How to Source Enalapril tablets for Pharmaceutical Formulation
Enalapril tablets (Tablet, 2.5 mg, 5 mg, 10 mg, 20 mg) is classified under Medical Aid. It is therapeutically aligned with reference brands such as Vasotec(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Enalapril tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Enalapril tablets are ACE inhibitors that block the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. Benefits include lowering blood pressure, reducing heart failure symptoms, preventing strokes, and protecting kidney function, thereby improving cardiovascular health and decreasing the risk of hypertension-related complications.
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
Enalapril tablets 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 Enalapril tablets 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 Enalapril tablets is more than procurement—it’s a strategic partnership. With its tablet form and 2.5 mg, 5 mg, 10 mg, 20 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 Enalapril tablets.
Frequently Asked Questions For Sourcing of Enalapril tablets
What is the typical lead time for Enalapril tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Enalapril tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Enalapril tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Enalapril tablets?
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 Enalapril tablets?
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 Enalapril tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Enalapril tablets suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Enalapril tablets 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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