How to Source Clarithromycin ER tablets for Pharmaceutical Formulation
Clarithromycin ER tablets (Extended-Release Tablets, 500 mg) is classified under Antibiotics. It is therapeutically aligned with reference brands such as Biaxin (EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Clarithromycin ER tablets for formulation, R&D, or bulk manufacturing.
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
Clarithromycin ER tablets 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 Clarithromycin ER tablets 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 Clarithromycin ER tablets is more than procurement—it’s a strategic partnership. With its extended-release tablets form and 500 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 About Clarithromycin ER tablets
What is the typical lead time for Clarithromycin ER tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Clarithromycin ER tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Clarithromycin ER tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.