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1627 News Found

Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

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
Drug Approval | June 28, 2024

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
Drug Approval | June 25, 2024

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
News | June 24, 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
Drug Approval | June 24, 2024

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
Drug Approval | June 19, 2024

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


Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility
Drug Approval | June 13, 2024

Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility

There was no observation related to data integrity reported


Aurigene Pharmaceutical opens biologics facility in Genome Valley, Hyderabad
News | June 04, 2024

Aurigene Pharmaceutical opens biologics facility in Genome Valley, Hyderabad

The state-of-the-art facility is equipped with best-in-class equipment and control systems


Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US
News | June 03, 2024

Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US

Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025