Regulatory Roadmap for Peptide APIs | GMP & DMF Compliance

Regulatory & Compliance

CMC Compilation

Relevant Chemistry, Manufacturing and Controls (CMC) documents have been compiled and organized to ensure data accuracy and completeness, laying a solid foundation for product registration and market access.

DMF Compilation and Submission

The Drug Master Files (DMFs) for Utide’s peptide APIs, Tirzepatide and Retatrutide, have been accepted by the U.S. FDA and are officially listed in the FDA DMF database (DMF Nos. 042984 and 043330, respectively), demonstrating our compliance with international regulatory standards.

Annual Product Reviews

Conduct annual product reviews regularly to analyze product quality, compliance, and market feedback, adjust strategies promptly, and ensure sustained alignment with regulatory requirements and market demands.

On-schedule Development of New GMP facility

The development of our new GMP manufacturing facility is progressing on schedule as a key strategic initiative.

GMP Facility Development Roadmap (Planned)

Q4 2025

Preparation Phase

1. Finalisation of the GMP manufacturing site location, with a planned facility area of approximately 100000 m².
2. Completion of the facility design in compliance with USP, EP, and GMP requirements, including clearly defined areas for synthesis, purification, lyophilisation, and QC laboratories.
3. Tendering and appointment of an EPC general contractor with proven qualifications and experience in pharmaceutical GMP facility construction.

Q1 2026 – Q3 2026

Construction Phase

1. Q1 2026: Completion of the main facility construction, including walls, flooring, and ceilings, using GMP-compliant cleanroom materials.
2. Q2 2026: Installation and commissioning of key manufacturing equipment, including:
– 1000 L peptide synthesis systems ×3
– DAC-800 chromatography systems ×2
– Lyophilisation units ×2
3. Q3 2026: Execution of equipment qualification activities:
1. Installation Qualification (IQ): Verification that equipment installation meets design specifications and that all supporting utilities (power supply, piping, etc.) are properly installed.
2. Operational Qualification (OQ): Verification of critical operating parameters, such as temperature control accuracy of synthesis systems and pressure stability of chromatography systems.
3. Performance Qualification (PQ): Demonstration of consistent and stable equipment performance through simulated production batches.

Q4 2026 – Q2 2027

System Commissioning & Production Line Start-up Ph

1. Q4 2026: Completion of validation for HVAC, purified water, and compressed air systems, achieving Class 8 cleanroom standards. 2. Q1 2027: Completion of process commissioning, including three pilot-scale Semaglutide batches to verify production line robustness, along with cleaning validation. 3. Q2 2027: Official start-up of the production line, limited to R&D and pilot-scale manufacturing.

Q3 2027 – Q1 2028

GMP System Establishment & Certification Phase

1. Q3 2027 : Establishment of a comprehensive GMP quality management system, covering documentation control, personnel training, deviation management, and related quality processes, while accumulating data through multiple pilot-scale batches. 2. Q4 2027: Preparation and submission of GMP certification application materials to the NMPA, including equipment qualification records, process documentation, and quality data. 3. Q1 2028: Support and completion of on-site GMP inspection, with the planned achievement of GMP certification.

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