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:
Irritable Bowel Syndrome (IBS): Reduces cramping in 89% of patients (Clinical Gastroenterology, 2023)
Renal/Biliary Colic: 30% faster onset vs. dicyclomine
Diagnostic Prep: Optimized for endoscopy/radiography procedures
High-Purity API: ≥99.5% HPLC-grade Hyoscine Bromide
Enhanced Bioavailability: ≥85% dissolution in 30 minutes (USP/EP compliant)
Patient-Centric Design: Scored tablets for accurate dose splitting
GMP-Certified Production: Full traceability from raw materials to finished product
Scalable Quantities: Batches from 100,000 to 3 million tablets
Flexible Packaging:
Alu-Alu blisters (10–100 tablets)
HDPE bottles (100–500 tablets)
Custom branding available
Active DMF/ASMF/CEP for US, EU, and emerging markets
Stability Studies: ICH-compliant 24-month data
Documentation: Batch-specific CoA, residual solvent reports, BSE/TSE declarations
| Parameter | Specification |
|---|---|
| Dosage Form | Immediate-release tablet |
| Appearance | White, scored |
| Heavy Metals | ≤20 ppm |
| Water Content | ≤5.0% w/w |
| Residual Solvents | Meets ICH Q3C |
Bioequivalent formulations to streamline ANDA approvals
Cost-effective MOQs (100K tablets) with bulk discounts
Ready-to-market finished dosage forms
Cold-chain logistics for global delivery
White-label solutions
Regulatory dossier support (IMPD, CTD modules)
Proven Clinical Efficacy: 72% reduction in cramp intensity within 30 minutes
Supply Chain Resilience: Dual API sourcing to mitigate shortages
Sustainability: Eco-friendly packaging options
Lead Time: 4–6 weeks (standard orders)
Samples: Available for qualified partners
Documentation: Includes CoA, GMP certificates, and export licenses
Available for distributors, hospitals, and generic drug manufacturers
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