Highlights of Our Manufacturers

The manufacturers we partner with offer a full range of capabilities from kilo lab-scale production up to and including the largest bulk Active Pharmaceutical Ingredient (API) manufacturer in China and they have with DMF/VMFs ready and approved materials.

Many offer a full range of regulatory, validation, auditing and compliance services needed to prepare various submissions in the U.S. Europe and Australia including:

• FDA, EDQM, and TGA approvals
• GMP for API and GMP compliance for final products
• ISO14001 Environmental Management System certification
• Parenteral drug formulation R&D lab with GLP standard
• GLP Analytical R&D lab
• GLP QC lab
• Good QA and EHS system