Hyoscine Bromide 10 mg: Product Overview
Vonage Pharma’s Hyoscine Bromide 10 mg tablets are a clinically proven antispasmodic solution for gastrointestinal disorders, manufactured under strict GMP compliance for global pharmaceutical partners. This immediate-release formulation delivers rapid relief from abdominal cramps, IBS symptoms, and biliary colic, with 24-month shelf stability and batch-to-batch consistency.
Therapeutic Applications:
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Irritable Bowel Syndrome (IBS): Reduces cramping in 89% of patients (Clinical Gastroenterology, 2023)
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Renal/Biliary Colic: 30% faster onset vs. dicyclomine
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Diagnostic Prep: Optimized for endoscopy/radiography procedures
Key Features & Benefits of Hyoscine Bromide 10 mg
1. Superior Formulation Quality
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High-Purity API: ≥99.5% HPLC-grade Hyoscine Bromide
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Enhanced Bioavailability: ≥85% dissolution in 30 minutes (USP/EP compliant)
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Patient-Centric Design: Scored tablets for accurate dose splitting
2. Reliable Manufacturing & Supply
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GMP-Certified Production: Full traceability from raw materials to finished product
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Scalable Quantities: Batches from 100,000 to 3 million tablets
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Flexible Packaging:
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Alu-Alu blisters (10–100 tablets)
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HDPE bottles (100–500 tablets)
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Custom branding available
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3. Regulatory & Compliance Ready
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Active DMF/ASMF/CEP for US, EU, and emerging markets
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Stability Studies: ICH-compliant 24-month data
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Documentation: Batch-specific CoA, residual solvent reports, BSE/TSE declarations
Technical Specifications of Hyoscine Bromide 10 mg
Parameter | Specification |
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Dosage Form | Immediate-release tablet |
Appearance | White, scored |
Heavy Metals | ≤20 ppm |
Water Content | ≤5.0% w/w |
Residual Solvents | Meets ICH Q3C |
Why Choose Vonage Pharma?
For Generic Drug Manufacturers
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Bioequivalent formulations to streamline ANDA approvals
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Cost-effective MOQs (100K tablets) with bulk discounts
Distributors & Hospitals
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Ready-to-market finished dosage forms
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Cold-chain logistics for global delivery
For Contract Manufacturing Partners
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White-label solutions
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Regulatory dossier support (IMPD, CTD modules)
Market Differentiators
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Proven Clinical Efficacy: 72% reduction in cramp intensity within 30 minutes
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Supply Chain Resilience: Dual API sourcing to mitigate shortages
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Sustainability: Eco-friendly packaging options
Ordering & Compliance of Hyoscine Bromide 10 mg
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Lead Time: 4–6 weeks (standard orders)
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Samples: Available for qualified partners
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Documentation: Includes CoA, GMP certificates, and export licenses
Get Started
Available for distributors, hospitals, and generic drug manufacturers
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