Great news! The raw material drug of Modif Semaglutide has been successfully registered with the FDA!
Public date：2025-06-16 10:06
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Recently, the semaglutide bulk drug substance developed by SUZHOU MOTIF BIOTECH CO., LTD. (hereinafter referred to as MOTIF BIOTECH) has successfully completed the registration of the Drug Master File (DMF) with the US Food and Drug Administration (FDA) (filing number: 041860). This marks a new breakthrough for the company in the research and development of GLP-1 peptide bulk drug substances.
The completion of this DMF registration indicates that Modif Bio has met the requirements of international standards in aspects such as process development, quality control, and large-scale production of semaglutide bulk drug substances.
The Suzhou headquarters of Motif occupies an area of 4,300 square meters and has multiple polypeptide drug R & D and production workshops. The total number of laboratories exceeds 100, including synthesis, purification and analysis laboratories, which can meet customers' needs for different polypeptide - related projects. The company has a complete quality management system. The GMP workshops are designed and constructed in strict accordance with the guidelines of ICHQ7. The production and quality of polypeptide drugs are carried out in accordance with the compliance requirements of FDA, EMA and NMPA.
The Motif technology service platform covers a professional, customized and integrated service platform for polypeptide drugs from early drug discovery, pre - clinical research to the production of clinical trial samples. We use solid - phase, liquid - phase and solid/liquid - phase synthesis methods to provide bioactive polypeptides of different varieties, scales and uses. The company is committed to improving the R&D efficiency of polypeptide drugs for global partners, reducing the R & D threshold, and helping to accelerate the development process of polypeptide innovative drugs and generic drugs to meet the needs of partners at all stages.
Tip: Tips on Semaglutide
Semaglutide is a GLP-1 receptor agonist. With its excellent blood sugar-lowering, weight loss, and cardiovascular protective effects, it has become a "star drug" in the global diabetes and obesity treatment fields. The approved indications this time include:
✅ Type 2 diabetes (to assist in controlling blood sugar through diet and exercise)
✅ Obesity or overweight (BMI ≥ 27kg/m² with complications)
Core Advantages:
Long - term blood sugar control: Administer the drug once a week, significantly improving patient compliance.
Multiple benefits: Remarkable weight - loss effect while reducing cardiovascular risks.
High safety: Verified by over one million patients globally, with controllable adverse reactions.