Calcifediol

Form: ER Oral Capsule

Strength: 30 mcg

Reference Brands: Rayaldee®(US)

Category: Nephrology

Calcifediol (25-hydroxyvitamin D3) products are regulated in the EU and US, with dossiers demonstrating safety, efficacy, and manufacturing quality under GMP standards. In the US, FDA approval involves validation, safety testing, and clinical data, while in the EU, CE marking certifies conformity with MDR standards. These products undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality calcifediol formulations supporting vitamin D deficiency correction and bone health management worldwide.