Bulk Pharmaceutical API Sources for pentolinium tartrate

Bulk Pharmaceutical API Sources for pentolinium tartrate

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		YjRTC@BBo`DBFAIECG@dliNrxj_irJZZZ@jZZZ@rQIUIJQJY[DejjYjjZjjjjjhcAhkGr@@
NovoSeek		5849
NovoSeek		5702277
AAA Chemistry		AR-1J3612
ABI Chem		AC1L1L9Q
ABI Chem		AC1NWAY7

Bulk Active Pharmaceutical Ingredient (API) Sources for: PENTOLINIUM TARTRATE

Last updated: August 14, 2025

Introduction

Pentolinium tartrate, a potent muscarinic receptor antagonist, plays a critical role in ophthalmology and diagnostic procedures by inducing miosis. Its high efficacy as an anticholinergic agent necessitates sourcing high-quality bulk APIs to ensure safety, efficacy, and regulatory compliance. With rising global demand, identifying reliable suppliers for pentolinium tartrate has become essential for pharmaceutical manufacturers, compounding pharmacies, and research institutions.

This analysis examines the current landscape of suppliers offering bulk pentolinium tartrate API, evaluates their credibility, manufacturing standards, regulatory status, and geographic distribution, providing vital insights for procurement strategies.

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Overview of Pentolinium Tartrate

Pentolinium tartrate is primarily used in ophthalmic solutions to facilitate medical examinations and surgeries requiring pupil constriction. Its pharmaceutical formulation demands APIs with high purity (>99%) and compliance with Good Manufacturing Practice (GMP) standards.

The synthesis of pentolinium tartrate involves complex organic chemistry, highlighting the importance of sourcing from reputable manufacturers with rigorous quality controls. Ensuring consistent supply and adherence to international standards is fundamental for pharmaceutical integrity.

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Global API Suppliers for Pentolinium Tartrate

1. Major Manufacturers and Distributors

a. Sigma-Aldrich (Merck Group)
Sigma-Aldrich, a subsidiary of Merck KGaA, provides a comprehensive catalog of research-grade APIs, including pentolinium tartrate. Though primarily catering to research and development, their APIs often meet high purity standards suitable for clinical trials and initial formulation testing.

• Advantages: Established global reputation, high purity standards, extensive regulatory documentation.
• Limitations: Usually limited to research-grade material; bulk pharmaceutical manufacturing is less common.

b. Thermo Fisher Scientific
Known for supplying a broad range of specialty chemicals and APIs, Thermo Fisher’s offerings include compounds suitable for pharmaceutical development. While detailed listings of pentolinium tartrate are rare, custom synthesis and sourcing are available on request.

• Advantages: Custom synthesis capabilities, rigorous quality assurance.
• Limitations: Potential lead time for procurement, variable pricing.

c. Tocris Bioscience (Bio-Techne)
Specializing in research compounds, Tocris provides high-grade chemicals, including some pharmacological agents used for research. They may supply pentolinium tartrate for experimental or non-GMP applications.

• Advantages: Reliable quality control, worldwide distribution.
• Limitations: Not targeted for large-scale pharmaceutical manufacturing.

2. Contract Manufacturing Organizations (CMOs) and API Manufacturers

a. Hubei Huahong Pharmaceutical Co., Ltd. (China)
A prominent Chinese API manufacturer with capabilities to produce specialized compounds, including muscarinic antagonists, under GMP standards. Their production facilities are certified by international regulatory bodies, making them suitable suppliers for pharmaceutical companies seeking large-scale API procurement.

• Advantages: Competitive pricing, scalable capacity, compliance with GMP.
• Limitations: Language barriers, geographic distance, and varying quality documentation standards may necessitate thorough audits.

b. Sinopharm Chemical Reagents Co., Ltd. (China)
This company supplies raw pharmaceutical ingredients, including specialty APIs like pentolinium tartrate, to global markets. They claim adherence to quality standards aligned with international regulatory requirements.

• Advantages: Cost-effective, flexible sampling, and production volumes.
• Limitations: Need for rigorous vendor qualification to ensure compliance and purity.

c. Sandoz (Novartis Division)
Sandoz is a leading global producer of generic APIs and formulations, with extensive GMP-certified facilities. While their primary portfolio includes widely-used APIs, they also engage in the development of specialized compounds, and potential custom synthesis of pentolinium tartrate exists based on client specifications.

• Advantages: Global distribution network, stringent quality oversight.
• Limitations: High minimum order quantities, complex contracting process.

3. Regional and Niche API Suppliers

a. EuroAPI (France)
EuroAPI specializes in high-quality APIs with a focus on transparency and regulatory compliance. They serve clients across Europe and North America, providing APIs suitable for clinical and commercial applications.

• Advantages: Robust quality systems, flexible supply options.
• Limitations: Potential lead times depending on stock levels.

b. Wuxi AppTec (China)
A notable contract research and manufacturing organization, Wuxi AppTec offers API development, custom synthesis, and manufacturing. Their capabilities include producing complex compounds like pentolinium tartrate, with assurance of regulatory compliance.

• Advantages: Integrated R&D-to-production services, global reach.
• Limitations: Variability in pricing and lead times.

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Considerations for API Sourcing

Quality Assurance and Regulatory Compliance
Secure suppliers with documented GMP certifications, validated analytical methods, and comprehensive batch documentation. This mitigates risks associated with impurity profiles and cross-border shipping regulatory hurdles.

Purity and Specifications
Demand detailed Certificates of Analysis (CoA) emphasizing high purity (>99%), low impurities, and appropriate physicochemical parameters consistent with pharmacopeial standards.

Supply Security and Scalability
Establish relationships with multiple suppliers across regions to diversify risk, ensure continuous supply, and fulfill scaling needs from clinical trials to commercial production.

Pricing and Lead Times
Assess total cost of procurement, including shipping, customs, and import duties, alongside lead times. Consider long-term agreements for priority access amid market fluctuations.

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Emerging Trends and Future Outlook

The API market for niche compounds like pentolinium tartrate remains dynamic. Increasing regulatory scrutiny and quality standards push suppliers toward transparency and technological upgrades. The rise of contract manufacturing in China and India offers cost advantages, but buyers must exercise rigorous verification procedures.

Advances in synthetic methodologies and process intensification potentially enable more efficient production, reducing costs and environmental impact. Regulatory harmonization efforts, notably ICH guidelines, further streamline cross-border sourcing.

In summary, the global API landscape offers multiple sourcing options that necessitate careful evaluation of quality, compliance, cost, and geopolitical stability. Strategic supplier relationships are crucial for maintaining an uninterrupted supply chain, especially given pentolinium tartrate's specialized application scope.

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Key Takeaways

• Reputable suppliers of pentolinium tartrate include established global API manufacturers, research chemical providers, and Chinese CMOs, each with specific advantages and limitations.

• Prioritize vendors with GMP certification, detailed Certificates of Analysis, and proven regulatory compliance to ensure API quality and safety.

• Diversify supply sources geographically to mitigate risks associated with geopolitical, logistical, or regulatory disruptions.

• Engage in long-term supplier relationships aligned with regulatory trends to facilitate scalable procurement and regulatory filings.

• Continually monitor market developments, synthetic process innovations, and regulatory updates affecting API sourcing strategies for pentolinium tartrate.

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FAQs

1. What are the critical quality parameters for bulk pentolinium tartrate APIs?
High purity (>99%), low impurity levels, consistent batch-to-batch quality, and certification of GMP compliance are essential.

2. Are there regional differences in sourcing pentolinium tartrate?
Yes, suppliers from North America, Europe, and China dominate the market. Chinese manufacturers often provide cost-effective options but may require thorough quality audits.

3. Can pentolinium tartrate APIs be custom synthesized?
Yes, many contract manufacturers offer custom synthesis tailored to specific purity, quantity, and formulation needs.

4. What regulatory considerations should I be aware of when sourcing APIs internationally?
Ensure suppliers comply with local and international GMP standards, provide comprehensive documentation, and adhere to import/export regulations for pharmaceuticals.

5. How does market demand influence API availability?
Demand fluctuations impact supply stability; establishing relationships with multiple suppliers and maintaining strategic inventory buffers mitigate risks.

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References

[1] Pharmaceutical Supply Chain and API Sourcing Strategies. Pharma Intelligence.
[2] International Conference on Harmonisation (ICH) Guidelines. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[3] Sigma-Aldrich Product Catalog. Merck KGaA.
[4] Contract Manufacturing Capabilities of Wuxi AppTec. Wuxi AppTec Official Website.
[5] Regulatory Standards for API Manufacturing. U.S. FDA Guidance.