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.
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.
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.