How to Source Indinavir Sulphate for Pharmaceutical Formulation
Indinavir Sulphate (Capsules, 200 mg, 400 mg) is classified under Anti Viral. It is therapeutically aligned with reference brands such as Crixivan®(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Indinavir Sulphate for formulation, R&D, or bulk manufacturing.
Product Overview:
Indinavir Capsules (200 mg, 400 mg), known as Crixivan® or Indivan®, are protease inhibitors used for HIV-1 treatment. Though less common today, they remain available for procurement on PharmaB2B platforms from WHO-GMP manufacturers—ideal for tenders, legacy treatment, and global HIV access programs.
Indinavir Sulphate Capsules, marketed under brands like Crixivan® and Indivan®, are protease...
Indinavir Sulphate API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
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
Indinavir Sulphate 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 Indinavir Sulphate is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Indinavir Sulphate is more than procurement—it’s a strategic partnership. With its capsules form and 200 mg, 400 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.
Next Step: Get expert assistance in sourcing Indinavir Sulphate.
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Frequently Asked Questions For Sourcing of Indinavir Sulphate
What is the typical lead time for Indinavir Sulphate?
Lead times range from 4–6 weeks depending on supplier and region.
Is Indinavir Sulphate available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Indinavir Sulphate require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Indinavir Sulphate?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Indinavir Sulphate?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Indinavir Sulphate?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Indinavir Sulphate suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Indinavir Sulphate be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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