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

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