API Development and Manufacturing Product Inquiry
Exclusively Manufactured in the USA
- Qualified State-of-the-art equipment & facilities
- Quality Highest Purity Drug Ingredients
- Value Consistent, respected, reliable
- Validated FDA registered and inspected
- Trusted Most stringent quality system
- Support DMF submission
- Security Made in the USA
API Focus & Expertise
- Small Volume Support
- Small Molecule Synthesis
- Orphan Drug Substance Quantities
- Chlorinations / Chloride Compounds
- Salts of Complex Organic Compounds
- Inorganic & Boutique Organic Synthesis
- Full Compliance vs. Atypical Standards
- Low Bioburden, Low Endotoxin Demands
- Parenteral / Oral / Transdermal Applications
API Support Package
Process Development – Manufacture of Registration Batches – Ongoing Support
Analytical Support
- Analytical Method Validation
- Transfer of Analytical Methods
- Custom Analytical Methods and Specifications
- Bioburden and Endotoxin Testing
- Complete Impurity Profile
- Elemental Impurities
- Residual Solvents
Development Support
- Stability Study
- Custom GMP Services as needed
- Custom Labeling and Packaging
- Manufacture of API Registration Batches
- Drug Master File submission
- Letter of Authorization
- Efficient Development Timeline
- High-touch management of your project
Ongoing Support - Post FDA Approval
- Commercial Manufacturing of your API
- On Site Audits
- Annual Product Review
- Management of Change
- Post Submission Change Notification
- Full support through the life of your product