USFDA Conducts Inspection At Manufacturing Facility Of Lupin, Alembic And Piramal Pharma

Lupin's Pithampur Unit-1 has received a Form 483 from the USFDA that includes three observations: The US FDA inspected Lupin's Pithampur Unit-1, which produces APIs as well as finished products, from September 16 to September 27, 2024. The inspection led to the US FDA raising three observations for both the API and the finished product divisions. The company is taking extensive measures to answer the observations raised by the USFDA and submitting their reply within the stipulated time frame.

Inspection by the USFDA at Alembic’s oral solid formulation facility in Panelav: Alembic Pharmaceuticals Limited received an (Establishment Inspection Report) EIR from the US FDA following the inspection of the Oral Solid Formulation Facility (F-I) that took place from 17 to 26 July 2024.

Inspection by the USFDA at the manufacturing facility of Piramal Pharma Limited in Ahmedabad, India: The US FDA inspected the manufacturing facility of Piramal Pharma Limited in Ahmedabad, India, without any Form 483 observations and classified it as NAI (No Action Indicated). After this update, the company was informed that the US FDA has issued the EIR (Establishment Inspection Report) for the facility, thus officially closing the inspection.