Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity

Piramal Pharma’s Ahmedabad facility completes USFDA PAI

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions

Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated

Lupin receives EIR from US FDA for its Somerset manufacturing facility

The facility was inspected from May 7 to May 17, 2024

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites

Cipla gets 6 observations from USFDA for Goa facility

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations