Drug Approval | July 26, 2024
USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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€ 6.6 million investment at Nantong site expands production capabilities for cell culture media
Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
Renews GMP certifications for India and Malaysia sites
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
The company is committed to address this observation comprehensively within stipulated time
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
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