Bulk Pharmaceutical API Sources for GOLYTELY

Bulk Pharmaceutical API Sources for GOLYTELY

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		qKcQSDZ@d|`lt@@
NovoSeek		516892
MolPort		MolPort-003-926-303
ABI Chem		AC1LANJA
ABI Chem		AC1Q1W5G

Bulk Active Pharmaceutical Ingredient (API) Sources for GOLYTELY

Last updated: July 28, 2025

Introduction
GOLYTELY is a commonly prescribed oral solution primarily used for bowel cleansing prior to colonoscopy or other gastrointestinal procedures. Its active pharmaceutical ingredient (API), polyethylene glycol 3350 (PEG 3350), is a large-volume, osmotic laxative that induces diarrhea by retaining water in the intestinal lumen. Ensuring a reliable, high-quality source of PEG 3350 is critical for manufacturing GOLYTELY, impacting drug safety, efficacy, and regulatory compliance. This review evaluates key bulk API suppliers, sourcing considerations, and industry trends relevant to PEG 3350 for GOLYTELY production.

Overview of PEG 3350 as API for GOLYTELY
PEG 3350 is a high-molecular-weight polyether compound used extensively in pharmaceutical formulations, notably as an osmotic laxative. Its bulk synthesis involves complex, scalable polymerization processes, often requiring stringent quality controls due to the sensitive nature of its medical application. The API must meet pharmacopoeial standards, including purity (absence of low-molecular-weight oligomers or contaminants), residual solvent levels, and extensive testing for endotoxins and microbial limits.

Global API Manufacturing Landscape for PEG 3350
The manufacturing landscape for PEG 3350 is concentrated across a handful of countries, primarily in the United States, China, India, and parts of Europe. The industry is characterized by a mix of well-established multinational chemical and pharmaceutical companies alongside emerging producers, each varying in scale, certification, and regulatory footprint.

Major API Suppliers for GOLYTELY’s PEG 3350

1. Global Chemical and Pharmaceutical Giants
Major multinational corporations dominate the production of PEG 3350, leveraging their extensive R&D and quality assurance protocols:

• BASF SE (Germany): A leader in specialty chemicals, BASF produces PEG derivatives, including PEG 3350, adhering to strict quality standards like pharmacopoeial monographs and USP requirements. BASF’s global manufacturing facilities ensure supply continuity and compliance with Good Manufacturing Practices (GMP).

• Dow Inc. (USA): Dow manufactures PEGs at multiple facilities worldwide, emphasizing quality, environmental compliance, and regulatory adherence. Their PEG products are frequently used as API intermediates and excipients in pharmaceuticals.

• Lotte Chemical (South Korea): A significant producer, Lotte Chemical offers PEG grades suitable for pharmaceutical applications worldwide, with comprehensive quality testing and regulatory certifications.

2. Leading Chinese API and Chemical Producers
China’s petrochemical sector features numerous API-grade PEG producers that serve both domestic and international markets:

• Shandong Meida Chemical Co., Ltd.: A growing supplier focusing on PEG and related polymers, offering products that meet pharmacopeial standards for API use. Their manufacturing facilities are often certified under ISO and GMP, facilitating export into regulated markets.

• Yantai Sanny Chemical Co., Ltd.: Specializes in PEG derivatives, including PEG 3350 suitable for pharmaceutical API manufacturing, with competitive pricing driven by local raw material availability.

• Shenzhen Runke Biotechnology Co., Ltd.: A newer entrant with emphasis on quality control, ISO certifications, and GMP compliance, positioning itself as a reliable source for safe, high-quality PEG 3350.

3. Indian Manufacturers
India’s pharmaceutical sector benefits from a robust chemical manufacturing industry, producing PEG 3350 meeting stringent regulatory standards:

• Sands Corporation: An established API manufacturer providing pharmaceutical-grade PEG 3350 with documented compliance to Indian and international pharmacopeias.

• Hetero Labs: Known for complex APIs and intermediates, Hetero offers PEG grades suitable for GOLYTELY production, with an emphasis on quality and pricing competitiveness.

• Gufic Biosciences: Supplies pharmaceutical excipients, including PEG derivatives meeting USP and other pharmacopeial standards.

4. European API Suppliers
European suppliers prioritize pharmaceutical-grade quality with robust regulatory oversight:

• BASF (Germany): As previously noted, BASF’s European operations uphold high GMP standards for PEG API manufacturing.

• Croda International (UK): Known for specialty chemicals and pharmaceutical excipients, Croda provides PEGs that meet stringent quality criteria suitable for APIs.

Considerations for Sourcing PEG 3350 API for GOLYTELY

Regulatory Compliance
Manufacturers must verify that PEG 3350 APIs meet pharmacopoeial standards such as USP, EP, or JP, including purity, residual solvents, endotoxins, and microbial limits. Ensuring supplier GMP certification and comprehensive quality documentation is essential to mitigate regulatory risks.

Quality Control & Testing
Critical parameters include molecular weight distribution, impurity profiles, residual monomers, and endotoxin levels. Advanced analytical techniques such as GPC, LC-MS, and LAL assays validate API quality, ensuring safety and efficacy.

Raw Material & Supply Chain Stability
Availability of high-purity raw materials (ethylene oxide, propylene oxide) and manufacturing capacity influence supply reliability. Long-term supply agreements and dual sourcing strategies mitigate potential disruptions.

Cost & Pricing Dynamics
Pricing competitiveness varies among suppliers, often influenced by raw material costs, scale efficiencies, and regional economic factors. However, quality and regulatory compliance must take precedence over cost when sourcing APIs for GOLYTELY.

Environmental and Logistic Factors
Regulatory environments concerning environmental standards, import-export regulations, and transportation safety influence sourcing decisions. Suppliers compliant with international environmental protocols tend to maintain higher quality standards.

Industry Trends Impacting API Sourcing for GOLYTELY

Consolidation & Vertical Integration
Major chemical and pharmaceutical firms increasingly consolidate their API portfolios, aiming for integrated control from raw materials to finished API. This trend enhances quality assurance but may limit supplier options.

Emergence of Domestic Producers in Regulated Markets
Countries like India and China are investing heavily to meet global GMP standards, creating more domestic options for PEG 3350 supply, reducing lead times, and lowering costs.

Innovation in Raw Materials
Advancements in biosourced or bio-derived PEG variants are underway, potentially offering cleaner, more sustainable API options compliant with global environmental standards.

Quality Certifications and Regulatory Approvals
ISO, GMP, and other certifications are critical benchmarks. Suppliers with documented compliance tend to be preferred, especially for products used in high-risk, regulated markets like the United States and the European Union.

Supply Chain Resilience Amid Geopolitical Tensions
Recent geopolitical developments have emphasized diversification of supply chains. Companies increasingly seek multiple supplier relationships to mitigate risks associated with tariffs, trade restrictions, or regional disruptions.

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Key Takeaways

• The primary providers of PEG 3350 for GOLYTELY are multinational corporations such as BASF, Dow, and Croda, complemented by leading Chinese, Indian, and European manufacturers.
• Ensuring compliance with pharmacopeial standards, GMP certification, and rigorous quality controls is essential for API sourcing in this therapeutic area.
• Supply chain stability is enhanced by international diversification, long-term agreements, and continuous quality assurance.
• Industry trends — including consolidation, regulatory compliance, and innovation — will influence API sourcing strategies moving forward.
• Cost efficiency must be balanced with quality, regulatory adherence, and supply reliability for optimal procurement decisions.

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FAQs

1. How do I verify the authenticity and quality of PEG 3350 API suppliers?
Verify suppliers’ GMP certifications, pharmacopeial compliance, and perform audits when possible. Request detailed Certificates of Analysis (COA), review quality documentation, and conduct independent testing upon receipt.

2. Are Chinese PEG 3350 API sources considered reliable for pharmaceutical manufacturing?
Yes, many Chinese producers now hold ISO and GMP certifications meeting international standards. However, diligence in validation, qualification, and ongoing quality monitoring is vital.

3. What regulatory considerations are critical when sourcing PEG 3350 API?
Ensure the API complies with USP, EP, or JP monographs, is produced under GMP, and has proper documentation for endotoxin levels, residual solvents, microbial limits, and impurity profiles.

4. How does supply chain diversification benefit GOLYTELY manufacturing?
It reduces dependency on a single source, mitigates risks from geopolitical and logistical disruptions, and ensures consistent API availability, vital for continuous production.

5. What role does environmental sustainability play in API sourcing?
Sustainable practices, including environmentally friendly manufacturing and sourcing bio-based PEG derivatives, are becoming increasingly important for regulatory compliance and corporate responsibility.

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References

1. U.S. Pharmacopeia (USP). Monograph for PEG 3350.
2. European Pharmacopoeia (EP). Standards for Polyethylene Glycols.
3. Industry reports on PEG manufacturing and global API supplier market analysis, 2022–2023.
4. Company websites and product datasheets from BASF, Dow, Croda, and leading Chinese and Indian suppliers.