How to Source PIRFENIDONE Capsule for Pharmaceutical Formulation

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

Product Overview: Tablet contains pirfenidone. It is used to treat idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a type of lung disorder in which tissues of the lungs become scarred and inflamed, resulting in breathing difficulties. This medicine should not be used if you have severe liver disorders, severe kidney disorders, if you are taking fluvoxamine (treats depression and obsessive compulsive disorder), or if you are allergic to any of the ingredients of this medicine. This medicine is not recommended for adolescents and children under the age of 18. Avoid smoking as...

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 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 PIRFENIDONE 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 PIRFENIDONE Capsule is more than procurement—it’s a strategic partnership. With its capsules form and 267 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 Capsule