How to Source Isradipine for Pharmaceutical Formulation
Isradipine (Capsules, 2.5mg, 5mg) is classified under Hypertension. It is therapeutically aligned with reference brands such as DynaCirc (USA),. This guide highlights key sourcing factors buyers should consider when procuring high-quality Isradipine for formulation, R&D, or bulk manufacturing.
Product Overview:
Isradipine is a dihydropyridine calcium-channel blocker used for treating high blood pressure. It relaxes blood vessels, allowing smoother blood flow and reducing cardiovascular load. Although early branded versions like DynaCirc were discontinued, the molecule remains available as a generic in many regions.
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
Isradipine 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 Isradipine 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 Isradipine is more than procurement—it’s a strategic partnership. With its capsules form and 2.5mg, 5mg 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 Isradipine.
Frequently Asked Questions For Sourcing of Isradipine
What is the typical lead time for Isradipine?
Lead times range from 4–6 weeks depending on supplier and region.
Is Isradipine available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Isradipine require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Isradipine?
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 Isradipine?
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 Isradipine?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Isradipine suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Isradipine 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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