| Listed site | cdmo | cdmo |
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| Summary | Specialist powder-handling CDMO offering clinical trial supply, development, manufacturing, and packaging services for pharmaceutical products. | Purpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities. |
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| Services | - Process Development
- CMC Analytical Development
- Formulation Development
- Inhalation & Nasal Dosage Manufacturing
- Secondary Packaging & Labeling
- Serialization & Track-and-Trace
- Quality Control Testing
- Technology Transfer
- Cold-Chain Storage & Logistics
- Combination Product Assembly & Final Packaging
| - Formulation Development
- Process Development
- CMC Analytical Development
- Technology Transfer
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Inhalation & Nasal Dosage Manufacturing
- Topical & Semi-Solid Manufacturing
- Stability Testing & Storage
- Quality Control Testing
- CMC Regulatory Submission Support
- Combination Product Assembly & Final Packaging
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| Modalities | Data not yet provided. | Data not yet provided. |
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| Indications | Data not yet provided. | Data not yet provided. |
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| Locations | - US Facility, United States
- EU Facility, European Union
- EU Facility, Europe
| - Headquarters, Woodbury, Minnesota, United States
- Bridgeton, Bridgeton, Missouri, United States
- Brentwood, Brentwood, Missouri, United States
- Maryland Heights, Maryland Heights, Maryland, United States
- Northridge, Northridge, California, United States
- Union City, Union City, California, United States
- Lexington, Lexington, Kentucky, United States
- Germantown, Germantown, Maryland, United States
- Loughborough, Loughborough, England, United Kingdom
- Clitheroe, Clitheroe, England, United Kingdom
- Bridgeton, Bridgeton
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| Certifications | - FDA · Identifier: 21 CFR Parts 210, 211, 820
- ICH · Identifier: Q7, Q9, Q10
- EMA · Identifier: EudraLex Volume 4
- ISO · Identifier: 13485:2016
- DEA · Identifier: Schedules I–V
| - FDA · Identifier: cGMP (CFR 210, 211, 820; 21 CFR Part 4)
- ICH · Identifier: ICH Q1A through Q10
- EU · Identifier: Annex 1 compliance
- ISO · Identifier: ISO certifications
- FDA · Identifier: cGMP (CFR 210, CFR 211, CFR 820, 21 CFR Part 4)
- EMA · Identifier: Annex 1 Compliance
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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