How to Source Imipenem + Cilastatin Powder for Reconstitution for Pharmaceutical Formulation

Imipenem + Cilastatin Powder for Reconstitution (Powder for Reconstitution, 500 mg/500 mg, 1 g/1 g in vials) is classified under Antibiotics. It is therapeutically aligned with reference brands such as Primaxin, Gemax (US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Imipenem + Cilastatin Powder for Reconstitution for formulation, R&D, or bulk manufacturing.

Product Overview: Imipenem + Cilastatin inhibits bacterial cell wall synthesis by targeting penicillin-binding proteins, causing bacterial lysis. Cilastatin prevents renal degradation of imipenem, prolonging its activity. Benefits include rapid, broad-spectrum action against resistant bacteria, effective in severe infections like pneumonia and sepsis, and reliable bacterial eradication when used appropriately in clinical settings. Imipenem + Cilastatin powder for reconstitution is approved in the EU and US for treating severe bac...

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

Imipenem + Cilastatin Powder for Reconstitution 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 Imipenem + Cilastatin Powder for Reconstitution 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 Imipenem + Cilastatin Powder for Reconstitution is more than procurement—it’s a strategic partnership. With its powder for reconstitution form and 500 mg/500 mg, 1 g/1 g in vials 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 Imipenem + Cilastatin Powder for Reconstitution