Tirzepatide FDA DMF 041036

Suzhou Mo t if Biotech Co., Ltd. was founded in 2021 in the Suzhou New District and is an innovative peptide CRDMO (Contract Research, Development, and Manufacturing Organization) biotechnology company. In March 2023, the company's headquarters peptide R&D and production base in Suzhou was officially completed and commenced operations. Its core business revolves around the custom R&D, large-scale production, and full-chain technical services for peptide-related products.

The total area of the R&D and production base at the Suzhou headquarters is 4,300 m², housing over 100 laboratories. Their functions cover the entire R&D process, including peptide synthesis, purification, and analytical testing. The GMP production workshop spans approximately 800 m², designed and constructed in strict accordance with ICH-Q7 guidelines. The Drug Manufacturing License number is: Su 20240016, with a planned total annual capacity of 30 kg.

The Phase I planning for the Anhui production base covers an area exceeding 50,000 m², and Phase II planning exceeds 130,000 m². The Phase I facility focuses on the large-scale commercial production of peptides, with a planned annual capacity of 1,000 kg. It is equipped to efficiently handle production orders from global clients for commercial-stage new peptide drugs and peptide intermediates with high-volume demands.

In January 2025, the company's self-developed and produced Tirzepatide Active Pharmaceutical Ingredient (API) was successfully filed in the FDA's Drug Master File (DMF) under file number 041036. In June of the same year, the company's self-developed and produced Semaglutide API was successfully filed in the FDA DMF under file number 041860.

As an enterprise with peptide product R&D technology as its core competitiveness, Motif  possesses diversified and high-complexity peptide synthesis and process development capabilities. It can efficiently complete R&D services such as the synthesis and process optimization of tumor antigen peptides, peptide conjugates, cyclic peptides, long linear peptides, and modified peptides (including PEGylation). We support the contract R&D and custom production of cosmetic peptides and pet peptide drugs, meeting the specialized demand for high-quality peptide products in niche markets. The company also provides custom synthesis of peptide fragments, synthetic intermediates, and impurity reference standards, undertaking custom service projects for peptide-related research from universities and research institutes, thereby providing key material support for fundamental research and technological breakthroughs.

The company has established a multi-level service system. In the pharmaceutical field, we offer full lifecycle services: providing integrated solutions for global pharmaceutical companies and research institutions, spanning from early-stage discovery and pharmaceutical research to commercial large-scale production for new peptide drugs, aiding in accelerating the R&D process. The company possesses a peptide new drug API pharmaceutical research platform, a peptide generic drug API development platform, a peptide new drug candidate compound structural modification preparation platform, and a peptide new drug/generic drug impurity reference standard preparation platform. These platforms enable us to serve various peptide drug-related development, production, and management projects, backed by extensive project experience. We utilize technical methods such as SPPS (Solid Phase Peptide Synthesis) / LPPS (Liquid Phase Peptide Synthesis) / combined solid-liquid phase synthesis to provide peptides of different varieties, scales, and purposes. Mainstream drug analysis equipment includes brands like Agilent and WATERS, ensuring quality assurance.

In the field of cosmetic peptide R&D and custom production, Motif  focuses on in-depth exploration of the active mechanisms of peptides, with a key emphasis on researching their principles of action in core functions such as cell regeneration activation and delaying skin aging processes, laying a scientific foundation for the development of efficacious products. The company is committed to breakthroughs in structural innovation, developing more targeted cosmetic peptide raw materials, and expanding into diverse efficacy areas such as whitening and brightening, oil control and acne treatment, sensitive skin barrier repair, and anti-hair loss/hair strengthening, providing customized solutions for the market.

In the field of custom services for peptide research projects, Motif  has established a complex, long-acting peptide modification and optimization service platform, offering efficient, flexible, high-quality, and low-cost peptide-related project solutions for global partners. We are capable of producing over 95% of the custom synthetic peptide types available on the market, providing better support for the custom synthesis of complex peptides.

"Innovation as the source, technology as the foundation" is Motif 's steadfast mission, and "achieving success for clients, employees, and the company" is its enduring values. We are dedicated to enhancing peptide R&D efficiency, lowering R&D barriers, and helping accelerate the peptide product R&D process for global partners. In the future, Motif  will extend its industry chain based on its peptide CRDMO foundation, actively explore peptide-related technology licensing platforms and R&D platforms, aiming to become a benchmark enterprise for global, all-category peptide CRDMO business.