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Results For "manufacturing-facility"

631 News Found

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
News | December 02, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
Drug Approval | September 21, 2023

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483


Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
News | September 14, 2023

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations


Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million
News | September 02, 2023

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year


Lupin receives EIR from FDA for its API manufacturing facility in Vizag
Drug Approval | June 19, 2023

Lupin receives EIR from FDA for its API manufacturing facility in Vizag

The inspection closed with the facility receiving an inspection classification of NAI


Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Drug Approval | June 16, 2023

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA


Ecolab expands biologics resin manufacturing facility in Pennsylvania
News | June 09, 2023

Ecolab expands biologics resin manufacturing facility in Pennsylvania

New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.


Croda breaks ground on lipid manufacturing facility in Pennsylvania
News | June 09, 2023

Croda breaks ground on lipid manufacturing facility in Pennsylvania

Construction will begin this year with the new capacity anticipated by 2025