Rosuvastatin 20 mg Tablets | High-Potency GMP-Certified FDF

Product Overview

Vonage Pharma’s Rosuvastatin 20 mg tablets deliver maximum-efficacy treatment for severe hypercholesterolemia in Cardiovascular category. As the highest commercially available dose, this GMP-manufactured FDF offers:

• 60% LDL reduction – Superior efficacy vs. lower doses (ACC 2023 data)
• Bioequivalence to reference brands (AUC 0.90-1.10)
• 24-month shelf life with ICH stability documentation
• Regulatory-ready: Full CMC dossier for ANDA/EMA submissions

Therapeutic Applications:

• Severe primary hypercholesterolemia (LDL >190 mg/dL)

• High-risk CVD patients requiring aggressive LDL lowering

• Genetic dyslipidemias (e.g., familial hypercholesterolemia)

Technical Specifications of Rosuvastatin 20 mg

Core Parameters

Enhanced Stability Profile of Rosuvastatin 20 mg

• Shelf life: 24 months at 25°C/60% RH

• Packaging:

  • Alu-Alu blisters (10/30/100 count) – UV-protective

  • HDPE bottles (100/500/1000 count) with tamper-evident seals

Manufacturing & Commercial Advantages

Production Capabilities

• Batch sizes: 100K–3M tablets (larger MOQs vs. 10 mg)

• Excipients: Lactose-free formulation available

• Quality controls:

  • Hardness 60-100 N (reinforced for high-dose integrity)

  • Friability ≤0.8%

Regulatory Support

• Active ASMF

• US DMF Type II available

• Prequalified excipients: Microcrystalline cellulose (PH-102), croscarmellose sodium

Supply Chain Reliability

• Lead time: 6 weeks (express options for 1M+ units)

• Cold-chain logistics: For tropical climates

Why Partner for Rosuvastatin 20 mg?

For Generic Manufacturers

• ANDA acceleration: Comparative dissolution profiles

• Cost advantage: 18% lower COGS vs. EU competitors

Hospital Procurement

• High-dose preference: 72% of cardiologists prescribe 20 mg for severe cases

• Bulk packaging: 1,000-count bottles for institutional use

For Export Markets

• WHO-compliant documentation

• Halal/Kosher certification available

Ordering & Samples of Rosuvastatin 20 mg

• MOQ: 100,000 tablets

• Samples: 50 units for quality validation

• Documentation: Batch records, CoA, GMP certificates