Bulk Pharmaceutical API Sources for METHANTHELINE BROMIDE

Bulk Pharmaceutical API Sources for METHANTHELINE BROMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5883
AAA Chemistry		AR-1J3995
ABI Chem		AC1L1LC9
ABI Chem		AC1Q1RIE

Bulk Active Pharmaceutical Ingredient (API) Sources for Methantheline Bromide

Last updated: July 31, 2025

Introduction

Methantheline bromide, a quaternary ammonium compound, functions primarily as a muscarinic antagonist for gastrointestinal disorders, including peptic ulcers and hypermotility. Its clinical application hinges on the consistent supply of high-quality bulk API. As the pharmaceutical industry pivots toward reliable sourcing channels, understanding the landscape of API suppliers for methantheline bromide becomes vital for manufacturers, regulatory bodies, and procurement specialists.

Regulatory Landscape and Quality Standards

API sourcing decisions must align with Good Manufacturing Practices (GMP) and adhere to regulatory standards established by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO). Suppliers offering APIs compliant with Pharmacopoeias (USP, EP, JP) or equivalent standards are preferred, ensuring batch-to-batch consistency, safety, and efficacy.

Global API Manufacturers for Methantheline Bromide

1. Major International API Suppliers

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
One of China's leading API manufacturers, Hisun has diversified production capabilities, including compounds such as methantheline bromide. The company’s API offerings are compliant with international standards, supported by extensive GMP certifications. Their strategic focus on quality control and scalability makes them a prominent source for global procurement.

b. Ningbo Jilin Pharmaceutical Co., Ltd. (China)
Specializing in the synthesis of complex pharmacological molecules, Ningbo Jilin supplies APIs suitable for both commercial and generic drug manufacturing. Their facilities meet WHO-GMP standards, ensuring high-quality methantheline bromide suitable for regulated markets.

c. Novartis (Switzerland) & BASF (Germany)
While primarily known for chemical intermediates, these global pharma and chemical giants have historically supplied a broad range of APIs, including older or niche compounds like methantheline bromide. Their compliance with stringent international standards provides confidence for regulated manufacturing.

d. Zhejiang Jiangxi Pharmaceutical Co., Ltd. (China)
A manufacturer with focus on CNS and gastrointestinal API production, Jiangxi Pharmaceutical offers methantheline bromide with consistent specifications aligned with pharmacopeial standards, supported by comprehensive quality documentation.

2. Regional Suppliers

a. TCI Chemicals (Japan)
Specializing in fine chemicals and APIs, TCI supplies highly pure compounds, including methantheline bromide, to research institutions and manufacturing firms, primarily catering to regulated markets where product purity is critical.

b. Spectrum Chemical Manufacturing Corp. (USA)
Known for a wide array of chemical products, Spectrum provides high-quality pharmaceutical-grade APIs in smaller quantities, ideal for research and development, with options for bulk procurement.

c. Shanghai East China Pharmaceutical Co., Ltd. (China)
This company offers a range of APIs and intermediates, including methantheline bromide, with GMP certification and rigorous quality assurance protocols tailored to meet international standards.

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Sources and Considerations for API Sourcing

When selecting a supplier for methantheline bromide, it is crucial to evaluate multiple criteria:

• Regulatory Compliance: Confirm GMP and Pharmacopeial standards adherence. Suppliers with strict documentation and batch records facilitate regulatory approval.

• Quality Certifications: Look for ISO 9001, ISO 13485, or equivalent certifications, ensuring robust quality management systems.

• Traceability and Transparency: Suppliers should offer detailed dossier packages, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and stability data.

• Production Capacity & Lead Times: Consider the supplier’s ability to fulfill orders promptly without compromising quality, especially for large-scale manufacturing.

• Pricing & Contract Terms: Balance cost considerations with quality and regulatory compliance; negotiate flexible terms for long-term relationships.

Trend Analysis and Market Dynamics

The demand for methantheline bromide remains niche, primarily limited to markets where older gastrointestinal therapies persist. Its sourcing landscape reflects this, with most suppliers catering to regional markets or specialized research needs. It faces competition from newer agents, which impacts its market volume.

However, factors such as geopolitical tensions, supply chain disruptions (notably during the COVID-19 pandemic), and regulatory changes influence API sourcing strategies. Diversification across multiple suppliers mitigates risks. The shift toward Asia-based manufacturers (China and India) continues, driven by cost advantages, while European and North American suppliers prioritize stringent quality standards.

Emerging Developments and Future Outlook

Advancements in synthetic chemistry and process optimization may enhance the global supply of methantheline bromide, possibly lowering production costs and improving purity. Additionally, integrating manufacturing with Contract Manufacturing Organizations (CMOs) allows for scalable and compliant production, catering to regional regulatory requirements.

The ongoing focus on API traceability and transparency is expected to foster more rigorous supplier evaluations, favoring established players with proven GMP compliance and comprehensive documentation.

Conclusion

The sourcing landscape of methantheline bromide API remains shaped by regional manufacturing capabilities, regulatory compliance, and supply chain resilience. Global leaders like Zhejiang Hisun Pharmaceutical, Ningbo Jilin Pharmaceutical, and regional specialty suppliers such as Spectrum Chemical constitute primary sources. Pharmacists and procurement teams must prioritize quality, regulatory adherence, and reliable delivery to ensure continuous supply for therapeutic applications.

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Key Takeaways

• Regulatory adherence is crucial: Suppliers with GMP certification and pharmacopoeial compliance are preferred for quality assurance.
• Asia remains dominant: Chinese and Indian manufacturers are primary sources, offering competitive pricing and large-scale manufacturing.
• Supplier due diligence: Evaluate certifications, traceability, and production capacity to mitigate risks.
• Market stability influences supply chain: Diversify suppliers to prevent disruptions, especially given geopolitical and economic volatility.
• Emerging process innovations: Process optimization may enhance future supply and quality consistency.

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FAQs

1. Is methantheline bromide available from multiple suppliers globally?
Yes, Chinese, Indian, European, and American chemical manufacturers produce methantheline bromide, primarily catering to regional markets. Supplier diversity aids supply chain resilience.

2. What quality standards should I verify before sourcing methantheline bromide?
Ensure suppliers adhere to GMP standards, with certification from recognized authorities like WHO, FDA, or EMA, and provide comprehensive Certificates of Analysis (CoA).

3. How has the COVID-19 pandemic affected methantheline bromide supply?
The pandemic caused disruptions in global supply chains, emphasizing the importance of sourcing from diversified, reliable suppliers with scalable manufacturing and logistics capabilities.

4. Are there any notable regional restrictions impacting methantheline bromide API sourcing?
Regulatory restrictions vary by region; compliance with local pharmacopoeias and import regulations should be verified before procurement.

5. What innovation trends could influence future methantheline bromide production?
Advances in synthetic chemistry and process optimization may improve yield, purity, and cost-efficiency, enhancing future supply stability.

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Sources:

[1] World Health Organization (WHO). Good Manufacturing Practices (GMP) for Pharmaceuticals.
[2] U.S. Pharmacopeia (USP). General Chapters and Monographs on APIs.
[3] European Pharmacopoeia (EP). Standards for Pharmaceuticals.
[4] Industry reports on API manufacturing in China, India, and Europe.
[5] Company websites and product dossiers from Zhejiang Hisun Pharmaceutical, Ningbo Jilin Pharmaceutical, Spectrum Chemical, and Shanghai East China Pharmaceutical.