration for its Goa formulations facility.
The inspection received a Voluntary Action Indicated classification, meaning the FDA observed objectionable conditions but did not recommend regulatory action.
The FDA inspection took place from June 22 to June 30.
Glenmark did not disclose specific observations or corrective actions in its regulatory filing.
Glenmark shares rose 0.28% to Rs 2,470, from a previous close of Rs 2,463.
- Who
- Glenmark Pharmaceuticals and the US Food and Drug Administration.
- What
- The FDA issued an Establishment Inspection Report for Glenmark’s Goa formulations facility with a Voluntary Action Indicated status.
- Where
- Glenmark’s formulations manufacturing facility in Goa, India.
- When
- The inspection took place from June 22 to June 30; Glenmark announced the outcome on September 23, 2026.
- Why
- The FDA issued the report after completing its inspection; the VAI status indicates that voluntary corrective measures are expected.
Key facts
- Company
- Glenmark Pharmaceuticals Ltd
- Facility
- Formulations manufacturing facility in Goa, India
- Regulator
- US Food and Drug Administration
- Inspection period
- June 22 to June 30
- Inspection outcome
- Establishment Inspection Report with Voluntary Action Indicated status
- Share price reaction
- Shares rose 0.28% to Rs 2,470 from Rs 2,463
- Global presence
- More than 80 countries
Quotes
Glenmark Pharmaceuticals
Pharmaceutical company issuing the regulatory disclosure
“Glenmark Pharma 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.”
businesstoday.in
Sources
Related news
Cipla’s InvaGen Plant Gets USFDA VAI Classification for Inspection
US FDA Inspection Finds Three Observations at Apitoria Plant
USFDA Warns Reliance Life Sciences Over Navi Mumbai Drug Lapses
Aurobindo Pharma’s US Unit Reports Four FDA Observations
Dr Reddy’s Mexico API Facility Gets Two USFDA Observations
Bombay High Court Rebukes FDA, Cipla Licence Order Withdrawn
Experimental non-hormonal endometriosis drug enters early safety testing
GLP-1 Drugmakers Face US Lawsuits Over Rare Blindness Risk
Maharashtra FDA Seizes Adulterated Food Worth Rs 1.36 Crore
Sensex Jumps 564 Points as Nifty Clears 23,400
