How to Source Amiodarone Hcl 100 mg Tablet for Pharmaceutical Formulation

Amiodarone Hcl 100 mg Tablet (Tablets, 100 mg, 200 mg, 400 mg) is classified under Critical Care. It is therapeutically aligned with reference brands such as Pacerone(US), Cordarone. This guide highlights key sourcing factors buyers should consider when procuring high-quality Amiodarone Hcl 100 mg Tablet for formulation, R&D, or bulk manufacturing.

Product Overview: Amiodarone is a key antiarrhythmic drug available in 100–400 mg tablets and 50 mg/mL IV vials. Used for serious ventricular arrhythmias, brands include Cordarone and Amiodarone Hameln. Commonly supplied to hospitals and ICUs, it is a staple in pharma B2B cardiac care procurement and institutional sourcing platforms. Amiodarone is a widely prescribed anti-arrhythmic medication primarily approved by the U.S. Food and...

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

Amiodarone Hcl 100 mg Tablet 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 Amiodarone Hcl 100 mg Tablet 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 Amiodarone Hcl 100 mg Tablet is more than procurement—it’s a strategic partnership. With its tablets form and 100 mg, 200 mg, 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.

Frequently Asked Questions For Sourcing of Amiodarone Hcl 100 mg Tablet