Hyoscine Butylbromide

Hyoscine Butylbromide, also known as scopolamine butylbromide, is an antispasmodic and anticholinergic drug widely used for the treatment of gastrointestinal (GI) and genitourinary tract spasms, irritable bowel syndrome (IBS), and menstrual cramps. With its ability to relax smooth muscles in the abdominal region, Hyoscine Butylbromide has remained a staple in symptomatic relief therapy for decades. It is listed in many national formularies and often prescribed as a first-line medication for colicky pain and cramping.

At BluepillExpress, we are proud to offer WHO-GMP compliant third-party manufacturing of Hyoscine Butylbromide in multiple dosage forms, customized packaging formats, and full-scale regulatory support to serve diverse global markets. Our manufacturing excellence, quality commitment, and export readiness make us a dependable partner for pharmaceutical brands and healthcare organizations.

About BluepillExpress

BluepillExpress is a global pharmaceutical manufacturer and exporter offering end-to-end third-party manufacturing services for a wide array of therapeutic categories. With WHO-GMP certified infrastructure and exports to over 25 countries across Asia, Africa, CIS, Latin America, and the Middle East, BluepillExpress delivers quality-driven pharmaceutical solutions that are compliant, scalable, and cost-effective.

We specialize in:

• Generic drug manufacturing
• Custom formulation development
• Private label and contract manufacturing
• Export-oriented regulatory documentation
• Supply chain management and global logistics

Our focus is to provide clients with reliable pharmaceutical manufacturing tailored to their business model and market needs.

Product Overview: Hyoscine Butylbromide

Hyoscine Butylbromide is a quaternary ammonium compound derived from scopolamine. It works by blocking muscarinic receptors in smooth muscles, thereby reducing involuntary muscle contractions in the gastrointestinal, urinary, and reproductive tracts.

It is used primarily for:

• Relief of abdominal cramps and spasmodic pain
• Irritable bowel syndrome (IBS)
• Menstrual pain (dysmenorrhea)
• Spasms of the urinary tract or gall bladder
• Supportive therapy in gastrointestinal disorders

Its efficacy and fast onset of action make it a preferred choice in emergency settings and outpatient care for functional abdominal complaints.

Pharmacology and Mechanism of Action

Hyoscine Butylbromide acts by competitively antagonizing the muscarinic acetylcholine receptors (M1 to M5) on smooth muscles. This blocks parasympathetic nerve impulses, leading to relaxation of smooth muscle fibers and a consequent reduction in spasms and pain.

Being a quaternary ammonium compound, it does not cross the blood-brain barrier, minimizing central nervous system side effects and making it safer for a broad patient population, including the elderly.

Therapeutic Indications

• Abdominal and GI cramps
• Functional gastrointestinal disorders (e.g., IBS)
• Spasms of the biliary tract (e.g., cholelithiasis)
• Menstrual pain
• Spastic dysmenorrhea
• Urinary tract spasms
• Pre-procedural sedation or diagnostic interventions (e.g., endoscopy, radiology)

Dosage Forms Available

BluepillExpress offers Hyoscine Butylbromide in a range of dosage forms suitable for both acute and chronic management of spasmodic conditions. Our formulations comply with pharmacopoeial standards (IP, BP, USP, Ph. Eur.) and are manufactured with high-grade APIs and excipients.

1. Tablets

• 10 mg
• Film-coated for easy swallowing
• Packed in blister or strip formats
• Suitable for outpatient and chronic therapy

2. Injectable Solution

• 20 mg/ml in 1 ml or 2 ml ampoules
• For intramuscular, subcutaneous, or slow intravenous administration
• Sterile, clear solution in amber or clear glass ampoules
• Used in emergency settings and hospital care

3. Combination Formulations (available on request)

• Hyoscine Butylbromide + Paracetamol (for pain relief)
• Hyoscine Butylbromide + Diclofenac (for dysmenorrhea)
• Available in co-blister packs or as fixed-dose tablets

Manufacturing Process and Infrastructure

At BluepillExpress, our production units are built to meet global compliance standards and facilitate high-precision manufacturing for both oral and injectable formulations. Our key capabilities include:

• Automated tablet compression and coating systems
• Sterile ampoule filling and sealing lines
• Granulation, blending, and sieving equipment
• Dehumidified cleanrooms (ISO Class 7 & 8)
• Water purification systems (RO + UV + EDI)
• Modern HVAC systems to ensure environmental control
• Validated batch production and documentation systems

We operate under strict Standard Operating Procedures (SOPs) and batch monitoring to ensure consistency and quality across every batch.

Quality Assurance and Control

BluepillExpress adheres to a comprehensive Quality Management System (QMS), integrating in-process controls, finished product testing, and stability studies.

Our QA/QC practices include:

• Raw material verification (identity, assay, microbial load)
• In-process testing (tablet weight, friability, pH, sterility)
• Finished product testing:
  • Assay of active ingredients
  • Impurity profiling
  • Dissolution and disintegration
  • Microbiological limits
  • Container-closure integrity
• Accelerated and real-time stability studies as per ICH guidelines

Each batch is released only after thorough inspection, and a Certificate of Analysis (CoA) is provided with every shipment.

Packaging Solutions

We offer customized, export-ready packaging to suit client branding and regulatory requirements.

Tablet Packaging:

• Blister (PVC/Alu or Alu-Alu) packs
• Strip packs with high-barrier foil
• Mono cartons with printed inserts
• Bulk bottles or HDPE jars for institutional use

Injection Packaging:

• Glass ampoules (clear or amber)
• Packs of 5, 10, or 25 ampoules per tray
• Outer cartons with multilingual labeling
• Tamper-evident and light-protective packaging

All packaging materials are sourced from certified suppliers and tested for stability, compatibility, and user convenience.

Regulatory and Documentation Support

To ensure smooth market entry and tender participation, BluepillExpress provides a complete set of regulatory documents and dossiers, including:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Free Sale Certificate
• Stability data and validation reports
• CTD or ACTD format dossiers for regulatory filing
• Material Safety Data Sheet (MSDS)
• Batch Manufacturing Records (BMR)

We also assist in customizing packaging, artwork, and labeling as per country-specific regulations (FDA, TGA, NDA, PPB, ANVISA, etc.).

Global Export and Logistics

BluepillExpress serves clients in over 25 countries with reliable and efficient export services. Our logistics team manages all aspects of international trade, from packaging to delivery.

Our export services include:

• Multilingual labeling and inserts
• Temperature-controlled supply chain (for injectables)
• Air and sea freight with insurance
• Customs clearance and regulatory liaison
• Country-specific serialization and tracking
• Documentation as per import regulations

We maintain a strong presence in:

• Africa: Nigeria, Ghana, Kenya, South Africa
• Asia: Bangladesh, Myanmar, Vietnam, Sri Lanka
• CIS: Uzbekistan, Georgia, Kyrgyzstan
• Middle East: UAE, Iraq, Jordan, Yemen
• Latin America: Peru, Bolivia, Dominican Republic

Ideal Clients for Third-Party Manufacturing

Our Hyoscine Butylbromide manufacturing is best suited for:

• Generic drug marketers
• OTC pharmaceutical companies
• Public healthcare procurement agencies
• NGOs and government tenders
• Hospital and clinical distributors
• E-commerce and digital health platforms
• Multinational pharmaceutical repackagers

We support both small batch production for startups and bulk supply for institutional tenders, offering competitive pricing and full branding support.

Why Choose BluepillExpress?

1. WHO-GMP Certified Manufacturing
   Global compliance with WHO, ISO, and GLP standards.
2. Scalable Manufacturing Capacity
   Capable of handling bulk orders and small-scale custom runs.
3. Global Regulatory Documentation
   Ready dossiers for registrations in multiple markets.
4. Custom Branding and Private Labeling
   Your brand, your packaging, our manufacturing.
5. Proven Export Network
   25+ countries, seamless shipping, customs support.
6. Uncompromised Quality Assurance
   End-to-end testing and validation for every batch.
7. Competitive Pricing and Flexible MOQs
   Supporting businesses of every scale with tailored quotes.

Conclusion

Hyoscine Butylbromide remains a crucial antispasmodic medication in gastrointestinal, gynecological, and urological care. Its broad applications and minimal side-effect profile make it an essential medicine in many global markets.

By partnering with BluepillExpress, you gain a technologically advanced, regulatory-compliant, and export-ready manufacturing solution for Hyoscine Butylbromide. Whether you’re an established brand expanding into new markets or a startup looking for quality-assured production, our team is ready to deliver excellence from concept to container.