Semaglutide API
Executive Summary
For generic pharmaceutical companies and CDMOs, the key to a successful Semaglutide project lies in regulatory readiness, impurity control, and supplier reliability.
We offer high-purity Semaglutide API with a well-controlled impurity profile, supported by a DMF currently under preparation, designed to meet FDA and EMA expectations and reduce CMC-related risks during review.
Built for partners who prioritize faster approval, lower risk, and consistent quality
Trust & Regulatory Positioning
DMF Status (US):
Under preparation (structure aligned with FDA requirements)
LOA Support:
Available upon DMF activation
EMA Submission Support:
Full Module 3 (CMC) documentation
ICH Compliance:
Q7 / Q11 / Q3A / Q3C / Q3D aligned
Audit Support:
Open to customer audits (remote / on-site)
Early collaboration supported for customers planning
pipeline development and filing strategy
Quality Advantage
Compared to typical market supply, our Semaglutide demonstrates:
Higher purity consistency (≥99% HPLC)
Tighter impurity control
(process-related & degradation impurities)
Cleaner impurity profile for easier regulatory acceptance
Improved batch-to-batch reproducibility
This directly reduces:
Regulatory query risk
Method validation burden
Stability uncertainty
CMC & Technical Strength
Optimized SPPS (Solid-Phase Peptide Synthesis) process
Defined and controlled Critical Quality Attributes (CQA)
Scalable manufacturing from R&D to commercial level
Analytical Capabilities
HPLC (assay & related substances)
LC-MS / HRMS
Peptide mapping
Amino acid analysis
Residual solvents (ICH Q3C)
Elemental impurities (ICH Q3D)
Product Specifications
Item Specification
Appearance White to off-white powder
Purity ≥99% (HPLC)
Molecular Weight ~4113.6 Da
Manufacturing Method SPPS
Storage -20°C
Retest Period 24 months
Development & Supply Support Why Clients Move Forward With Us
Suitable for generic drug development & CDMO projects
Support from early-stage development to commercial supply
Flexible scale (mg → kg)
Stable and scalable production capacity
Clear regulatory pathway (DMF in progress)
Demonstrated quality advantage (purity & impurity control)
Reduced CMC risk during review
Responsive technical & regulatory communication
A practical partner for companies that need both compliance and speed
Documentation Package (Filing-Oriented)
We provide a regulatory-focused documentation package:
DMF (in preparation, available upon completion)
Certificate of Analysis (COA)
Impurity Profile Report
Stability Data (accelerated & long-term)
Analytical Method Validation
Residual Solvent Report
Elemental Impurity Report
Process Description
Documentation can be customized for US / EU / ROW submissions