Composition: Each film-coated sustained-release tablet contains Nifedipine IP 10 mg or 20 mg. DOFEDIN contains Nifedipine BP 20 mg with excipients q.s.
Dosage form: Film-coated sustained-release oral tablets
Usage: Long-term management of hypertension and selected angina indications as prescribed.
Category: Anti Cardiovascular Drugs
Therapeutic category: Dihydropyridine Calcium Channel Blocker / Antihypertensive
Brand: DOFEDIN (BP 20 mg variant)
SKU: Nifedipine Sustained Release Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Nifedipine Extended Release Tablets Exporter is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification requires verification)
Exporter: Healthy Inc (Star Export House status requires verification)
Nifedipine is a dihydropyridine calcium channel blocker used to manage high blood pressure and certain forms of angina. Sustained-release (SR) tablets are designed to release nifedipine over time; they are not interchangeable with immediate-release or other modified-release products without a prescriber's review.
Supplied variants include film-coated IP 10 mg and 20 mg tablets and the DOFEDIN BP 20 mg formulation. Manufacturing and export capabilities should be confirmed against current product and facility documentation.
| Product name | Nifedipine Sustained Release Tablets |
|---|---|
| Active ingredient | Nifedipine (CAS 21829-25-4) |
| Confirmed strengths | 10 mg and 20 mg |
| IP 10 mg | Each film-coated SR tablet contains Nifedipine IP 10 mg |
| IP 20 mg | Each film-coated SR tablet contains Nifedipine IP 20 mg |
| DOFEDIN BP 20 mg | Each film-coated SR tablet contains Nifedipine BP 20 mg; excipients q.s. |
| Dosage form | Film-coated sustained-release oral tablet |
| Pharmacopoeial standards | IP or BP, according to the supplied variant; compliance to be confirmed by product testing |
| Therapeutic class | Calcium channel blocker / antihypertensive / antianginal |
| 30 mg strength | Mentioned in marketing description but not supported by supplied composition |
| Shelf life and pack sizes | To be confirmed from approved stability studies and packaging specification |
Nifedipine is sensitive to light, and a sustained-release dosage form requires a validated release-controlling formulation. Appropriate controls may include light-protective handling, qualified coating and compression processes, and packaging selected from stability evidence. Specific polymer matrices, lighting systems, equipment and manufacturing conditions have not been independently verified for these products.
Product-specific quality control should cover identification, assay, uniformity of dosage units, impurities (including light-induced degradation products), physical integrity and a validated multi-time-point dissolution profile appropriate to the approved SR formulation. Numerical acceptance criteria must follow the applicable registered specification rather than assumed universal limits.
Nifedipine blocks L-type calcium channels in vascular smooth muscle, relaxing arteries and lowering peripheral vascular resistance. Approved SR formulations may be used for hypertension and selected angina conditions. This product is not intended for immediate relief of an acute hypertensive emergency or sudden chest pain. Raynaud's phenomenon may be an off-label use depending on jurisdiction.
For commercial enquiries, request the current product registration status, approved label, certificate of analysis, stability information, packaging details, GMP evidence and export permissions applicable to the destination market. Availability of CTD/ACTD dossiers, FSC, COPP, particular shipping terms and specific certifications should be confirmed directly with the supplier.
Q: What strengths are listed?
A: IP 10 mg, IP 20 mg and DOFEDIN BP 20 mg.
Q: Can an SR tablet be crushed or split?
A: Do not crush or chew. Split only if the specific approved product label explicitly permits it, because altering a modified-release tablet can change drug delivery.
Q: Is it for a sudden blood pressure spike?
A: No. It is intended for ongoing treatment, not emergency blood pressure reduction.
Q: Is grapefruit juice a concern?
A: Yes. Grapefruit may increase nifedipine exposure; patients should follow their prescriber's and product-label advice.
Use only as prescribed. Dose and frequency depend on the exact sustained-release formulation, indication, patient response and approved product label; different nifedipine extended-release products are not automatically interchangeable. Swallow whole with water unless the specific label states otherwise. Do not stop or change treatment without medical advice.
Possible adverse effects include headache, flushing, dizziness, low blood pressure, palpitations and peripheral ankle swelling. Gingival overgrowth may occur. Seek urgent medical care for fainting, severe hypotension, worsening chest pain or allergic symptoms. Review interactions with grapefruit, strong CYP3A4 inhibitors/inducers and other blood-pressure-lowering medicines. Monitor blood pressure as directed.
Protect from light and moisture and store according to the approved product label and validated stability conditions. Keep tablets in their original packaging until use and out of reach of children. A specific temperature limit cannot be confirmed from the supplied composition alone.
Medical disclaimer: Prescription medicine. This information is for product identification and general reference, not individual medical advice. Use the approved prescribing information for clinical decisions.