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

Product Inquiry