Semaglutide

  • Advanced Fermentation Platforms
  • US DMF Certificate
  • GMP-Compliant Pharmaceutical Purity
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Semaglutide API

Semaglutide is the typical GLP-1 receptor agonist for the treatment of type 2 diabetes and obesity. It can regulate blood sugar levels, reduce appetite, and support weight management. Morebio provides high-quality Semaglutide that meets global pharmaceutical standards to ensure the safety, efficacy, and consistency of the Semaglutide API.

Semaglutide
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Semaglutide

  • Peptide Name: Semaglutide
  • CAS Number: 910463-68-2
  • Formula: C187H291N45O59
  • Molecular Weight: 4113.64g/mol
  • Sequence: HXEGT FTSDV SSYLE GQAAK EFIAW LVRGR G
  • Purity: 98%
  • Type: Drug Peptides, Synthetic peptide,
    GLP-1 receptor agonist
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Semaglutide Description

Our generic APIs are specialized in GLP-1 RAs and related intermediates. These generic APIs are utilized for the treatment of diabetes and obesity. Obesity and Type 2 Diabetes are widespread diseases with considerable levels of morbidity and mortality globally, primarily in the form of cardiovascular disease(CVD). Therefore, GLP-1 RAs are becoming the preferred treatment for obesity and T2DM. Moreover, clinical evidence demonstrates that these agents also have the potential benefit for cardiovascular and kidney diseases.

Semaglutide-2000

Semaglutide API Application

  • Formulation of diabetes management medications
  • Weight-loss therapies
  • Non-alcoholic fatty liver disease, neurological disorders
  • Pharmaceutical and research applications
Pharmacology Classification

Key Features&Benefits

  • Advanced bio-pharmaceutical facility for high quality
  • Stringent quality control to ensure API consistency
  • Expert support in technical and regulatory assistance
  • Efficient logistics for reliable distribution in worldwide
Clinical Application
US -FDA

DMF Certificate

Morebio achieves the FDA-DMF certificate for Semaglutide API (039115), Semaglutide Main Chain (039480).

Semaglutide API DMF-039115
Semaglutide API

DMF 039115

Semaglutide Main Chain DMF-039480
Semaglutide Main Chain

DMF 039480

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Genetic Synthesis of Semaglutide

Morebio applies new genetic technology for the synthesis of semaglutide API, our advanced technology generate semaglutide in fermentation of Escherichia coli(E. coli). Morebio has cutting-edge manufacturing facilities in industrial scales, this increase our production capability significantly. Our maximum batch size of semaglutide API can reach to 2.1 kg, and 200 kg in total per year. Even in pilot scale, we also have production capability of 30g.

The purity of semaglutide API in Morebio can reach more than 98%, our advanced manufacturing technology controls the impurities less than 2%. Comparing to Novo Nordisk, our simaglutide API has lower impurity.

SMLT Impurity Comparison

In addition, in reason of our unique synthesis technology, Morebio semaglutide has more stability than the original semaglutide from Novo Nordisk.

SMLT Stability Comparison
our Quality

Quality Insurance

  • Morebio has the stringent control standards in manufacturing process
  • Available in bulk quantities for global demands
  • Adheres to US FDA, EMA, GMP guidelines

Mechanism

  • Effective oral dosage forms to improve oral absorption rate.
  • Long-acting injections to prolong the action time of peptide drugs.
Quality Control
Indication
Semaglutide Reference

Indication

Semaglutide is a peptide-base therapeutic, it belongs to the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class. Semaglutide can mimic the effect of GLP-1, its modification has longer duration of action in the body with less administered frequency than the natural GLP-1 hormone. This makes it suitable for once-weekly dosing, and improves the patient adherence to treatment.

GLP-1

Glucagon-like peptide-1 (GLP-1) is a hormone in regulation of sugar blood levels, it is produced in the intestines. GLP-1 can stimulate insulin secretion from the pancreas, reduce glucagon production, slow down the stomach emptying, promote fullness feeling. All these effects improve glycemic control collectively, and cab be particularly beneficial for type 2 diabetes.

Semaglutide Reference

Action Mode

Semaglutide affects the glucose control in several different mechanisms, including: increasing insulin secretion, slowing down gastric emptying, reducing postprandial glucagon and food intake. GLP-1 has the major impact in glucose management, and semaglutide has an analog structure and simulates all the activities of GLP-1.

The innovative section of semaglutide is the structural modifications of amino acid substitution, which can generate stability against dipeptidyl peptidase-4, which is an enzyme that degrades incretins like GLP-1.

Action Mode
Semaglutide-1000
Semaglutide Reference

Structure

Semaglutide has 94% sequence homology with human GLP-1, it is the most critical receptor agonist of GLP-1. On the basis of liraglutide, semaglutide replace Lys with Arg at 34 position, replace Ala with 2-aminoisobutyric acid (AIB) at 8 position, and conjugate Lys with 18 carbon fatty acid chain at 18 position. Its affinity for albumin is six times of liraglutide, the half-life in human body is 165 hours.

The structure of semaglutide has (lysine acylation) with a spacer and C-18 fatty di-acid at position 26, and permits the specific binding to plasma albumin. These characteristics extend the half-life of semaglutide, increase patient compliance.