How to Source Apremilast for Pharmaceutical Formulation

Apremilast (Tablets, 10 mg, 20 mg, 30 mg) is classified under Immune Disorder. It is therapeutically aligned with reference brands such as Otezla(USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Apremilast for formulation, R&D, or bulk manufacturing.

Product Overview: Apremilast, marketed under the brand name Otezla, is an FDA-approved small-molecule phosphodiesteras...

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

Apremilast 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 Apremilast 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 Apremilast is more than procurement—it’s a strategic partnership. With its tablets form and 10 mg, 20 mg, 30 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 Apremilast