April 20, 2026: Indian pharmaceutical majors Lupin and Cipla are in focus after inspections by the U.S. Food and Drug Administration (USFDA) resulted in observations related to manufacturing practices.
Lupin receives Form 483 for US facility
Lupin’s manufacturing facility in Somerset, New Jersey, has been issued a Form 483 by the USFDA following a recent inspection.
Key details:
- The notice highlights three observations where the facility may not fully comply with US drug safety norms
- A Form 483 is issued when inspectors identify potential deviations from Good Manufacturing Practices (GMP)
Company response:
Lupin stated that it is reviewing the observations and will respond to the USFDA within the stipulated timeline. The company reiterated its commitment to maintaining high manufacturing and compliance standards.
Cipla gets two observations after Goa inspection
Separately, Cipla announced that the USFDA conducted an inspection at its Goa manufacturing facility (Verna) from April 6 to April 17, 2026.
Inspection scope:
- Routine current Good Manufacturing Practices (cGMP) review
- Pre-Approval Inspection (PAI)
Outcome:
- The company received two observations in Form 483
Company response:
Cipla said it will work closely with the USFDA to address the observations comprehensively within the required timeframe.
