How to Source Dronedarone hydrochloride for Pharmaceutical Formulation
Dronedarone hydrochloride (Tablets, 400 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Multaq (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Dronedarone hydrochloride for formulation, R&D, or bulk manufacturing.
Product Overview:
Dronedarone hydrochloride is a class III antiarrhythmic medication used to maintain normal heart rhythm in adults with a history of atrial fibrillation or atrial flutter. It helps reduce the risk of hospitalization due to these rhythm disorders. The drug is given orally as a 400 mg tablet taken twice daily with food. It works by blocking multiple cardiac ion channels to stabilize electrical activity in the heart. Dronedarone is an alternative to amiodarone with a modified chemical structure aimed at reducing certain toxicities.
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
Dronedarone hydrochloride 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 Dronedarone hydrochloride 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 Dronedarone hydrochloride is more than procurement—it’s a strategic partnership. With its tablets form and 400 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 Dronedarone hydrochloride.
Frequently Asked Questions For Sourcing of Dronedarone hydrochloride
What is the typical lead time for Dronedarone hydrochloride?
Lead times range from 4–6 weeks depending on supplier and region.
Is Dronedarone hydrochloride available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Dronedarone hydrochloride require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Dronedarone hydrochloride?
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 Dronedarone hydrochloride?
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 Dronedarone hydrochloride?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Dronedarone hydrochloride suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Dronedarone hydrochloride 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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