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Results For "manufacturing-facility"

631 News Found

EMA approves Biocon Biologics’ new mAbs facility in India
News | June 24, 2024

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites


Cipla gets 6 observations from USFDA for Goa facility
Drug Approval | June 24, 2024

Cipla gets 6 observations from USFDA for Goa facility

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time


Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets
Drug Approval | June 14, 2024

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).


Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility
Drug Approval | June 13, 2024

Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility

There was no observation related to data integrity reported


Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Drug Approval | June 07, 2024

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus


Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US
News | June 03, 2024

Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US

Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025


Valent BioSciences opens new addition at Melnik and Shafer Biorational Research Center
News | May 30, 2024

Valent BioSciences opens new addition at Melnik and Shafer Biorational Research Center

Greg was also central to the planning, design, and construction of this facility


Lilly increases manufacturing investment to US$ 9 billion at newest Indiana site
News | May 29, 2024

Lilly increases manufacturing investment to US$ 9 billion at newest Indiana site

Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease