Glenmark Addresses USFDA Inspection Observations

  Published 9 months ago

USFDA inspected Glenmark's Monroe site (June 9-17, 2025) and issued a Form 483 with five procedural observations; the company is to respond promptly, and no data integrity issues.

  • USFDA conducted a June 9-17, 2025, GMP inspection at the Monroe site, issuing Form 483.
  • Five procedural observations noted; none relate to data integrity, per Glenmark.
  • The company is to collaborate with the USFDA, submit a response within the timeline, and ensure compliance.

You might like these

RBI Updates Rupee IRD Rules for Market Alignment

AI Shakes Ad Giants: Publicis & WPP Shares Fall

India's Oilmeal Exports Rise 4% in May 2025

Tata Motors Slips Ahead of Q1 Results

India's Bond Yields Rise Amid RBI Rate Cuts and Policy Shifts

Sula Revenue Stable, Profit Falls

Coal India Q1 PBT Drops 17%

News that matters the most ⚡