Bulk Pharmaceutical API Sources for PYRVINIUM PAMOATE

Bulk Pharmaceutical API Sources for PYRVINIUM PAMOATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-115-422
BOC Sciences		3546-41-6
Glentham Life Sciences Ltd.		GL7591

Bulk Active Pharmaceutical Ingredient (API) Sources for PYRVINIUM PAMOATE

Last updated: July 27, 2025

Introduction

Pyrvinium pamoate, a potent anthelmintic agent frequently utilized in treating parasitic infections, particularly filariasis and intestinal worms, stands out due to its unique pharmacological profile. As a component primarily used in pharmaceutical formulations, accessing high-quality bulk API sources for pyrvinium pamoate is critical for manufacturers, researchers, and healthcare providers. This article provides a comprehensive overview of the global suppliers, sourcing strategies, and critical considerations for acquiring pyrvinium pamoate API.

Overview of Pyrvinium Pamoate

Pyrvinium pamoate is a lipophilic, cationic compound belonging to the class of phenanthridinium derivatives. Its activity primarily stems from interference with mitochondrial electron transport in parasitic organisms, making it effective against a spectrum of helminthic infections. Its complex chemical nature necessitates specialized synthesis routes, which influences available sources of bulk API globally.

Global API Suppliers of Pyrvinium Pamoate

Identifying reputable sources of pyrvinium pamoate API demands meticulous evaluation of manufacturer credentials, regulatory compliance, and supply chain robustness. The following sections highlight key suppliers segmented by geographic regions.

1. Asian Manufacturers

a. China

China remains one of the dominant players in bulk pharmaceutical ingredients, including specialty APIs like pyrvinium pamoate. Several state-of-the-art pharmaceutical chemical producers operate GMP-certified facilities, catering to both domestic and international markets.

• Simcere Pharmaceutical Group: Known for developing niche APIs, including antiparasitic agents, with strict adherence to GMP standards.
• Shenzhen Beimu Biological Pharmaceutical Co., Ltd.: Specializes in phenanthridine derivatives and offers pyrvinium pamoate bulk API, subject to regulatory approval.

b. India

India’s pharmaceutical sector offers a range of APIs, often at competitive prices, with a focus on generic and specialty compounds.

• Hetero Labs Ltd.: Experienced in manufacturing antiparasitic APIs, potentially including pyrvinium pamoate for export markets—verification needed based on specific product listings.
• Biological E. Limited: Known for research in antiparasitics, may serve as a potential source, contingent on regulatory clearance.

2. European and North American Suppliers

While European and North American markets tend to focus more on finished formulations and novel therapeutics, certain specialized chemical suppliers provide pyrvinium pamoate API through established distributor networks.

• AlphaChem (UK): Offers custom synthesis and bulk procurement of phenanthridinium derivatives, with strict quality assurance protocols.
• Spectrum Chemical (USA): Provides research-grade quantities suitable for development and blinded trials; full GMP-grade API availability should be confirmed.
• Toronto Research Chemicals (Canada): Supplies a range of speciality pharmaceuticals and intermediates, including pyrvinium pamoate.

3. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

For pharmaceutical companies seeking to acquire pyrvinium pamoate in bulk, engaging with CDMOs can ensure quality and regulatory compliance.

• Evonik Industries and BASF: While primarily focused on bulk intermediates, they offer custom synthesis and scale-up services for phenanthridinium-based compounds.
• Fabre-Kramer Pharmaceuticals: Specializes in custom chemical synthesis with documented GMP processes, suitable for APIs like pyrvinium pamoate.

Regulatory and Quality Considerations

Ensuring API quality is paramount. Suppliers should possess current GMP certification, validated batch-to-batch consistency, and comprehensive analytical documentation (HPLC, NMR, MS). Regulatory approval status varies across jurisdictions; thus, registration with agencies such as the FDA or EMA enhances procurement confidence. Suppliers should also provide Certificates of Analysis (COA), stability data, and adherence to international standards.

Sourcing Strategies

• Direct Purchase from Manufacturers: Engaging directly with OEMs or CMOs provides better control over quality, pricing, and supply chain integrity.
• Authorized Distributors: Utilizing distributorship channels of established APIs ensures compliance, though often at a premium price point.
• Trade Shows and Industry Conferences: Events like CPhI Worldwide facilitate supplier vetting and strategic partnerships.
• Online Chemical Marketplaces: Platforms such as ChemSpore and Alibaba require cautious vetting to confirm supplier authenticity and GMP compliance.

Challenges in Sourcing Pyrvinium Pamoate API

• Limited Availability: Niche APIs like pyrvinium pamoate are less commonly available compared to mainstream APIs, often requiring custom synthesis.
• Regulatory Variability: Different jurisdictions have disparate approval pathways; international transfer of APIs mandates compliance with import/export regulations.
• Intellectual Property: While pyrvinium pamoate patent protections have largely expired, potential licensing or distribution rights may influence procurement options.

Conclusion

Sourcing pyrvinium pamoate API necessitates strategic engagement with reputable manufacturers or CROs, rigorous evaluation of quality standards, and adherence to regulatory frameworks. Asian suppliers, notably Chinese and Indian manufacturers, dominate the supply landscape, though European and North American suppliers can fulfill specialized or research-grade needs. Direct sourcing coupled with due diligence ensures procurement of high-quality API, vital for downstream pharmaceutical development and manufacturing.

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Key Takeaways

• Identify reputable suppliers with GMP certification, transparent analytical data, and regulatory compliance, especially in China and India.
• Engage with CMOs and custom synthesis providers for scalable and quality-assured API production.
• Prioritize quality assurance through Certificates of Analysis and regulatory documentation to mitigate risks.
• Consider geopolitical and regulatory factors impacting import/export of APIs across jurisdictions.
• Leverage industry events and online marketplaces cautiously, ensuring supplier verification and validation.

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FAQs

1. Is pyrvinium pamoate API readily available commercially?
While some suppliers stock pyrvinium pamoate API, its niche status often means it requires custom synthesis, making direct procurement less straightforward than mainstream APIs.

2. What should be verified before purchasing pyrvinium pamoate API?
Buyers should confirm GMP certification, detailed Certificates of Analysis, stability data, and compliance with relevant pharmacopeial standards.

3. Can pyrvinium pamoate API be sourced from over-the-counter chemical suppliers?
No; due to regulatory restrictions and quality concerns, sourcing should be through licensed pharmaceutical suppliers or authorized distributors.

4. Are there regional regulatory restrictions on importing pyrvinium pamoate API?
Yes; import/export regulations differ by country. It is essential to verify compliance with local regulatory agencies like the FDA or EMA.

5. What are the advantages of engaging with contract manufacturing organizations for pyrvinium pamoate?
CMOs can ensure scalable, consistent, and regulatory-compliant production, offering custom synthesis tailored to specific purity and quantity requirements.

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Sources:

[1] World Health Organization. (2020). Guidelines for the Treatment of Helminth Infections.
[2] Chinese Pharmacopoeia. (2020). Standards for phenanthridinium compounds.
[3] Indian Pharmacopoeia Commission. (2019). List of approved APIs and manufacturing standards.
[4] CPhI Pharma Insights. (2022). Global API Market Trends.
[5] U.S. Food & Drug Administration. (2023). Guidance for Industry – API Quality Standards.