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Semaglutide API Supplier

CAS 910463-68-2  ·  GLP-1 Receptor Agonist  ·  Peptide API

GMP-certified Semaglutide API from audited manufacturers. USDMF on file. Complete regulatory dossier — CoA, impurity profile, stability data — delivered in 24 hours.

Purity≥99.0%HPLC
MOQ1 kgR&D samples available
RegulatoryUSDMFOn file / active
Response24 hrFull dossier
OriginMultiIndia · China · EU
Technical Specifications

Semaglutide API — Full Technical Profile

INN / Generic NameSemaglutide
CAS Number910463-68-2
Molecular FormulaC₁₈₇H₂₉₁N₄₅O₅₉
Molecular Weight4,113.58 g/mol
MechanismGLP-1 Receptor Agonist (long-acting)
Therapeutic UseType 2 Diabetes, Obesity (Wegovy® / Ozempic® reference)
Purity (HPLC)≥99.0%
AppearanceWhite to off-white lyophilised powder
SolubilitySoluble in water (buffered pH 7.4)
Storage−20°C (long-term); 2–8°C (short-term)
Available GradesPharmaceutical / injectable grade; R&D / research grade
MOQ (commercial)1 kg
MOQ (R&D)100 mg – 500 mg (subject to availability)
Lead Time4–8 weeks (standard); expedited available
PackagingAmber glass vials or HDPE drums under inert atmosphere
Country of OriginIndia / China (multi-source; confirmed at quote stage)
Regulatory Documentation

What's Included in Every Inquiry

Every Complete Source Quote for Semaglutide API includes the full regulatory package — no follow-up emails required.

📋
Certificate of Analysis
Full CoA with all critical quality attributes — assay, purity, impurities, residual solvents, water content, and microbial limits.
✓ Included
🇺🇸
USDMF Reference Letter
US Drug Master File on file and active. Reference letter for FDA ANDA/NDA submissions provided on request.
✓ On File / Active
🇪🇺
CEP Status
Certificate of Suitability (Ph.Eur.) application in progress. Current EP compliance documentation available.
⏳ CEP In Progress
🧪
Impurity Profile
Full impurity characterisation per ICH Q3A — all related substances identified, qualified, and quantified.
✓ Included
📊
Stability Data
ICH Q1A-compliant stability study data — long-term (−20°C) and accelerated (5°C / ambient) conditions.
✓ Included
🏭
GMP Certificate
Current GMP certificate from manufacturing site. Site audit history available for qualified buyers upon NDA.
✓ Included
Market Context 2026

Why Semaglutide API Demand Is Surging

The GLP-1 market is experiencing the fastest API demand growth in pharmaceutical history. Securing a reliable, documented supply chain now is critical.

$100B+
GLP-1 market by 2030
140k+
Monthly semaglutide searches
40+
Global biosimilar developers
2026
Key regulatory milestone year

Patent expiry timelines vary by jurisdiction. Novo Nordisk's Ozempic® and Wegovy® face biosimilar competition in select markets. Manufacturers and CMOs are actively qualifying API sources now — well ahead of launch windows.

Complete Source Quote

Get Your Semaglutide API Quote

Tell us your requirements. We'll send a complete package — specs, pricing, regulatory docs — within 24 business hours.

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

✓ Response within 24 business hours  ·  [email protected]

Common Questions

Semaglutide API — FAQ

What is the USDMF status for Semaglutide from Generic Specialty?
Our Semaglutide API is sourced from GMP-certified manufacturers with a USDMF on file and active. A DMF reference letter for FDA ANDA or NDA submissions is provided on request as part of the regulatory dossier.
Is R&D / small-quantity Semaglutide available?
Yes — R&D samples from 100 mg to 500 mg may be available for qualified pharmaceutical buyers. Commercial MOQ begins at 1 kg. Please specify your requirements in the inquiry form and we'll confirm availability.
What markets can Generic Specialty support for Semaglutide supply?
We support API supply for FDA (USA), EMA / Health Canada, TGA (Australia), PMDA (Japan), and multiple emerging markets. We confirm the relevant USDMF, CEP, or national filing status at quote stage for each target market.
Does Generic Specialty manufacture Semaglutide?
No — Generic Specialty is an independent API sourcing partner, not a manufacturer. We source from a network of qualified, GMP-audited manufacturers globally. This means we are not limited to one production facility and can compare options for your specific regulatory and commercial needs.
What is the typical lead time for Semaglutide API?
Standard commercial lead time is 4–8 weeks from confirmed purchase order. Expedited options may be available. Lead time is confirmed in writing as part of the Complete Source Quote within 24 hours.