How to Source Nifedipine tablets(IR/ER) for Pharmaceutical Formulation
Nifedipine tablets(IR/ER) (Tablet(IR & ER), 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Procardia(US);. This guide highlights key sourcing factors buyers should consider when procuring high-quality Nifedipine tablets(IR/ER) for formulation, R&D, or bulk manufacturing.
Product Overview:
Nifedipine is a calcium channel blocker that relaxes blood vessels by inhibiting calcium entry into vascular smooth muscle. It lowers blood pressure, relieves angina, and improves blood flow. Benefits include rapid symptom relief, reduced cardiac workload, and support for long-term cardiovascular health in hypertension and angina management.
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
Nifedipine tablets(IR/ER) 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 Nifedipine tablets(IR/ER) 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 Nifedipine tablets(IR/ER) is more than procurement—it’s a strategic partnership. With its tablet(ir & er) form and 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms) 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 Nifedipine tablets(IR/ER).
Frequently Asked Questions For Sourcing of Nifedipine tablets(IR/ER)
What is the typical lead time for Nifedipine tablets(IR/ER)?
Lead times range from 4–6 weeks depending on supplier and region.
Is Nifedipine tablets(IR/ER) available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Nifedipine tablets(IR/ER) require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Nifedipine tablets(IR/ER)?
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 Nifedipine tablets(IR/ER)?
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 Nifedipine tablets(IR/ER)?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Nifedipine tablets(IR/ER) suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Nifedipine tablets(IR/ER) be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.