Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations

The USFDA inspected Lupin's Pithampur Unit-1 API and finished product manufacturing facility from September 16 to September 27, 2024. The inspection closed with three observations each on the API and Finished Product side. The company is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe.

USFDA inspection at Alembic’s oral solid formulation facility at Panelav

Alembic Pharmaceuticals Limited has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection carried out by them at our Oral Solid Formulation Facility (F-I) from 17th July, 2024 to 26th July, 2024.

Piramal Pharma

USFDA Inspection at Piramal Pharma Limited’s manufacturing facility located at Ahmedabad, India, with Zero Form - 483 observations and No Action Indicated (NAI) designation. In furtherance to the aforementioned intimation, the company has informed that the USFDA has issued an EIR for the said manufacturing facility. Receipt of said EIR marks formal closure of the inspection.