September 2025 — CDMO Opportunities And Threats Report
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.
| Contractor | BioPharma Company | Event | Product | Relationship |
POTENTIALLY POSITIVE |
||||
| Almac Group Ltd | Tonix Pharmaceuticals Inc; | FDA approval | Tonmya | Solid dose manufacturer |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Akero Therapeutics Inc | Positive Phase II Final results | efruxifermin | Biological API |
| BSP Pharmaceuticals SpA | Johnson & Johnson | FDA approval | Inlexzo | Parenteral manufacturer |
| Corden Pharma International GmbH | Madrigal Pharmaceuticals Inc; | EMA approval | Rezdiffra | Solid dose manufacture & packaging |
| Corden Pharma International GmbH | Johnson & Johnson | FDA approval | Inlexzo | Parenteral manufacturer |
| Corden Pharma International GmbH | Viking Therapeutics Inc | Positive Phase II top-line results | VK-2735 | Biological API |
| Corden Pharma International GmbH | Viking Therapeutics Inc | Positive Phase II top-line results | VK-2735 | Parenteral manufacturer |
| Flamma SpA | Genzyme Corp | FDA approval | Wayrilz | Small mol API |
| Fujifilm Diosynth Biotechnologies Uk Ltd | Novavax Inc | FDA expanded indications | Nuvaxovid | Biological API |
| Par Sterile Products LLC | Novavax Inc | FDA expanded indications | Nuvaxovid | Parenteral manufacture & packaging |
| PCI Pharma Services | Johnson & Johnson | FDA approval | Inlexzo | Parenteral manufacturer |
| Unither Pharmaceuticals SAS | Thea Pharma Inc | FDA approval | Zolymbus | Solid dose manufacturer |
| ACS Dobfar SpA | Pfizer Ltd | UK MHRA approval | Zavicefta | Parenteral manufacture & packaging |
| AstraZeneca Plc | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| AstraZeneca Plc | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| Baxter International Inc | Baxalta Inc | FDA expanded indications | Vonvendi | Biological API |
| Biogen Inc | Johnson & Johnson | NICE approval | Tremfya | Biological API |
| Biogen Inc | Johnson & Johnson | NICE approval | Tremfya | Biological API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | NICE approval | Keytruda | Biological API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca Plc | NICE approval | Imfinzi | Biological API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca Plc | NICE approval | Imjudo | Biological API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca UK Ltd | UK MHRA expanded indications | Imfinzi | Biological API |
| Bora Pharmaceuticals Co Ltd | Novavax Inc | FDA expanded indications | Nuvaxovid | Parenteral manufacturer |
| BSP Pharmaceuticals SpA | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| BSP Pharmaceuticals SpA | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| C3i Center Inc | Cordex Biologics Inc | EMA approval | Zemcelpro | Biological API |
| Catalent CTS LLC | Janssen-Cilag Ltd | UK MHRA expanded indications | Imbruvica | Solid dose manufacture & packaging |
| Catalent CTS LLC | Johnson & Johnson | FDA approval | Inlexzo | Parenteral manufacturer |
| Catalent Inc | Neurizon Therapeutics Ltd | Positive Phase I top-line results | monepantel | Small mol API |
| Corden Pharma International GmbH | Eli Lilly and Co | NICE approval | Mounjaro | Biological API |
| Corden Pharma International GmbH | Eli Lilly and Co | NICE approval | Mounjaro | Biological API |
| Curia Global Inc | Tryp Therapeutics Inc | Trial planned - Phase I | TRP-8803 | Small mol API |
| Fareva SA | Foresee Pharmaceuticals Co Ltd; | FDA expanded indications | Camcevi ETM | Parenteral manufacturer |
| GSK plc | Novavax Inc | FDA expanded indications | Nuvaxovid | Parenteral manufacture & packaging |
| Kymos Pharma Services SL | Polpharma SA | EMA approval | Eiyzey | Parenteral manufacturer |
| Lonza Group Ltd | Astellas Pharma Inc | NICE approval | Padcev | Biological API |
| Mabion SA | Novavax Inc | FDA expanded indications | Nuvaxovid | Biological API |
| MIAS Pharma Ltd | SpringWorks Therapeutics Inc; | EMA approval | Ogsiveo | Solid dose manufacturer |
| Mycenax Biotech Inc | Polpharma SA | EMA approval | Eiyzey | Biological API |
| Novo Nordisk AS | Kyowa Kirin Co Ltd | NICE approval | Fasenra | Parenteral manufacture & packaging |
| Novo Nordisk AS | pharmaand GmbH | UK MHRA expanded indications | Pegasys | Parenteral manufacture & packaging |
| Organon & Co | Merck & Co Inc | NICE approval | Keytruda | Parenteral manufacture & packaging |
| Organon & Co | Merck & Co Inc | NICE approval | Keytruda | Parenteral manufacture & packaging |
| Patheon NV | Tonix Pharmaceuticals Inc; | FDA approval | Tonmya | Solid dose manufacturer |
| Patheon NV | Genzyme Corp | FDA approval | Wayrilz | Solid dose manufacture & packaging |
| Patheon NV | AstraZeneca Pharmaceuticals LP | FDA expanded indications | Koselugo | Solid dose manufacturer |
| Patheon NV | Novo Nordisk Inc | FDA expanded indications | Wegovy | Parenteral Packaging |
| PCI Pharma Services | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | Johnson & Johnson | NICE approval | Tremfya | Parenteral Packaging |
| PCI Pharma Services | Johnson & Johnson | NICE approval | Tremfya | Parenteral Packaging |
| PCI Pharma Services | Janssen-Cilag Ltd | UK MHRA expanded indications | Imbruvica | Solid dose packaging |
| Samsung Biologics Co Ltd | AstraZeneca Plc | NICE approval | Imfinzi | Biological API |
| Samsung Biologics Co Ltd | AstraZeneca UK Ltd | UK MHRA expanded indications | Imfinzi | Biological API |
| Sharp Packaging Services LLC | BeOne Medicines Ltd | EMA expanded indications | Tevimbra | Parenteral Packaging |
| Sharp Packaging Services LLC | BeOne Medicines Ltd | Positive Phase III top-line results | Tevimbra | Parenteral Packaging |
| Shilpa Medicare Ltd | Johnson & Johnson | FDA approval | Inlexzo | Parenteral manufacturer |
| Siegfried Holding AG | Chiesi Farmaceutici SpA | NICE approval | Raxone | Solid dose packaging |
| Siegfried Holding AG | Novavax Inc | FDA expanded indications | Nuvaxovid | Parenteral manufacture & packaging |
| Siegfried Holding AG | Baxalta Inc | FDA expanded indications | Vonvendi | Parenteral manufacturer |
| Simtra US LLC | Astellas Pharma Inc | NICE approval | Padcev | Parenteral manufacture & packaging |
| Simtra US LLC | Novavax Inc | FDA expanded indications | Nuvaxovid | Parenteral manufacturer |
| SK Bioscience Ltd | Novavax Inc | FDA expanded indications | Nuvaxovid | Biological API |
| UPM Pharmaceuticals Inc | Madrigal Pharmaceuticals Inc; | EMA approval | Rezdiffra | Solid dose manufacturer |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | NICE approval | Mounjaro | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | NICE approval | Imfinzi | Parenteral manufacturer |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca UK Ltd | UK MHRA expanded indications | Imfinzi | Parenteral manufacturer |
| Woodstock Sterile Solutions, 2210 Lake Shore Drive, Woodstock, Illinois, United States | American Genomics LLC; | FDA approval | Cyklx | Sterile liquid manufacture |
| WuXi STA (Shanghai) Co Ltd | Janssen-Cilag Ltd | UK MHRA expanded indications | Imbruvica | Small mol API |
| WuXi XDC Cayman Inc | Janssen-Cilag Ltd | UK MHRA expanded indications | Imbruvica | Small mol API |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
EMA = European Medicines Agency; NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold
** Denotes product being marketed or in the pipeline for COVID-19 therapy area