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GLP-1 / Cardiovascular

Liraglutide API Supplier

CAS 204656-20-2  ·  GLP-1 Receptor Agonist · Peptide API

GMP-certified Liraglutide API — the original GLP-1 receptor agonist behind Victoza® and Saxenda®. CEP and USDMF both on file. Complete regulatory dossier in 24 hours.

Purity≥98.0%HPLC
MOQ2 kgR&D samples available
RegulatoryCEPBoth on file
Response24 hrFull dossier
OriginMultiIndia / China
Technical Specifications

Liraglutide API — Full Technical Profile

INN / Generic NameLiraglutide
CAS Number204656-20-2
Molecular FormulaC₁₇₂H₂₆₅N₄₃O₅₁
Molecular Weight3,751.2 g/mol
Mechanism / ClassGLP-1 Receptor Agonist (once-daily)
Therapeutic UseType 2 Diabetes, Chronic Weight Management (Victoza® / Saxenda® reference)
Purity (HPLC)≥98.0%
AppearanceWhite to off-white lyophilised powder
Storage2–8°C (short-term); −20°C (long-term)
MOQ (commercial)2 kg
MOQ (R&D)200 mg – 1 g
Lead Time4–8 weeks
Regulatory FilingsCEP + USDMF
Country of OriginIndia / China
Regulatory Documentation

Complete Source Quote — What's Included

Every Liraglutide API inquiry returns a complete regulatory package in 24 hours.

📋
Certificate of Analysis
Full CoA — assay, purity, impurity profile, residual solvents, peptide content, microbial limits.
✓ Included
🇺🇸
USDMF on File
US Drug Master File active. Reference letter for FDA ANDA/NDA submissions provided on request.
✓ On File / Active
🇪🇺
CEP Certified
Certificate of Suitability (Ph.Eur.) issued. Supports European marketing authorisation applications.
✓ CEP Issued
🧪
Impurity Profile
Full characterisation per ICH Q3A — all related substances identified, qualified, and quantified.
✓ Included
📊
Stability Data
ICH Q1A-compliant stability data at 2–8°C and accelerated conditions.
✓ Included
🏭
GMP Certificate
Current GMP certificate from manufacturing site. WHO-GMP and USFDA-inspected facilities available.
✓ Included
Market Context

Liraglutide — Key Figures

$15B+
Global GLP-1 market (legacy)
20+ yr
Clinical track record
2
Major approved indications
Global
Multi-market dossiers
Complete Source Quote

Get Your Liraglutide API Quote

Submit your requirements. We'll respond with a complete package within 24 business hours.

  • Certificate of Analysis (CoA)
  • CEP + USDMF — reference letter / status
  • Full impurity profile per ICH Q3A
  • Stability data summary
  • GMP certificate + site details
  • Pricing, MOQ, and lead time
  • Country of origin confirmation
Liraglutide API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Liraglutide API — FAQ

What is the difference between Liraglutide and Semaglutide?
Liraglutide is a once-daily GLP-1 receptor agonist (shorter half-life), while Semaglutide is once-weekly (longer half-life via fatty acid conjugation). Liraglutide has a longer established clinical record. Both are available through Generic Specialty with complete regulatory dossiers.
Is CEP documentation available for Liraglutide?
Yes — Liraglutide API from our source has a valid CEP (Certificate of Suitability to the Ph.Eur. monograph), making it directly suitable for EMA marketing authorisation applications without separate European regulatory assessment.
What markets can you support for Liraglutide supply?
We support FDA (USA), EMA (EU), Health Canada, TGA (Australia), PMDA (Japan), and multiple emerging markets. CEP + USDMF combination provides excellent multi-market coverage.
Does Generic Specialty Group manufacture Liraglutide?
No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.
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