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Results For "regulatory"

1216 News Found

Novartis to invest $23 billion on expansion of manufacturing and R&D facilities in US
News | April 14, 2025

Novartis to invest $23 billion on expansion of manufacturing and R&D facilities in US

Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities


West Bengal Chemical Industries receives National IP Award 2024
News | April 14, 2025

West Bengal Chemical Industries receives National IP Award 2024

The National IP Awards recognize outstanding contributions to India’s innovation economy through effective IP creation and commercialization


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older


Nureca’s manufacturing subsidiary secures USFDA registration
News | April 14, 2025

Nureca’s manufacturing subsidiary secures USFDA registration

This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States


OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru
Drug Approval | April 11, 2025

OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru

This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance


Zeon Lifesciences appoints GK Sharma as Group Technical Director
People | April 11, 2025

Zeon Lifesciences appoints GK Sharma as Group Technical Director

Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables


Sanofi India MD Rodolfo Hrosz to step down on April 30
People | April 11, 2025

Sanofi India MD Rodolfo Hrosz to step down on April 30

The board of directors accepted Hrosz’s resignation and expressed appreciation for his significant contributions during his tenure


Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Drug Approval | April 09, 2025

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites


ZIM Laboratories and Globalpharma collaborate to commercialize oral thin film products in GCC
News | April 09, 2025

ZIM Laboratories and Globalpharma collaborate to commercialize oral thin film products in GCC

This partnership encompasses dossier licensing, bulk product supply, and the licensing of ZIM Labs’ proprietary Oral Thin Film technology platform, ThinOral


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets