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Suppliers and packagers for METHSCOPOLAMINE BROMIDE
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METHSCOPOLAMINE BROMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Breckenridge Pharm | METHSCOPOLAMINE BROMIDE | methscopolamine bromide | TABLET;ORAL | 040642 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-191-01 | 100 TABLET in 1 BOTTLE (51991-191-01) | 2012-05-21 |
| Breckenridge Pharm | METHSCOPOLAMINE BROMIDE | methscopolamine bromide | TABLET;ORAL | 040642 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-192-06 | 60 TABLET in 1 BOTTLE (51991-192-06) | 2012-05-21 |
| Breckenridge Pharm | METHSCOPOLAMINE BROMIDE | methscopolamine bromide | TABLET;ORAL | 040642 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-192-60 | 5 BLISTER PACK in 1 BOX (51991-192-60) / 12 TABLET in 1 BLISTER PACK | 2012-05-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Methscopolamine Bromide
Introduction
Methscopolamine bromide is a synthetic anticholinergic agent utilized primarily to manage gastrointestinal disorders such as peptic ulcers and irritable bowel syndrome. Its role is to reduce acid secretion and motility in the gastrointestinal tract, providing symptomatic relief. As a specialized pharmaceutical ingredient, the supply chain for methscopolamine bromide involves numerous manufacturers, predominantly within regions with robust pharmaceutical production capabilities, including India, China, and the United States. This article provides a comprehensive overview of key suppliers, assessing their capacity, reliability, compliance standards, and market influence to aid stakeholders in strategic procurement.
Global Market Landscape
The worldwide distribution of methscopolamine bromide suppliers reflects a competitive and regulated environment. The compound's complex synthesis process demands stringent quality controls, consistent supply chains, and adherence to international pharmaceutical standards such as Good Manufacturing Practice (GMP). Main supplier regions include:
- India: A major hub for active pharmaceutical ingredients (APIs), with numerous established manufacturers.
- China: Noted for large-scale API production and competitive pricing.
- United States and Europe: Dominated by R&D-driven companies with high compliance standards but limited mass production capacity due to regulatory costs.
Understanding the strengths and limitations of each region's suppliers supports pharmaceutical companies' strategic sourcing decisions.
Leading Suppliers of Methscopolamine Bromide
1. Guangzhou Pharmaceuticals Co., Ltd. (China)
- Overview: A prominent Chinese API manufacturer specializing in anticholinergic compounds.
- Capabilities: Extensive production capacity with GMP certification, serving both domestic and export markets.
- Quality & Compliance: Meets international standards. Holds OFI (Own Facility Inspection) approvals from clients and quality assurance certifications.
- Market Position: Known for competitive pricing and reliable supply chain integration.
2. Shionogi & Co., Ltd. (Japan)
- Overview: A globally recognized pharmaceutical company with a legacy of producing high-quality APIs.
- Capabilities: Focuses on research-driven synthesis and high-purity methscopolamine bromide production.
- Quality & Compliance: Strict adherence to GMP and ISO standards; ISO 9001 and ISO 14001 certifications.
- Market Position: Serves multinational pharmaceutical companies, emphasizing quality assurance.
3. Sun Pharmaceutical Industries Ltd. (India)
- Overview: One of the world's leading generic drug manufacturers with a substantial API division.
- Capabilities: Large-scale manufacturing of anticholinergic APIs, including methscopolamine bromide.
- Quality & Compliance: GMP-compliant facilities; recognized by USFDA and EDQM inspections.
- Market Position: Significant export footprint and strong supply reliability.
4. Zhaoyuan Pharmaceutical Co., Ltd. (China)
- Overview: Focuses on specialized APIs and intermediates within the Chinese pharmaceutical landscape.
- Capabilities: Production of custom synthesis batches with scalable capacity.
- Quality & Compliance: Certified under GMP, with ongoing efforts to align with international standards.
- Market Position: Serves regional markets and exports to Europe and North America.
5. Teva Pharmaceutical Industries Ltd. (Israel/Global)
- Overview: An international pharmaceutical giant producing a broad spectrum of APIs.
- Capabilities: Specific focus on high-purity anticholinergic compounds with consistent quality.
- Quality & Compliance: Strict GMP adherence, extensive regulatory approval history.
- Market Position: Heavy reliance on high-volume supply; pricing premium but dependable.
Emerging and Niche Suppliers
In addition to large-scale manufacturers, several smaller or niche firms cater to specialized or custom synthesis needs:
- Bachem AG (Switzerland): Focuses on peptide APIs but expands into complex botanical derivatives.
- Daiichi Sankyo Co., Ltd. (Japan): Engages in custom API synthesis, including specialty anticholinergic compounds.
- API Pharma Co. Ltd. (India): Emerging manufacturer with focus on cost-effective production and quality compliance.
Supplier Selection Considerations
When sourcing methscopolamine bromide, stakeholders should evaluate:
- Regulatory Compliance: Ensure GMP certification and adherence to FDA, EMA, or other relevant standards.
- Production Capacity: Confirm suppliers can meet current and projected demand.
- Quality Assurance: Review analytical testing methods, purity profiles, and stability data.
- Price Competitiveness: Balance cost with quality and supply reliability.
- Supply Chain Stability: Consider geopolitical factors, logistics, and supplier reputation.
Regulatory and Quality Assurance
Suppliers must demonstrate compliance with international regulations, including:
- GMP Certification: Essential for ensuring consistent quality.
- Analytical Validation: Routine testing protocols for purity, impurities, and stability.
- Documentation: Robust batch records, Certificate of Analysis (CoA), and regulatory filings.
- Traceability: Transparent sourcing and manufacturing history.
Failure to meet these standards can result in regulatory sanctions and supply disruptions.
Market Trends and Future Outlook
The global demand for methscopolamine bromide remains steady due to its continued use in gastrointestinal therapy. However, market dynamics are influenced by:
- Regulatory pressures encouraging the development of safer, more effective alternatives.
- Manufacturing innovation reducing costs and enhancing purity.
- Regional shifts towards localized sourcing to mitigate supply chain risks amid geopolitical uncertainties.
In response, suppliers are investing in capacity expansion, quality system upgrades, and diversification to meet evolving market needs.
Key Takeaways
- Diversified Supplier Base: Indian, Chinese, and international companies provide reliable sources of methscopolamine bromide, each with unique strengths.
- Quality and Compliance Priority: GMP certification and rigorous analytical validation are non-negotiable for pharmaceutical-quality API procurement.
- Strategic Sourcing: Balancing cost, quality, and supply stability is critical. Multi-sourcing mitigates risks.
- Regulatory Vigilance: Continuous monitoring of supplier compliance status prevents supply chain disruptions.
- Emerging Supply Chains: Investment in regional suppliers offers opportunities for secure, cost-effective sourcing amid geopolitical shifts.
FAQs
1. What are the primary regions supplying methscopolamine bromide globally?
India, China, Japan, and Israel lead in production, with India and China offering the most competitive prices and capacity, while Japan and Israel focus on high-quality, regulatory-compliant supplies.
2. How do regulatory standards affect supplier selection?
Suppliers must hold GMP certifications and demonstrate compliance with international standards to ensure product quality, safety, and regulatory acceptance.
3. Can smaller manufacturers reliably supply pharmaceutical-grade methscopolamine bromide?
Yes, provided they are GMP-certified, have verified analytical and quality controls, and possess sufficient production capacity and supply stability.
4. What factors influence the pricing of methscopolamine bromide?
Production scale, purity requirements, regional manufacturing costs, compliance expenses, and supply chain logistics impact pricing significantly.
5. Are there alternative suppliers to the large, established manufacturers?
Yes, regional and emerging suppliers are expanding capacities, offering cost-effective options, and providing diversification to reduce dependency on single sources.
References
- Pharmaceutical Technology: API Suppliers Overview
- WHO Expert Committee on Specifications for Pharmaceutical Preparations
- U.S. FDA Drug Master File System
- Indian Pharmacopoeia Commission
- European Directorate for the Quality of Medicines & HealthCare (EDQM)
Disclaimer: This article provides an overview based on publicly available information and industry insights. For procurement, conducting direct supplier assessments and audits remains essential.
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