FDA Approval Track Record

Demonstrated Experience. Proven Results.

PD Partners has an established track record of successfully developing pharmaceutical formulations and preparing and submitting Abbreviated New Drug Applications (ANDAs) that have received FDA approval. Our experience encompasses the complete development and regulatory submission process, providing clients with the scientific expertise, regulatory knowledge, and practical experience necessary to advance pharmaceutical products toward commercialization.

The products highlighted below represent successful FDA approvals resulting from development and regulatory submission work performed by PD Partners. While most applications were submitted on behalf of our clients and approved under their respective companies, others are held directly by PD Partners. The majority of these approved products are currently marketed, demonstrating our experience in bringing pharmaceutical products from initial development through regulatory approval and into commercial distribution.

FDA Approved Products

 

Chart showing 13 FDA-approved pharmaceutical products developed by PD Partners, including brivaracetam, ibuprofen, potassium chloride, sucralfate, levetiracetam, lacosamide, and other oral pharmaceutical formulations, with estimated market sizes.