Tirzepatide API
Tirzepatide is a dual GIP/GLP-1 receptor agonist with rapidly growing global demand in diabetes and obesity treatment markets.
For generic pharmaceutical companies and CDMOs, selecting a high-quality, regulatory-ready API supplier is essential to ensure successful development and approval.
We provide high-purity Tirzepatide API with controlled impurity profile, supported by a DMF under preparation, designed to meet FDA and EMA expectations and minimize CMC risks.
Built for partners seeking speed, compliance, and reliability
Trust & Regulatory Positioning
DMF Status (US): Under preparation (FDA-aligned structure)
LOA Support: Available upon DMF activation
EMA Support: Full Module 3 (CMC) documentation
ICH Compliance: Q7 / Q11 / Q3A / Q3C / Q3D aligned
Audit Support: Customer audits supported (remote / on-site),Suitable for early-stage collaboration and pipeline planning
Product Specifications
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Purity | ≥99% (HPLC) |
| Molecular Weight | ~4813 Da |
| Manufacturing Method | SPPS |
| Storage | -20°C |
| Retest Period | 24 months |
Quality Advantage (Key Differentiator)
High purity (≥99% HPLC)
Well-controlled impurity profile
Low process-related impurities
Excellent batch-to-batch consistency
Benefits for customers:
Reduced regulatory risk
Easier method validation
Improved stability predictability
CMC & Technical Strength Analytical Capabilities
Advanced solid-phase peptide synthesis (SPPS) technology
Controlled critical quality attributes (CQA)
Scalable process for commercial production
HPLC (assay & impurities)
LC-MS / HRMS
Peptide mapping
Amino acid analysis
Residual solvents
(ICH Q3C)Elemental impurities (ICH Q3D)
Manufacturing Strength
We operate a robust manufacturing infrastructure:
Total site area: ~55 mu (~36,700 m²)
Total built-up area: ~70,000 m²
R&D Center: ~800 m²
QC Center: ~1,000 m²
GMP Workshops: ~3,300 m²
13 production lines7 peptide API lines (recombinant & synthetic)
6 sterile injectable lines Ensuring reliable scale-up and long-term supply capability
Documentation Package (Filing-Oriented)
DMF (in preparation)Certificate of Analysis (COA)
Impurity Profile
ReportStability
Data Method
ValidationResidual
Solvent Report
Elemental Impurity ReportProcess
Description Documentation customizable for US / EU / ROW
Development & Supply Support
Suitable for generic and innovative pipeline projects
Clinical to commercial supply support
Flexible scale (mg → kg)
Stable supply chain
