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GLP-1 / GIP Dual Agonist · Hot 2026

Tirzepatide API Supplier

CAS 2023788-19-2  ·  GLP-1 / GIP Dual Receptor Agonist  ·  Peptide API

GMP-certified Tirzepatide API sourced from audited manufacturers. USDMF available. Complete regulatory dossier delivered in 24 hours. The next-generation GLP-1/GIP molecule behind Mounjaro® / Zepbound®.

Purity≥98.5%HPLC
MOQ500 gR&D samples available
RegulatoryUSDMFAvailable
Response24 hrFull dossier
MechanismDualGLP-1 + GIP
Technical Specifications

Tirzepatide API — Full Technical Profile

INN / Generic NameTirzepatide
CAS Number2023788-19-2
Molecular FormulaC₂₂₅H₃₄₈N₄₈O₆₈
Molecular Weight4,813.4 g/mol
MechanismGLP-1 / GIP Dual Receptor Agonist (first-in-class)
Therapeutic UseType 2 Diabetes, Obesity (Mounjaro® / Zepbound® reference)
Purity (HPLC)≥98.5%
AppearanceWhite to off-white lyophilised powder
Storage−20°C (long-term); 2–8°C (short-term, up to 1 month)
Available GradesPharmaceutical / injectable grade; R&D grade
MOQ (commercial)500 g
MOQ (R&D)50 mg – 200 mg (subject to availability)
Lead Time6–10 weeks (standard); expedited options available
Country of OriginIndia / China (multi-source; confirmed at quote stage)
Molecule Comparison

Tirzepatide vs Semaglutide — Key Differences

Understanding the distinction helps buyers select the right API for their biosimilar or generic development programme.

ParameterTirzepatideSemaglutide
MechanismGLP-1 + GIP DualGLP-1 Mono
Weight loss (avg clinical)~21–22.5% bodyweight~15–17% bodyweight
Reference brandMounjaro® / Zepbound®Ozempic® / Wegovy®
MOQ (Generic Specialty)500 g1 kg
USDMF statusAvailableOn file / active
Peptide length39 amino acids31 amino acids (fatty acid conjugate)
Regulatory Documentation

Complete Source Quote — What's Included

Every Tirzepatide API inquiry from Generic Specialty returns a complete regulatory package. No follow-up emails, no waiting weeks for documents.

📋
Certificate of Analysis
Full CoA — assay, purity, impurities, residual solvents, water content, peptide content, microbial limits.
✓ Included
🇺🇸
USDMF Available
US Drug Master File available from manufacturing source. Reference letter provided for FDA ANDA/NDA submissions.
✓ Available
🧪
Impurity Profile
Full related substances characterisation per ICH Q3A — all process-related and degradation impurities identified.
✓ Included
📊
Stability Data
ICH Q1A stability study data at −20°C (long-term) and accelerated storage conditions.
✓ Included
🏭
GMP Certificate
Current GMP certificate from manufacturing site. USFDA, WHO-GMP, and/or EU GMP certifications available depending on source.
✓ Included
💰
Pricing & Lead Time
Indicative pricing, confirmed MOQ, and lead time from manufacturer — all in one response. No separate negotiations required.
✓ Included
Market Context 2026

Tirzepatide: The Fastest-Growing Peptide API

Tirzepatide's superior clinical efficacy data has driven Mounjaro® and Zepbound® to blockbuster status ahead of expectations. Biosimilar and generic developers are moving fast.

$25B+
Tirzepatide revenue forecast 2026
22%
Average weight loss (SURMOUNT)
30+
Active biosimilar programmes
2027+
Key biosimilar market entry
Complete Source Quote

Get Your Tirzepatide API Quote

Submit your requirements. We'll respond with a complete package — specs, pricing, regulatory docs — within 24 business hours.

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

✓ Response within 24 business hours  ·  [email protected]

Common Questions

Tirzepatide API — FAQ

Is Tirzepatide API available for biosimilar development?
Yes — Generic Specialty sources Tirzepatide API from GMP-certified manufacturers active in the biosimilar/generic development space. USDMF is available. We can support your pre-formulation, R&D, and commercial supply needs.
What is the difference between Tirzepatide and Semaglutide from a sourcing perspective?
Both are available through Generic Specialty. Tirzepatide is a GLP-1/GIP dual agonist (larger peptide, 39 amino acids) with a lower MOQ (500 g vs 1 kg for semaglutide). USDMF status differs — semaglutide has a USDMF on file/active, while tirzepatide USDMF is available. Both come with full regulatory dossiers.
What lead time should I expect for Tirzepatide API?
Standard commercial lead time is 6–10 weeks from confirmed purchase order. Expedited options may be available depending on batch availability. Lead time is confirmed in writing within 24 hours as part of the Complete Source Quote.
Does Generic Specialty manufacture Tirzepatide?
No — we are an independent API sourcing partner, not a manufacturer. We source Tirzepatide API from a curated network of GMP-audited peptide manufacturers, giving you access to multiple qualified sources and competitive pricing.