FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

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

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025

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

The inspection concluded with zero form 483 observations

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483