Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

FDA concludes Lupin’s Nagpur Unit-1 facility inspection with zero observations

Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively