Product/Composition:- | Diltiazem tablets/capsules |
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Strength:- | IR: 0 mg, 60 mg, 90 mg, 120 mg; SR: Up to 540 mg |
Form:- | Tablet/Capsules |
Reference Brands:- | Cardizem(US); Dilzem(EU) |
MOQ | As per the manufacturer batch size |
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Diltiazem is a calcium channel blocker that relaxes blood vessels and reduces heart rate by inhibiting calcium entry into cardiac and vascular smooth muscle cells. It effectively treats hypertension, angina, and arrhythmias, providing benefits like lowered blood pressure, decreased chest pain, rhythm stabilization, and improved overall cardiovascular health.
Diltiazem tablets and capsules, marketed as Cardizem and Dilzem, are approved in the US by the FDA and in the EU via EMA for hypertension, angina, and arrhythmias. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, FDA reviews clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional compliance supports timely approval, safe use, and global availability, enabling effective cardiovascular management worldwide.