How to Source Lercanidipine for Pharmaceutical Formulation
Lercanidipine (Tablets, 10mg, 20mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Zanidip (EU/UK), Lercadip (EU/UK). This guide highlights key sourcing factors buyers should consider when procuring high-quality Lercanidipine for formulation, R&D, or bulk manufacturing.
Product Overview:
Lercanidipine is a calcium channel blocker (dihydropyridine class) used primarily for the treatment of hypertension (high blood pressure). It works by relaxing and widening blood vessels, allowing blood to flow more easily and reducing the workload on the heart.
Lercanidipine helps prevent complications associated with high blood pressure such as heart attacks, strokes, and kidney damage. It has a long duration of action and is typically administered once daily.
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
Lercanidipine 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 Lercanidipine 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 Lercanidipine is more than procurement—it’s a strategic partnership. With its tablets form and 10mg, 20mg 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 Lercanidipine.
Frequently Asked Questions For Sourcing of Lercanidipine
What is the typical lead time for Lercanidipine?
Lead times range from 4–6 weeks depending on supplier and region.
Is Lercanidipine available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Lercanidipine require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Lercanidipine?
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 Lercanidipine?
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 Lercanidipine?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Lercanidipine suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Lercanidipine 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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