Bulk Pharmaceutical API Sources for OXYPHENONIUM BROMIDE

Bulk Pharmaceutical API Sources for OXYPHENONIUM BROMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246887
NovoSeek		5748
MP Biomedicals		156027
MolPort		MolPort-000-735-345

Bulk Active Pharmaceutical Ingredient (API) Sources for: Oxyphenonium Bromide

Last updated: August 5, 2025

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Introduction

Oxyphenonium bromide, a quaternary ammonium compound with antispasmodic properties, serves primarily in gastrointestinal treatments. As a vital API, its sourcing critically influences pharmaceutical manufacturing, regulatory compliance, and supply chain stability. This analysis details the global landscape of bulk API suppliers for oxyphenonium bromide, emphasizing key manufacturers, geographic distribution, quality standards, and market trends.

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Overview of Oxyphenonium Bromide

Initially developed in the mid-20th century, oxyphenonium bromide functions by antagonizing parasympathetic nerve impulses in smooth muscle tissues. Its therapeutic indications include relief from irritable bowel syndrome, cramping, and other gastrointestinal motility disorders ([1]). The API’s pharmacological profile and manufacturing complexities render reliable sourcing essential for pharmaceutical companies.

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Global API Manufacturing Landscape

Manufacturers and Suppliers

1. Chinese API Producers

The majority of oxyphenonium bromide APIs originate from China, home to several large-scale contract manufacturing organizations (CMOs) and chemical synthesis facilities. Critical players include:

• Shandong Lanhai Pharmaceutical Co., Ltd. — Offers competitive pricing with established expertise in quaternary ammonium compounds.
• Henan Tianfu Chemical Co., Ltd. — Specializes in gastrointestinal pharmaceutical intermediates with GMP-certified facilities.
• Qingdao Seawin Biotech Group Co., Ltd. — Supplies high-quality APIs to global markets, adhering to stringent quality standards.

Chinese suppliers are prominent due to their manufacturing capacity, cost efficiency, and technological advancements in chemical synthesis.

2. Indian API Manufacturers

India is a notable player in the API manufacturing sector, providing a mix of bulk APIs for global export. Major manufacturers include:

• Gulam Rasool & Brothers Chemists Ltd. — Known for producing specialty APIs including oxyphenonium bromide, with adherence to WHO-GMP standards.
• Suyog Organics Ltd. — Focuses on custom synthesis and contract manufacturing, emphasizing quality control.

3. European and North American Suppliers

While relatively fewer in number, some European and North American APIs are imported for high-quality applications, often as finished APIs exported from Asian manufacturing units. Companies like BASF and Evonik may also be involved in the synthesis or supply of intermediates, albeit in limited quantities.

Types of Suppliers

• Contract Manufacturing Organizations (CMOs): Offer custom synthesis capabilities, often producing APIs to meet specific regulatory standards.
• Established API Producers: Larger firms with extensive production facilities, quality management systems, and validated processes.
• Trading Companies and Distributors: Facilitate bulk procurement and logistics, especially for smaller pharmaceutical firms.

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Quality Standards and Regulatory Compliance

Quality assurance is pivotal for oxyphenonium bromide APIs, with suppliers typically compliant with:

• Current Good Manufacturing Practices (cGMP): Essential for pharmaceutical-grade APIs, ensuring consistent quality and purity.
• Pharmacopoeial Standards: British Pharmacopoeia (BP), United States Pharmacopeia (USP), or European Pharmacopoeia (EP) specifications guide acceptable impurity profiles, assay limits, and stability criteria.

Suppliers often provide Certificates of Analysis (CoA) and Good Manufacturing Practice (GMP) certifications, essential for regulatory submissions.

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Market Trends and Supply Chain Considerations

• Supply Chain Disruptions: The COVID-19 pandemic accentuated vulnerabilities in the global API supply chain, prompting pharmaceutical companies to diversify sourcing, particularly from China and India.

• Regulatory Scrutiny: Increasing demands for transparency and compliance have led to tighter regulations, especially in North America and Europe, impacting sourcing strategies.

• Price Competition: Market competitiveness is fierce among Asian suppliers, driving pricing dynamics while maintaining quality standards.

• Environmental and Sustainability Initiatives: Suppliers adopting greener synthesis pathways and reducing hazardous waste are gaining favor, aligning with global environmental standards.

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Supplier Selection Criteria

When sourcing oxyphenonium bromide API, stakeholders should prioritize:

• Regulatory Compliance: GMP certification, pharmacopoeial compliance, and audit readiness.
• Quality and Purity: High assay purity (>99%) and low impurity levels.
• Production Capacity: Ability to meet forecasted demand without supply gaps.
• Pricing and Lead Time: Competitive pricing aligned with quality standards.
• Supply Chain Stability: Proven track record of consistent delivery and logistical robustness.

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Emerging Opportunities for API Sourcing

Innovations in synthetic chemistry, such as green chemistry approaches and continuous manufacturing, are being adopted by leading suppliers. These developments enhance process efficiency, reduce environmental impact, and improve API quality.

Furthermore, regional manufacturing hubs in Southeast Asia are emerging, offering new sourcing options amid geopolitical and trade tensions influencing traditional supplier bases.

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Conclusion

The primary bulk sources of oxyphenonium bromide API are concentrated within China and India, supported by a growing presence of European quality-centric manufacturers. Ensuring supply chain robustness requires diligent supplier vetting based on regulatory compliance, quality standards, and capacity. As the pharmaceutical industry evolves, sourcing strategies must adapt, emphasizing sustainability, regulatory adherence, and diversification to secure reliable API supply.

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Key Takeaways

• The Chinese API manufacturing sector dominates oxyphenonium bromide supply due to capacity and cost advantages, but regulatory vigilance is necessary.
• Indian and European suppliers provide alternative sourcing options, often with a focus on high-quality, GMP-compliant APIs.
• Supply chain resilience has become more critical post-pandemic, prompting diversification and strategic sourcing.
• Regulatory compliance and consistent quality remain the cornerstone criteria for choosing API suppliers.
• Advances in sustainable manufacturing processes offer new avenues for sourcing high-quality APIs with reduced environmental impact.

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FAQs

1. What are the main considerations when sourcing oxyphenonium bromide APIs?
Prioritize GMP certification, regulatory compliance, purity levels, supplier capacity, and logistical reliability.

2. Are there regional differences in API quality standards for oxyphenonium bromide?
Yes. Suppliers adhering to stringent regional standards like USP, EP, or BP typically ensure higher consistency and regulatory acceptance.

3. How has the COVID-19 pandemic affected oxyphenonium bromide API supply chains?
It exposed vulnerabilities, prompting increased emphasis on supplier diversification and stockpiling within supply chains.

4. Can I source oxyphenonium bromide APIs from small-scale manufacturers?
While possible, smaller manufacturers may lack the extensive quality controls required for pharmaceutical-grade APIs; thorough vetting is essential.

5. What emerging trends may influence future oxyphenonium bromide API sourcing?
Green chemistry, continuous manufacturing, and regional supply hubs are shaping future sourcing strategies, emphasizing sustainability and resilience.

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References

[1] Clinical Pharmacology & Therapeutics, "Oxyphenonium Bromide: Pharmacology and Therapeutic Applications," 2021.