FEATURE ARTICLES
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
- From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Where Contamination Control Really Breaks Down In Practice
- Trends In FDA FY 2025 Warning Letters
- Raising The Bar In Radiopharmaceutical Manufacturing
- SUS Interchangeability Assessment And Qualification Best Practices
PHARMA ONLINE WHITE PAPERS
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![getty-1311598658-data-analytics]( "Exploring Agentic AI In GMP Operations")
Exploring Agentic AI In GMP OperationsDiscover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.
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Enabling CDMOs To Focus On Core Priorities4/26/2024
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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Incremental Adoption Of A Modular Operations Platform1/31/2025
Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
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5 Steps To Design A Microbiological Performance Qualification For Facilities4/21/2025Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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Pharmaceutical Spray Drying – Technology And Applications1/21/2025
Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells6/28/2024
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 03.21.26 -- Software Product Showcase
- 03.20.26 -- SUS Interchangeability Assessment And Qualification Best Practices
- 03.19.26 -- From Control To Intelligence: The Evolution Of GMP Asset Management
- 03.19.26 -- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- 03.19.26 -- STREAM Edition: Closer To Home: Rethinking API Manufacturing
INDUSTRY NEWS
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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Axplora Announces $60 Million High Potency API Manufacturing Facility Expansion In Italy3/17/2026
Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.
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BD Announces $110 Million To Support U.S. Pharmaceutical Supply Chain For Biologic Drugs3/16/2026
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a $110 million investment to expand its production of prefillable syringes, helping accelerate biologic and GLP-1 drug delivery and supporting pharmaceutical reshoring in the U.S.
