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Results For "GMP"

507 News Found

Cipla Patalganga facility gets 6 USFDA observations
Drug Approval | April 07, 2024

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.


Aragen operationalizes first phase of its US$ 30 million Biologics manufacturing facility in India
News | March 30, 2024

Aragen operationalizes first phase of its US$ 30 million Biologics manufacturing facility in India

Executes the first project for developing and manufacturing a novel anticancer mAb


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


Merck invests € 300 million in new Life Science production site in South Korea
News | March 21, 2024

Merck invests € 300 million in new Life Science production site in South Korea

New Bioprocessing Production Center in Daejeon to supply products to customers in Asia-Pacific for development and production of biologics


Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


Grace expands CDMO capacity by 25% of South Haven facility in Michigan
News | March 19, 2024

Grace expands CDMO capacity by 25% of South Haven facility in Michigan

Additional capacity broadens Grace’s fine chemical capabilities for API production


Evonik makes five generations healthier with EUDRAGIT coatings for targeted drug delivery
News | March 16, 2024

Evonik makes five generations healthier with EUDRAGIT coatings for targeted drug delivery

More than 10,000 scientific publications containing EUDRAGIT


Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility
Drug Approval | March 16, 2024

Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility

The company is confident of addressing the concern raised by the USFDA