How to Source Dolutegravir + Rilpivirine for Pharmaceutical Formulation
Dolutegravir + Rilpivirine (Tablet, 50 mg / 25 mg) is classified under Anti Viral. It is therapeutically aligned with reference brands such as Juluca(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Dolutegravir + Rilpivirine for formulation, R&D, or bulk manufacturing.
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
Dolutegravir + Rilpivirine 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 Dolutegravir + Rilpivirine 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 Dolutegravir + Rilpivirine is more than procurement—it’s a strategic partnership. With its tablet form and 50 mg / 25 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 Dolutegravir + Rilpivirine
What is the typical lead time for Dolutegravir + Rilpivirine?
Lead times range from 4–6 weeks depending on supplier and region.
Is Dolutegravir + Rilpivirine available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Dolutegravir + Rilpivirine require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Dolutegravir + Rilpivirine?
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 Dolutegravir + Rilpivirine?
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 Dolutegravir + Rilpivirine?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Dolutegravir + Rilpivirine suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Dolutegravir + Rilpivirine 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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