Sun’s factory is under Import Alert until it becomes compliant with FDA and cGMP standards, while Hikal was hit with a warning letter due to repeated metal contamination.
Despite industry setbacks with adeno associated virus-based gene therapy programs, the issue is “largely overblown” for Repligen, contend Leerink Partners analysts.
Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
William Blair analysts contend the Swiss-headquartered CDMO has a leading position in the attractive, but often underappreciated, small-molecule drug manufacturing space.
The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.
Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?
The India-based CDMO’s 80,000 square-foot facility in Hopewell, New Jersey includes drug substance manufacturing suites, laboratories, storage, dispensing and warehousing.
The family-owned business is expanding capacity for handling complex injectables, while positioning for growth in drug product development, device assembly and packaging.
Having an effective strategy so products remain free from contaminants is essential to pharmaceutical manufacturing to prevent delays, product recalls, and patient harm.
A second report in as many weeks makes the case that Indian CRDMOs are positioned to take advantage of a global supply chain shakeup and Chinese firms stand to lose.
In a cabinet meeting, President Trump ratcheted up pressure on drugmakers as HHS Secretary Robert F. Kennedy Jr. said his department is “deep” into MFN negotiations.
Of about $350 billion in U.S. investments announced in 2025, approximately half of the capital expenditures were previously planned or have already occurred, finds CBRE.
While Jefferies analysts predict Cohance Lifesciences is poised to achieve the highest growth rate among Indian firms, Sai Life Sciences is their top pick in the sector.
This week, J&J pledged $2 billion to establish a 160,000-square-foot facility at contract manufacturer Fujifilm Biotechnologies’ new biomanufacturing site in North Carolina.
Climate change-driven extreme weather events threaten the pharmaceutical supply chain in the U.S., with 62.8% of facilities in disaster-prone counties, finds new research.
William Blair analysts have initiated coverage of Thermo Fisher and expect the company to build on its status as the “partner of choice” for the biopharma industry.
Outsourced R&D and manufacturing offers substantial cost efficiency, driven by specialized expertise, economies of scale, and access to skilled talent, finds Ind-Ra.
Stockpiling active pharmaceutical ingredients for critical drugs is prudent. However, domestic production of prioritized auxiliary chemicals must be part of strategy.
The Assistant Secretary for Preparedness and Response must come up with a list of approximately 26 drugs, secure a six-month supply, and prioritize domestic sourcing.
The industry’s robotics market showed the strongest sector growth in the second quarter of 2025, according to new data from the Association for Advancing Automation.
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.
The contract manufacturer has 11 late-stage projects with commercial approval potential within the next few years, including a developer of GLP-1 therapeutics for obesity.
President Donald Trump’s playbook is to threaten outrageously high industry-specific tariffs in the hope of pressuring drugmakers to come running back to this country.
The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.
President Trump told CNBC his administration would initially levy a “small” pharma-specific tariff, followed by an increase to 150% in a year or so and then as high as 250%.
While the facility has had several run-ins in recent years with U.S. regulators, selling the site is part of Lilly’s broader global manufacturing strategy.
The Bloomington, Indiana facility is a fill-finish site for Regeneron’s Eylea HD and odronextamab and handles the final stages of drug preparation and packaging.
The agreement includes a 15% tariff on branded pharmaceutical products imported from the European Union to the United States, elevating costs across the pharma value chain.