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Semaglutide

Short Description:

Semaglutide is a long-acting GLP-1 receptor agonist used for the treatment of type 2 diabetes and chronic weight management. Our high-purity Semaglutide API is produced through chemical synthesis, free from host cell proteins and DNA residues, ensuring excellent biosafety and consistent quality. Compliant with FDA guidelines, our product meets stringent impurity limits and supports large-scale production.


Product Detail

Product Tags

Semaglutide API 

Semaglutide is a synthetic long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, developed for the treatment of type 2 diabetes mellitus and obesity. Structurally modified to resist enzymatic degradation and enhance half-life, Semaglutide allows for convenient once-weekly dosing, significantly improving patient adherence.

Our Semaglutide API is produced via a fully synthetic process, eliminating risks associated with biological expression systems, such as host cell protein or DNA contamination. The entire manufacturing process has been developed and validated at kilogram scale, meeting the stringent quality requirements outlined in the FDA’s 2021 guidance on ANDA submissions for high-purity synthetic peptide drugs.

Mechanism of Action

Semaglutide mimics human GLP-1, an incretin hormone that plays a critical role in glucose metabolism. It acts through several synergistic mechanisms:

  • Stimulates insulin secretion in a glucose-dependent manner

  • Suppresses glucagon secretion, reducing hepatic glucose output

  • Delays gastric emptying, leading to improved postprandial glycemic control

  • Reduces appetite and energy intake, supporting weight loss

Clinical Outcomes

Extensive clinical studies (e.g., the SUSTAIN and STEP trials) have demonstrated that Semaglutide:

  • Significantly lowers HbA1c and fasting plasma glucose levels in type 2 diabetes patients

  • Promotes substantial and sustained weight loss in overweight or obese individuals

  • Reduces cardiovascular risk markers such as blood pressure and inflammation

With a favorable safety profile and broad metabolic benefits, Semaglutide has become a first-line GLP-1 RA in diabetes and anti-obesity therapy. Our API version maintains high structural fidelity and low impurity levels (≤0.1% unknown impurities by HPLC), ensuring excellent pharmacological consistency.


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