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Hyoscine Bromide 10 mg Tablets | GMP-Certified Antispasmodic

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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:

  • 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

Key Features & Benefits of Hyoscine Bromide 10 mg

1. Superior Formulation Quality

  • 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

2. Reliable Manufacturing & Supply

  • 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

3. Regulatory & Compliance Ready

  • 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

Technical Specifications of Hyoscine Bromide 10 mg

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

Why Choose Vonage Pharma?

For Generic Drug Manufacturers

  • Bioequivalent formulations to streamline ANDA approvals

  • Cost-effective MOQs (100K tablets) with bulk discounts

Distributors & Hospitals

  • Ready-to-market finished dosage forms

  • Cold-chain logistics for global delivery

For Contract Manufacturing Partners

  • White-label solutions

  • Regulatory dossier support (IMPD, CTD modules)

Market Differentiators

  • 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

Ordering & Compliance of Hyoscine Bromide 10 mg

  • Lead Time: 4–6 weeks (standard orders)

  • Samples: Available for qualified partners

  • Documentation: Includes CoA, GMP certificates, and export licenses

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Available for distributors, hospitals, and generic drug manufacturers

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