How to Source Pirfenidone Tablet for Pharmaceutical Formulation

Pirfenidone Tablet (Tablet, 267 mg , 801 mg) is classified under Respiratory Disorder. It is therapeutically aligned with reference brands such as Esbriet(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Pirfenidone Tablet for formulation, R&D, or bulk manufacturing.

Product Overview: Pirfenidone is an oral antifibrotic medication used to treat idiopathic pulmonary fibrosis (IPF). It slows lung scarring, improves lung function, and reduces inflammation. Marketed as Esbriet in the US and EU, it’s taken three times daily. Common side effects include nausea, rash, and liver enzyme changes. Pirfenidone is an FDA- and EMA-approved oral antifibrotic drug used to treat idiopathic pulmonary fi...

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

Pirfenidone Tablet 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 Pirfenidone Tablet 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 Pirfenidone Tablet is more than procurement—it’s a strategic partnership. With its tablet form and 267 mg , 801 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 Pirfenidone Tablet