How to Source Ezetimibe + Atorvastatin for Pharmaceutical Formulation
Ezetimibe + Atorvastatin (Tablets, 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Liptruzet (USA), Atozet (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ezetimibe + Atorvastatin for formulation, R&D, or bulk manufacturing.
Product Overview:
Ezetimibe/Atorvastatin is a combination medication used to lower cholesterol levels in patients with hyperlipidemia. It works by reducing the absorption of cholesterol in the intestine (Ezetimibe) and inhibiting cholesterol synthesis in the liver (Atorvastatin). This dual action helps decrease LDL cholesterol and triglycerides while increasing HDL cholesterol.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Ezetimibe + Atorvastatin must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Ezetimibe + Atorvastatin is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Ezetimibe + Atorvastatin is more than procurement—it’s a strategic partnership. With its tablets form and 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Ezetimibe + Atorvastatin.
Frequently Asked Questions For Sourcing of Ezetimibe + Atorvastatin
What is the typical lead time for Ezetimibe + Atorvastatin?
Lead times range from 4–6 weeks depending on supplier and region.
Is Ezetimibe + Atorvastatin available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Ezetimibe + Atorvastatin require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Ezetimibe + Atorvastatin?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Ezetimibe + Atorvastatin?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Ezetimibe + Atorvastatin?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Ezetimibe + Atorvastatin suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Ezetimibe + Atorvastatin be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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