Diltiazem tablets/capsules
Form: Tablet/Capsules
Strength: IR: 0 mg, 60 mg, 90 mg, 120 mg; SR: Up to 540 mg
Reference Brands: Cardizem(US); Dilzem(EU)
Category: Heart Disorder
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Related Products
Aliskiren tablets
Strength: 150 mg, 300 mg
Form: Tablets
Reference Brands: Tekturna(US & EU)
View Details Get Enquiry
Atenolol tablets
Strength: 25 mg, 50 mg, 100 mg
Form: Tablets
Reference Brands: Tenormin(US)
View Details Get Enquiry
Metoprolol Tartrate tablet
Strength: IR: 25 mg, 50 mg, 100 mg; ER: 25 mg, 50 mg, 100 mg, 200 mg
Form: Tablets(IR & ER)
Reference Brands: US: Lopressor(IR); Toprol-XL(ER)
View Details Get EnquiryNifedipine tablets(IR/ER)
Strength: 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)
Form: Tablet(IR & ER)
Reference Brands: Procardia(US);
View Details Get Enquiry