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Cardiovascular

Atorvastatin Calcium API Supplier

CAS 134523-03-8  ·  Cardiovascular · HMG-CoA Reductase Inhibitor · Statin

GMP-certified Atorvastatin Calcium API — the world's highest-selling statin. USDMF, CEP, and JDMF all on file. Complete regulatory package for global generic programmes.

Request Complete Source Quote View Specifications
Purity≥99.0%HPLC
MOQ50 kgStandard commercial
RegulatoryUSDMFTriple filing
Response24 hrFull dossier
OriginMultiIndia
Technical Specifications

Atorvastatin Calcium API — Full Technical Profile

INN / Generic NameAtorvastatin Calcium
CAS Number134523-03-8
Molecular FormulaC₆₆H₆₈CaF₂N₄O₁₀
Molecular Weight1,209.4 g/mol (calcium salt)
Mechanism / ClassHMG-CoA reductase inhibitor — reduces LDL cholesterol synthesis
Therapeutic UseHypercholesterolaemia, cardiovascular risk reduction (Lipitor® reference)
Purity (HPLC)≥99.0%
AppearanceWhite to off-white crystalline powder
StorageStore below 30°C; protect from moisture
MOQ (commercial)50 kg
MOQ (R&D)100 g – 1 kg
Lead Time3–6 weeks
Regulatory FilingsUSDMF + CEP + JDMF
Country of OriginIndia
Regulatory Documentation

Complete Source Quote — What's Included

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

📋
Certificate of Analysis
Full CoA — assay, related substances, water content, heavy metals, residual solvents, polymorphic form.
✓ Included
🇺🇸
USDMF on File
US Drug Master File active. Supports FDA ANDA filings for generic Atorvastatin.
✓ On File / Active
🇪🇺
CEP Certified
Certificate of Suitability (Ph.Eur.) issued for EMA submissions.
✓ CEP Issued
🇯🇵
JDMF Available
Japan Drug Master File available. Supports PMDA submissions.
✓ On File
🧪
Impurity Profile
Full ICH Q3A characterisation — all known statin-related impurities profiled and qualified.
✓ Included
📊
Stability Data
ICH Q1A stability data for both crystalline Form I and amorphous forms.
✓ Included
Market Context

Atorvastatin Calcium — Key Figures

$1.5B+
Global generic market
3
Major regulatory filings
50 kg
Commercial MOQ
3–6 wk
Lead time
Complete Source Quote

Get Your Atorvastatin Calcium API Quote

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

  • Certificate of Analysis (CoA)
  • USDMF + CEP + JDMF — 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
Atorvastatin Calcium API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Atorvastatin Calcium API — FAQ

Which polymorph of Atorvastatin Calcium do you supply?
We supply both Form I (crystalline) and amorphous Atorvastatin Calcium. Polymorph specification is confirmed at the quote stage based on your formulation requirements. Full polymorphic characterisation (XRPD, DSC) is included in the CoA.
Do you have USDMF, CEP, and JDMF all on file?
Yes — Atorvastatin Calcium is one of our most comprehensively filed molecules with USDMF (FDA), CEP (EMA/EDQM), and JDMF (PMDA Japan) all on file. This makes it ideal for global simultaneous generic submissions.
What are the nitrosamine testing requirements for Atorvastatin?
Atorvastatin Calcium does not fall under the high-risk nitrosamine categories (unlike sartans or metformin), but our manufacturers follow current FDA/EMA nitrosamine guidance with routine risk assessment documentation provided in the dossier.
Does Generic Specialty Group manufacture Atorvastatin Calcium?
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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