How to Source Diltiazem tablets/capsules for Pharmaceutical Formulation
Diltiazem tablets/capsules (Tablet/Capsules, IR: 0 mg, 60 mg, 90 mg, 120 mg; SR: Up to 540 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Cardizem(US); Dilzem(EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Diltiazem tablets/capsules for formulation, R&D, or bulk manufacturing.
Product Overview:
Diltiazem is a calcium channel blocker that relaxes blood vessels and reduces heart rate by inhibiting calcium entry into cardiac and vascular smooth muscle cells. It effectively treats hypertension, angina, and arrhythmias, providing benefits like lowered blood pressure, decreased chest pain, rhythm stabilization, and improved overall cardiovascular health.
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
Diltiazem tablets/capsules 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 Diltiazem tablets/capsules 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 Diltiazem tablets/capsules is more than procurement—it’s a strategic partnership. With its tablet/capsules form and IR: 0 mg, 60 mg, 90 mg, 120 mg; SR: Up to 540 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 Diltiazem tablets/capsules.
Frequently Asked Questions For Sourcing of Diltiazem tablets/capsules
What is the typical lead time for Diltiazem tablets/capsules?
Lead times range from 4–6 weeks depending on supplier and region.
Is Diltiazem tablets/capsules available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Diltiazem tablets/capsules require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Diltiazem tablets/capsules?
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 Diltiazem tablets/capsules?
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 Diltiazem tablets/capsules?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Diltiazem tablets/capsules suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Diltiazem tablets/capsules be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
Advertise on PharmaTradZ
Reach verified pharma buyers, suppliers & decision makers worldwide.
Explore Pharma Investment Opportunities
Connect with partners, startups & ventures driving the future of pharma.