Bulk Pharmaceutical API Sources for POLYETHYLENE GLYCOL 3350

Bulk Pharmaceutical API Sources for POLYETHYLENE GLYCOL 3350

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		qCa@CIKT@@
NovoSeek		174
Sigma-Aldrich		324558_SIAL
MP Biomedicals		151089

Bulk Active Pharmaceutical Ingredient (API) Sources for: POLYETHYLENE GLYCOL 3350

Last updated: July 29, 2025

Introduction

Polyethylene glycol 3350 (PEG 3350) is a widely used osmotic laxative primarily employed in over-the-counter (OTC) and prescription formulations for bowel cleansing and constipation relief. Its efficacy, safety, and versatility have led to substantial global demand, prompting a complex supply network of manufacturers and suppliers of the active pharmaceutical ingredient (API). This article examines the primary sources of bulk PEG 3350, routes of procurement, key manufacturers, regional supply dynamics, and factors influencing sourcing strategies for pharmaceutical and contract manufacturing organizations.

Overview of Polyethylene Glycol 3350 as an API

Polyethylene glycol 3350 is a high molecular weight polymer with multiple hydroxyl groups, facilitating its water-solubilizing properties. Chemically, it is characterized by its average molecular weight of approximately 3350 Daltons. The API's purity profile and compliance with pharmacopeia standards (such as USP, EP, and JP) are crucial determinants for sourcing decisions, emphasizing quality assurance, proven manufacturing practices, and regulatory compliance.

Major Global API Producers and Suppliers of PEG 3350

Several manufacturers dominate the global production landscape of PEG 3350, each operating within stringent regulatory frameworks to meet international standards. Notably:

1. BASF
   As one of the world's largest chemical producers, BASF supplies PEG 3350 and related polyethylene glycol derivatives globally. Their manufacturing facilities utilize proprietary processes ensuring high-quality API supply aligns with pharmaceutical standards (USP, EP). BASF's extensive R&D and capacity expansion initiatives position it as a reliable source for pharmaceutical companies.

2. Dow Chemical (Now DowDuPont / DuPont) / DuPont
   DuPont, following the merger and recalcitrant supply chain constraints, remains a significant producer with a focus on medical-grade PEG 3350. Their manufacturing processes adhere to rigorous quality standards, facilitating regulatory approval processes in multiple jurisdictions.

3. LyondellBasell
   Known for its breadth of polymer products, LyondellBasell supplies PEG 3350 to pharmaceutical clients through specialized chemical integrations. Their distribution network spans Americas, EMEA, and Asia, providing scalability for large-volume procurement.

4. Shandong Greatwall Hi-tech (China)
   As a leading Chinese API manufacturer, Greatwall Hi-tech produces PEG 3350 that complies with international standards such as USP and EP. They serve both domestic markets and export to major pharmaceutical firms, often at competitive prices due to localized production costs.

5. Yino Pharm & Chemical (China)
   This Chinese supplier offers PEG 3350 API with adherence to GMP standards. Their strategic positioning in China's competitive API landscape makes them a significant alternative source for cost-sensitive buyers.

6. SACHEM Inc.
   Although more renowned as a specialty chemical company, SACHEM supplies high-quality PEG derivatives, including PEG 3350, to pharmaceutical firms under strict quality controls.

Regional Supply and Manufacturing Dynamics

• North America: The U.S. market primarily relies on domestic producers like BASF and third-party importers. Regulatory agencies such as the FDA mandate high-grade, pharmacopeial-quality API, influencing sourcing choices towards well-established suppliers.

• Europe: EU-based companies, including BASF and other regional producers, supply PEG 3350, with adherence to EMA regulations. Europe emphasizes high regulatory standards and supply chain stability.

• Asia-Pacific: China and India have emerged as major API manufacturing hubs, offering cost-effective options. Chinese manufacturers such as Greatwall Hi-tech and Yino Pharm have significantly increased their share, driven by robust local demand and export incentives.

• Others: Suppliers in South America and Eastern Europe are increasingly penetrating markets via strategic partnerships and licensing agreements, broadening the global supply chain matrix.

Quality Standards and Regulatory Considerations

The pharmaceutical-grade PEG 3350 must conform to pharmacopoeia standards like USP, EP, or JP to meet industry safety and efficacy criteria. This necessitates suppliers to possess comprehensive GMP certification and undergo rigorous quality assurance audits. Asian manufacturers, in particular, have enhanced compliance capacities to meet international regulatory requirements, thereby expanding their market share.

Key Factors Influencing API Sourcing Decisions

• Regulatory Compliance: Ensuring API meets local and international pharmacopoeial standards is paramount.
• Cost and Supply Stability: Competitive pricing coupled with reliable, uninterrupted supply chains influence long-term procurement strategies.
• Quality and Purity Profiles: Higher purity levels and consistent quality are essential, especially for sensitive formulations.
• Manufacturing Capacity: Large-scale capacity allows for bulk procurement, favorable for contract manufacturing organizations.
• Lead Times and Logistics: Proximity of manufacturing facilities, shipping routes, and import/export regulations impact sourcing timelines.

Emerging Trends and Future Outlook

The API landscape for PEG 3350 is evolving, with increasing capacity expansion among Chinese and Indian manufacturers to serve burgeoning demand. Additionally, pharmaceutical companies are exploring alternative sourcing models, including vertical integration, strategic alliances, and regional supplier diversification, to mitigate risks associated with supply disruptions.

Automated screening of suppliers based on compliance status, financial stability, and capacity expansion plans is becoming standard practice. Innovations in process chemistry, such as greener manufacturing methods, could further influence supply chains by enhancing sustainability and reducing costs.

Conclusion

The global sourcing of bulk PEG 3350 APIs is characterized by a mixture of mature Western manufacturers and rapidly expanding Asian suppliers. While quality and regulatory compliance remain non-negotiable, cost considerations and supply flexibility increasingly drive procurement decisions. Strategic partnerships and diversification are essential for mitigating supply chain risks amid fluctuating demand and regulatory environments.

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Key Takeaways

• Major API suppliers for PEG 3350 include BASF, DuPont, and LyondellBasell, complemented by Chinese manufacturers like Greatwall Hi-tech and Yino Pharm.
• Asian suppliers offer cost advantages but must demonstrate compliance with international pharmacopeial standards to be viable for pharmaceutical applications.
• Regulatory adherence, quality assurance, and supply stability are the primary factors influencing sourcing choices.
• Regional dynamics dictate supply chain nuances, with North America and Europe prioritizing regulatory compliance, whereas Asia emphasizes capacity and cost.
• The future of PEG 3350 API sourcing involves diversification, capacity expansion, and green manufacturing initiatives to meet increasing global demand.

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FAQs

Q1: How do I verify the regulatory compliance of a PEG 3350 API supplier?
A: Verify their certifications (GMP, ISO), review their pharmacopoeial compliance (USP, EP, JP), and request analytical and quality assurance documentation. Audits and third-party assessments further confirm compliance.

Q2: Are Chinese manufacturers of PEG 3350 suitable for pharmaceutical applications?
A: Yes, many Chinese manufacturers have achieved GMP certification and comply with international standards, making their APIs suitable for pharmaceutical use, provided proper quality controls are in place.

Q3: What are the key differences between sourcing PEG 3350 from Western vs. Asian suppliers?
A: Western suppliers often emphasize stringent regulatory compliance and quality assurance, potentially at higher costs, while Asian suppliers may offer cost-effective solutions with increasing compliance standards.

Q4: How can supply chain disruptions be minimized when sourcing PEG 3350 API?
A: Diversify suppliers across regions, establish long-term contracts, secure buffer stock, and perform regular supplier audits to ensure consistent supply and quality.

Q5: What is the typical lead time for procuring bulk PEG 3350 API?
A: Lead times vary depending on supplier location and order volume but generally range from 4 to 12 weeks. Early engagement and planning are essential for timely supply.

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References

1. [1] US Pharmacopeia. “Polyethylene Glycol 3350 Monograph,” USP, 2022.
2. [2] European Pharmacopoeia. “Polyethylene Glycol Monograph,” EP, 2022.
3. [3] Industry Reports. “Global API Manufacturing Landscape,” Pharmaceutical Technology, 2022.
4. [4] Company Websites. BASF, DuPont, Greatwall Hi-tech, Yino Pharm.
5. [5] Market Data. “Polyethylene Glycol Market Outlook,” IQVIA, 2023.