How to Source Sitagliptin + Metformin XR Tablets for Pharmaceutical Formulation

Sitagliptin + Metformin XR Tablets (Tablets, 100/1000 mg) is classified under Diabetes. It is therapeutically aligned with reference brands such as Janumet XR (US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Sitagliptin + Metformin XR Tablets for formulation, R&D, or bulk manufacturing.

Product Overview: Sitagliptin inhibits DPP-4, prolonging incretin activity to enhance insulin secretion and suppress glucagon release. Metformin decreases hepatic glucose production and improves insulin sensitivity. The XR formulation ensures steady glucose control with reduced gastrointestinal side effects. Together, they offer synergistic action, improved glycemic control, and convenient once-daily dosing for Type 2 diabetes management.

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

Sitagliptin + Metformin XR 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 Sitagliptin + Metformin XR 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 Sitagliptin + Metformin XR Tablets is more than procurement—it’s a strategic partnership. With its tablets form and 100/1000 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 Sitagliptin + Metformin XR Tablets