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Results For "quality-standards"

165 News Found

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech
News | September 12, 2024

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility


Vaishali Pharma Ltd recommends 1:1 bonus issue and 1:5 stock split
News | August 30, 2024

Vaishali Pharma Ltd recommends 1:1 bonus issue and 1:5 stock split

The company is making its mark through strategic initiatives, promising to become a significant presence in the evolving pharmaceutical sector


BI Sky Global successfully completes FDA MoCRA registration
Drug Approval | August 25, 2024

BI Sky Global successfully completes FDA MoCRA registration

MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States


Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
News | July 10, 2024

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection

The Unit has been issued GMP Certification from ANVISA-Brazil


Melissa Seymour to join Lilly as executive vice president of Global Quality
People | June 06, 2024

Melissa Seymour to join Lilly as executive vice president of Global Quality

Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry


Melissa Seymour to join Lilly as executive vice president of Global Quality
People | June 06, 2024

Melissa Seymour to join Lilly as executive vice president of Global Quality

Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.


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


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