How to Source Montelukast Sodium tablets for Pharmaceutical Formulation
Montelukast Sodium tablets (Tablets, Chewable Tablets, Oral Granules, Tablets:10 mg; Chewable Tablets: 4 mg / 5 mg; Oral Granules:4 mg (sachet)) is classified under Allergy Medication. It is therapeutically aligned with reference brands such as Singulair®, Montelukast Teva(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Montelukast Sodium 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
Montelukast Sodium 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 Montelukast Sodium 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 Montelukast Sodium tablets is more than procurement—it’s a strategic partnership. With its tablets, chewable tablets, oral granules form and Tablets:10 mg; Chewable Tablets: 4 mg / 5 mg; Oral Granules:4 mg (sachet) 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 Montelukast Sodium tablets
What is the typical lead time for Montelukast Sodium tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Montelukast Sodium tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Montelukast Sodium tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.