Rosuvastatin 10 mg Tablets | GMP-Certified Finished Dosage Form

Product Overview of Rosuvastatin 10 mg

Vonage Pharma’s Rosuvastatin 10 mg tablets are a high-potency, film-coated statin formulation designed for optimal cholesterol management in Cardiovascular disorders. Manufactured in our EU GMP-certified facility, these ready-to-market tablets offer:

• Clinically proven efficacy: 55% LDL cholesterol reduction vs. placebo (AHA 2023 guidelines)

• Bioequivalence: Comparable pharmacokinetics to reference brands (Cmax 0.95-1.05, AUC 0.90-1.10)

• Patient-centric design: Film-coated for easier swallowing, scored for dose flexibility

• Regulatory compliance: Full documentation for ANDA/EMA submissions

Therapeutic Applications:

• Primary hypercholesterolemia (Type IIa/IIb)

• Mixed dyslipidemia

• Atherosclerosis prevention in high-risk patients

Technical Specifications

Core Parameters

Stability & Packaging of Rosuvastatin 10 mg

• Shelf life: 24 months at 25°C/60% RH (ICH accelerated stability data available)

• Primary packaging:

  • Alu-Alu blisters (10/30/100 tablets per strip)

  • HDPE bottles (100/500/1000 tablets) with induction seals

• Secondary packaging: Customizable carton labeling

Manufacturing & Supply Advantages

Production Capabilities

• Batch sizes: 100,000 to 5 million tablets

• Capacity: 10 million tablets/month

• Excipients: USP/EP-grade, with lactose-free options

Quality Assurance of Rosuvastatin 10 mg

• In-process controls: Weight variation ±5%, hardness 50-80 N

• Full traceability: Batch-specific Certificate of Analysis

• Compliance: Meets USP/EP/BP monographs

Global Supply Chain

• Lead time: 6-8 weeks (standard orders)

• Logistics: GDP-compliant, cold-chain available

• Documentation: Export licenses, GMP certificates

Commercial Offerings

For Generic Manufacturers

• ANDA submission support: Comparative dissolution profiles

• Cost savings: 15-20% below EU market prices for 1M+ units

Distributors

• Private labeling: Custom branding/artwork

• Tender participation support

For Hospital Groups

• Batch reservation for formulary inclusion

• Bulk packaging for institutional use

Ordering Information of Rosuvastatin 10 mg

• MOQ: 100,000 tablets

• Samples: Available for quality validation

• Payment terms: LC/TT negotiable