FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days

Lilly to invest $1.2 billion+ to boost oral medicine manufacturing capacity in US

Company plans to create 100 manufacturing jobs and up to 1,000 construction jobs

Akums breaks ground for its first overseas manufacturing facility in Zambia

It will produce a comprehensive range of dosage forms including tablets, hard gelatin capsules, liquids, injectables, topicals, and beta-lactam products

Cambrex to invest $120 million to expand API manufacturing in US

Expanding US operations to address the increased demand for API development and manufacturing

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta

Merck breaks ground on $3 billion center of excellence for pharma manufacturing in Virginia

The expansion underscores Merck’s commitment to invest more than $70 billion in U.S. research, development and capital projects

Samsung Biologics introduces optimized manufacturing framework ‘ExellenS’

ExellenS applies optimized facility designs, equipment, and processes across all sites to ensure equivalency and speed

AstraZeneca to increase investment in Virginia manufacturing facility to $4.5 billion

Facility marks cornerstone of $50 billion investment in medicines R&D and manufacturing in America

Delhi High Court refuses to restrain Natco from manufacturing spinal muscular atrophy drug

The Court dismissed Swiss drugmaker Roche’s plea for interim injunction