We submit your drug products manufactured under approved monographs to FDA for registration and NDC number assignment.
We provide high-quality drug products to support your pursuit of regulatory approval, offering fit-for-purpose formulations for studies and a comprehensive range of finished forms. Our robust solutions include:
- cGMP manufacturing at all scales
- Topical solutions with sustained bioavailability
- Quality design and product development
- Analytical and stability testing on finished products
- Registration batches, documentation for regulatory submissions