U.S. FDA Registrations and Compliance
503B Outsourcing Facility (MOS)
MOS functions as a registered FDA 503B Outsourcing Facility, providing pharmacist-directed oversight of sterile drug manufacturing. Operations follow:
- FDA 503B guidance
- cGMP requirements
- USP sterile compounding and quality standards
The Quality Unit (QA, QC, QEV) maintains full authority over batch review, product release, and ongoing compliance.
NDA Ownership – Ascor® (MPI)MPI holds the New Drug Application (NDA) for Ascor®, establishing the company as the official regulatory owner and manufacturer. Key regulatory designations include:
- Reference Listed Drug (RLD) status
- Orphan Drug designation, providing market exclusivity and FDA-recognized benefits
- FDA-approved labeling, CMC data, and stability programs supporting the NDA
This level of regulatory responsibility demonstrates MPI's ability to manage full-life-cycle drug oversight.
ANDA Development ExpertiseMPI has developed the ANDA for Hydroxyprogesterone Injection, supported by validated manufacturing processes, analytical methods, and cGMP documentation. Experience includes:
- CMC module development
- Stability study design
- Process validation
- Regulatory submission formatting and support
