How to Source Sacubitril + Valsartan tablet for Pharmaceutical Formulation
Sacubitril + Valsartan tablet (Tablet, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Entresto: (US and EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Sacubitril + Valsartan tablet for formulation, R&D, or bulk manufacturing.
Product Overview:
Sacubitril + Valsartan tablets combine an angiotensin receptor blocker with a neprilysin inhibitor, boosting natriuretic peptides and reducing blood pressure. They improve heart failure symptoms, decrease hospitalizations, and enhance survival rates. Benefits include better cardiac function, reduced strain, and improved quality of life for heart failure patients.
Sacubitril + Valsartan tablet 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
Sacubitril + Valsartan 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 Sacubitril + Valsartan tablet 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 Sacubitril + Valsartan tablet is more than procurement—it’s a strategic partnership. With its tablet form and 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 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 Sacubitril + Valsartan tablet.
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Frequently Asked Questions For Sourcing of Sacubitril + Valsartan tablet
What is the typical lead time for Sacubitril + Valsartan tablet?
Lead times range from 4–6 weeks depending on supplier and region.
Is Sacubitril + Valsartan tablet available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Sacubitril + Valsartan tablet require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Sacubitril + Valsartan tablet?
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 Sacubitril + Valsartan tablet?
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 Sacubitril + Valsartan tablet?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Sacubitril + Valsartan tablet suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Sacubitril + Valsartan tablet 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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