How to Source Alogliptin+Metformin for Pharmaceutical Formulation
Alogliptin+Metformin (Tablets, 12.5mg+500mg / 12.5mg+850mg / 12.5mg+1000mg) is classified under Diabetes. It is therapeutically aligned with reference brands such as Kazano (USA), Vipdomet (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Alogliptin+Metformin 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
Alogliptin+Metformin 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 Alogliptin+Metformin 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 Alogliptin+Metformin is more than procurement—it’s a strategic partnership. With its tablets form and 12.5mg+500mg / 12.5mg+850mg / 12.5mg+1000mg 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 Alogliptin+Metformin
What is the typical lead time for Alogliptin+Metformin?
Lead times range from 4–6 weeks depending on supplier and region.
Is Alogliptin+Metformin available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Alogliptin+Metformin require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Alogliptin+Metformin?
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 Alogliptin+Metformin?
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 Alogliptin+Metformin?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Alogliptin+Metformin suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Alogliptin+Metformin be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.