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Cardiovascular

Rosuvastatin Calcium API Manufacturer India

CAS 147098-20-2 · Manufactured by Reine Lifescience, Ankleshwar, Gujarat, India
IP, BP, EP, USP✓ DMF FiledCardiovascular
Rosuvastatin Calcium (CAS 147098-20-2) is a cardiovascular active pharmaceutical ingredient manufactured by Reine Lifescience in Ankleshwar, Gujarat, India, supplied in IP, BP, EP and USP grades, with a DMF on file.

Overview

A potent statin class lipid-lowering agent for hypercholesterolemia, mixed dyslipidemia, and cardiovascular disease prevention. Selective HMG-CoA reductase inhibitor. Available in Amorphous Form. CEP Under Approval (CEP-2025-505) and MFDS Korea Approved.

Rosuvastatin Calcium chemical structure

Specifications

CAS Number147098-20-2
Therapeutic CategoryCardiovascular
Pharmacopoeia GradeIP, BP, EP, USP
DMF StatusFiled
Manufactured ByReine Lifescience, India

Regulatory & Compliance

WHO-GMP Certified Manufacturing Facility

WHO-GMP Certified Manufacturing Facility

World Health Org. Good Manufacturing Practice — Certified Facility
EDQM CEP Certified

EDQM CEP Certified

Certificate of Suitability (EDQM) — CEP-2025-505 Approved
Korea MFDS Approved

Korea MFDS Approved

Korea Ministry of Food & Drug Safety — Korea MFDS Approved
ANVISA Brazil — Approved

ANVISA Brazil — Approved

Brazilian Health Regulatory Agency

Frequently Asked Questions

What is the CAS number of Rosuvastatin Calcium?

The CAS number of Rosuvastatin Calcium is 147098-20-2.

Which pharmacopoeia grades of Rosuvastatin Calcium does Reine Lifescience supply?

Reine Lifescience supplies Rosuvastatin Calcium in IP, BP, EP and USP grades.

Does Reine Lifescience have a DMF for Rosuvastatin Calcium?

Yes, Reine Lifescience has filed a Drug Master File (DMF) for Rosuvastatin Calcium.

What regulatory approvals does Rosuvastatin Calcium have?

Rosuvastatin Calcium is backed by: WHO-GMP Certified Manufacturing Facility, EDQM CEP Certified, Korea MFDS Approved, ANVISA Brazil — Approved.

How do I request a quote for Rosuvastatin Calcium?

Fill the enquiry form on this page, or contact Reine Lifescience with the product name, grade and required quantity.

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About Reine Lifescience
Devoted to Life
Reine Lifescience is a WHO-GMP and EDQM CEP accredited active pharmaceutical ingredient manufacturer based in Ankleshwar, Gujarat, India, manufacturing Rosuvastatin Calcium and a portfolio of APIs for pharmaceutical partners worldwide.
Approvals for Rosuvastatin Calcium
WHO-GMP Certified Manufacturing FacilityWHO-GMP Certified Manufacturing Facility
EDQM CEP CertifiedEDQM CEP Certified
Korea MFDS ApprovedKorea MFDS Approved
ANVISA Brazil — ApprovedANVISA Brazil — Approved
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