How to Source Cefepime (4th Gen) Injectable (IV/IM) for Pharmaceutical Formulation

Cefepime (4th Gen) Injectable (IV/IM) (Injectable (IV/IM), 1 g, 2 g, 4 g per vial) is classified under Antibiotics. It is therapeutically aligned with reference brands such as Maxipime(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Cefepime (4th Gen) Injectable (IV/IM) for formulation, R&D, or bulk manufacturing.

Product Overview: Cefepime inhibits bacterial cell wall synthesis by targeting penicillin-binding proteins, causing bacterial lysis. It is effective against multi-drug resistant gram-negative bacteria, including Pseudomonas. Benefits include rapid bacterial eradication, broad-spectrum activity, and use in severe infections like pneumonia and sepsis, especially in hospital settings for critical cases. Cefepime IV injection is approved in the EU and US for treating severe bacterial infections, includi...

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

Cefepime (4th Gen) Injectable (IV/IM) 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 Cefepime (4th Gen) Injectable (IV/IM) 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 Cefepime (4th Gen) Injectable (IV/IM) is more than procurement—it’s a strategic partnership. With its injectable (iv/im) form and 1 g, 2 g, 4 g per vial 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 Cefepime (4th Gen) Injectable (IV/IM)