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2853 News Found

Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


AbbVie to invest $195 million to expand API manufacturing in North Chicago
News | August 16, 2025

AbbVie to invest $195 million to expand API manufacturing in North Chicago

The new facility will enhance AbbVie’s chemical synthesis capacity to support domestic production of current and next-generation neuroscience, immunology, and oncology medicines


Bristol Myers Squibb and Bain Capital launch biotech company NewCo
News | July 31, 2025

Bristol Myers Squibb and Bain Capital launch biotech company NewCo

NewCo’s pipeline includes five investigational medicines


Fortis and Agilus expand rapid genomic testing capabilities
Biotech | July 31, 2025

Fortis and Agilus expand rapid genomic testing capabilities

The Genexus platform enables Next-Generation Sequencing with significantly faster turnaround times


RPG Life Sciences appoints Deepak Shukla as Chief Executive - API Business
People | July 27, 2025

RPG Life Sciences appoints Deepak Shukla as Chief Executive - API Business

Deepak has around 25 years of work experience with reputed companies viz. UPL Group, Teva Group, AkzoNobel India, Ranbaxy Laboratories, and Dr. Reddy’s Laboratories


Concord Biotech successfully completes Russian GMP inspection at its API facility
Drug Approval | July 27, 2025

Concord Biotech successfully completes Russian GMP inspection at its API facility

The inspection was conducted from July 22-25, 2025


48 projects approved under PLI Scheme for promotion of domestic manufacturing of critical KSMs/DIs/APIs
Policy | July 24, 2025

48 projects approved under PLI Scheme for promotion of domestic manufacturing of critical KSMs/DIs/APIs

The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs


NATCO Pharma API unit in Mekaguda receives EIR from USFDA
Drug Approval | July 24, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483