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Suppliers and packagers for generic pharmaceutical drug: BETHANECHOL CHLORIDE
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BETHANECHOL CHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharm | BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-571-01 | 100 TABLET in 1 BOTTLE (53746-571-01) | 2022-04-15 |
| Amneal Pharm | BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-572-01 | 100 TABLET in 1 BOTTLE (53746-572-01) | 2022-04-15 |
| Amneal Pharm | BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-573-01 | 100 TABLET in 1 BOTTLE (53746-573-01) | 2022-04-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Bethanechol Chloride
Introduction
Bethanechol chloride is a cholinergic agonist primarily used to stimulate bladder and gastrointestinal motility in cases of postoperative or neurogenic urinary retention and gastric atony. As a critical therapeutic agent, its quality, availability, and supplier reliability are pivotal for healthcare providers. A comprehensive understanding of the leading suppliers of bethanechol chloride is essential for pharmaceutical companies, distributors, and healthcare institutions aiming for consistent supply chains and regulatory compliance.
Market Overview of Bethanechol Chloride
Bethanechol chloride is a synthetic compound that mimics acetylcholine, selectively stimulating muscarinic receptors. It is primarily available in oral tablet formulations and as an injectable. The drug's production demands adherence to stringent Good Manufacturing Practice (GMP) standards, with suppliers often located in key manufacturing hubs across Europe, Asia, and North America.
The global demand for bethanechol chloride remains relatively stable, driven by its indication in urology and gastroenterology. The competitive landscape comprises several established pharmaceutical excipients and active pharmaceutical ingredient (API) manufacturers, alongside generic drug producers.
Major Suppliers of Bethanechol Chloride
1. Teva Pharmaceutical Industries Ltd.
Overview:
Teva, headquartered in Israel, is among the world's largest producers of generic pharmaceuticals. The company offers a broad portfolio, including chemical APIs like bethanechol chloride. Known for its extensive manufacturing and distribution network, Teva maintains high-quality standards aligned with international regulatory agencies.
Supply Capabilities:
Teva's production facilities in Europe and North America are GMP-certified, ensuring a reliable supply for global markets. Their API manufacturing facilities are equipped with advanced process control systems, facilitating consistent batch quality.
Regulatory Status:
Bethanechol chloride supplied by Teva is approved in multiple regions, including the US (FDA-approved), European Union (EMA-compliant), and other jurisdictions. Their compliance with regulatory standards makes them a trusted supplier.
2. Sun Pharmaceutical Industries Ltd.
Overview:
An Indian multinational, Sun Pharma is among the world's largest generics companies, with a significant presence in API manufacturing, including bethanechol chloride. Their global operations include manufacturing sites in India, the US, and Europe.
Supply Capabilities:
Sun Pharma's manufacturing facilities comply with international GMP standards. They provide both bulk API and finished dosage forms, with a focus on cost-effective production without compromising quality.
Market Reach:
The company's extensive distribution channels enable broad availability of bethanechol chloride in North America, Europe, and emerging markets.
3. Xian Janssen Pharmaceutical (a subsidiary of Johnson & Johnson)
Overview:
Xian Janssen is a leading Chinese API manufacturer with a solid reputation for producing high-quality specialty chemicals, including bethanechol chloride. Their offerings are primarily supplied within China and exported globally.
Supply Capabilities:
Xian Janssen's manufacturing process adheres to strict GMP standards, and their products are compliant with international pharmacopoeia specifications.
Regulatory Approvals:
Their APIs often serve as components in finished pharmaceutical products approved under international regulatory bodies, enhancing trust in their supply chain reliability.
4. Wuhan Pharmaceutical Group
Overview:
Located in China, Wuhan Pharmaceutical Group specializes in the manufacture of cholinergic agents and related compounds. They are a significant regional supplier of bethanechol chloride for domestic and export markets.
Supply Capabilities:
Their manufacturing processes follow GMP guidelines, and they offer competitive pricing attractive to generic pharmaceutical producers.
Regulatory Status:
While primarily serving Asian markets, they have worked toward increasing their regulatory certifications to serve Western markets.
5. Hetero Labs Limited
Overview:
Hetero, based in India, is renowned for its API manufacturing expertise, including the production of cholinergic agents like bethanechol chloride. Their product quality is validated through international regulatory compliance.
Supply Capabilities:
Hetero's global export capacity includes key regions such as the US, Europe, and South America, supported by multiple GMP-certified manufacturing plants.
Emerging Suppliers and OEMs
Beyond these established players, several smaller and emerging suppliers are increasingly contributing to the bethanechol chloride market, mainly via outsourcing manufacturing through contract manufacturing organizations (CMOs). These partners often provide customized formulations and support regulatory filings.
Supply Chain Considerations
- Regulatory Compliance: Suppliers must demonstrate compliance with GMP, pharmacopeial standards (USP, EP, JP), and relevant regional regulations.
- Quality Assurance: Consistent batch-to-batch quality, validated processes, and stability data are critical.
- Capacity and Scalability: Ensuring suppliers can meet fluctuating demands is vital, especially during supply disruptions.
- Price and Cost Efficiency: Competitive pricing from suppliers in India and China often influences procurement decisions, balanced against quality and regulatory reliability.
- Intellectual Property: While bethanechol chloride is a generic drug, sourcing from suppliers compliant with licensing agreements ensures legal supply.
Conclusion
Selecting the appropriate supplier for bethanechol chloride involves balancing quality, regulatory compliance, capacity, and cost. Leading manufacturers like Teva, Sun Pharma, Xian Janssen, Wuhan Pharmaceutical, and Hetero Labs dominate the market, supported by their GMP certifications and global distribution networks. Healthcare providers and pharmaceutical companies must conduct due diligence, verifying regulatory approvals, quality certifications, and supply stability before establishing procurement agreements.
Key Takeaways
- Market Leaders: Teva and Sun Pharma are the dominant global suppliers of bethanechol chloride, offering reliable, GMP-compliant APIs.
- Regulatory Adherence: Suppliers with international certifications (FDA, EMA, JP, USP) ensure compliance and mitigate regulatory risks.
- Quality and Capacity: Prioritize suppliers with robust quality assurance systems and scalable manufacturing capacity.
- Regional Considerations: Geographic location affects lead times, costs, and import/export regulations; China and India are primary manufacturing hubs.
- Supply Chain Resilience: Diversify suppliers to reduce risk associated with geopolitical tensions, manufacturing disruptions, or regulatory changes.
FAQs
1. What factors influence the choice of supplier for bethanechol chloride?
Key factors include regulatory compliance, product quality, manufacturing capacity, delivery reliability, price competitiveness, and the supplier's reputation within the pharmaceutical industry.
2. Are there generic alternatives to brand-name bethanechol chloride?
Yes. Generic versions are widely available from multiple suppliers, typically at lower costs, provided they meet regulatory standards and quality benchmarks.
3. How does regulatory compliance impact supplier selection?
Regulatory compliance ensures the API meets pharmacopeial standards and quality norms, reducing the risk of product recalls, regulatory sanctions, and supply chain disruptions.
4. Which regions dominate bethanechol chloride manufacturing?
India and China are primary manufacturing hubs due to cost advantages and extensive API production infrastructure. Europe and North America also host key GMP-certified suppliers.
5. What are the key risks associated with sourcing bethanechol chloride?
Risks include supply shortages, regulatory non-compliance, quality variability, geopolitical issues, and logistical delays. Mitigation strategies involve supplier qualification, diversification, and rigorous quality audits.
References
[1] U.S. Food and Drug Administration (FDA). Bioequivalence and other data required for generic drug applications.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
[3] Indian Pharmaceutical Alliance. API manufacturing standards and market overview.
[4] Johnson & Johnson. API production capabilities and regulatory compliance.
[5] Market analysis reports on the global API industry, 2022.
Disclaimer: The information provided is for industry analysis purposes only and does not constitute endorsement or supplier recommendations.
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