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.

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.

MPI 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

MPI supports global access to sterile drug products through an expanding portfolio of international registrations.

• Ascor® is registered in 5 countries. These registrations follow ICH guidelines and region-specific regulatory standards.

• 15 additional regulatory submissions are underway across multiple global regions
• Dossiers are prepared in CTD or ACTD formats depending on regional requirements

MPI provides complete regulatory packages including:

• CMC documentation
• Stability data
• Validation reports
• Manufacturing process descriptions
• Product quality and sterility assurance evidence

This expansion supports MPI's strategic growth into international sterile drug markets.

MPI and MOS maintain robust systems to ensure compliance with U.S. and global expectations.

• Full Chemistry, Manufacturing & Controls (CMC) capabilities
• Stability and validation protocol development
• Lifecycle management for NDAs, ANDAs, and 503B drug products
• Supplier qualification, risk assessment, and annual re-audits
• Product quality review, deviation investigations, and continuous improvement programs
• Independent corporate QA auditor (MCI) providing oversight and inspection readiness

• Controlled document management systems supporting 21 CFR Part 11 compliance
• Standardized audit trails, batch documentation, and change control
• Support for adverse event reporting, complaint handling, and global quality requirements