How to Source Gemfibrozil tablet/ Capsule for Pharmaceutical Formulation

Gemfibrozil tablet/ Capsule (Tablet/Capsules, 600 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Lopid(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Gemfibrozil tablet/ Capsule for formulation, R&D, or bulk manufacturing.

Product Overview: Gemfibrozil is a fibrate that activates PPARα receptors, improving lipid metabolism. It significantly lowers triglycerides, increases HDL cholesterol, and modestly reduces LDL cholesterol. Benefits include reducing cardiovascular risk, preventing pancreatitis, and supporting long-term management of dyslipidemia, promoting overall heart health and metabolic balance. Gemfibrozil tablets and capsules, marketed as Lopid, are approved in the US by the FDA and in the EU...

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

Gemfibrozil tablet/ Capsule 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 Gemfibrozil tablet/ Capsule 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 Gemfibrozil tablet/ Capsule is more than procurement—it’s a strategic partnership. With its tablet/capsules form and 600 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 Gemfibrozil tablet/ Capsule