Bulk Pharmaceutical API Sources for HALFLYTELY

Bulk Pharmaceutical API Sources for HALFLYTELY

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jmw`P@K@Qv^QQZIKJJJIIKEJBdfiVmP@U@@@EL@@@
MP Biomedicals		210023
NovoSeek		2391
Vitas-M Laboratory		STK293202
MolPort		MolPort-002-045-454
ABI Chem		AC1L1DKN
AKos Consulting & Solutions		AKOS001599884

Bulk Active Pharmaceutical Ingredient (API) Sources for Halflytely

Last updated: July 29, 2025

---

Introduction

Halflytely, a bowel preparation agent primarily composed of polyethylene glycol (PEG) combined with electrolytes, is essential in preparing patients for diagnostic procedures such as colonoscopy. While the active ingredient in Halflytely is PEG 3350, the formulation also includes electrolytes like sodium chloride, sodium bicarbonate, and sodium sulfate, which facilitate osmotic activity to cleanse the bowel effectively. For pharmaceutical manufacturing and distribution, sourcing high-quality bulk APIs, notably PEG 3350, is crucial. This document explores the landscape of bulk API sources for the active ingredients in Halflytely, focusing on PEG 3350, electrolytes, and associated raw materials.

---

Understanding the API Components in Halflytely

PEG 3350:
Polyethylene glycol 3350 is a high-molecular-weight polymer classified under osmotic laxatives, facilitating water retention in the stool. Its pharmaceutical-grade grade is essential for safety and efficacy.

Electrolytes:

• Sodium chloride (NaCl)
• Sodium bicarbonate (NaHCO₃)
• Sodium sulfate (Na₂SO₄)

These components restore electrolyte balance and aid in osmotic activity.

---

Global API Manufacturers for PEG 3350

The procurement of PEG 3350 involves sourcing from global, validated suppliers with robust manufacturing practices compliant with pharmacopeial standards (USP, EP, JP).

Leading API Manufacturers

1. Siegfried AG (Switzerland):
   A key producer of PEG grades, including PEG 3350, with extensive R&D focused on pharmaceutical excipients and APIs. Siegfried's PEG is ISO-certified and widely used in bowel preparation formulations.

2. BASF SE (Germany):
   A major global chemical producer offering PEG derivatives suitable for pharmaceutical applications. BASF’s PEG products meet stringent quality and safety standards.

3. Dow Chemical (United States):
   Dow supplies pharmaceutical-grade PEGs, including PEG 3350, with a comprehensive portfolio backed by GMP compliance and a global distribution network.

4. LG Chem (South Korea):
   An emerging supplier of PEGs with high purity and consistent quality, catering to pharmaceutical manufacturers seeking reliable sources.

5. Hanwha Chemical (South Korea):
   Provides PEG grades including PEG 3350, emphasizing high-quality standards aligned with pharma requirements.

Regional and Other Notable Suppliers

• Ashland Global Holdings: Offers pharmaceutical-grade PEGs used in bowel preparations.
• Shandong Siruitan Chemical Co., Ltd (China): Provides PEG 3350 with competitive pricing, subject to strict quality control.
• MeadWestvaco (now part of WestRock): Historically supplied PEG for pharmaceutical and OTC products.

---

Electrolyte Raw Material Suppliers

Electrolyte components are sourced from reputable chemical suppliers that guarantee pharmaceutical-grade purity. International standards such as USP or EP are mandatory for compatibility in medicinal products.

1. Sigma-Aldrich (Merck Group, USA/Germany):
   Offers USP-grade sodium chloride, sodium bicarbonate, and sodium sulfate for pharmaceutical use, tested for impurity profiles.

2. Fisher Scientific (USA):
   Supplies high-quality electrolytes compliant with pharmacopeial standards.

3. Mallinckrodt Pharmaceuticals:
   Provides electrolytes specifically formulated for medicinal use, with consistent GMP compliance.

4. Shanghai Richem Chemical Co., Ltd:
   Supplies electrolytes meeting international standards, offering competitive pricing for bulk procurement.

---

Key Considerations When Procuring APIs for Halflytely

• Quality Compliance:
  Ensure suppliers adhere to GMP standards and meet USP, EP, or JP monographs specific to PEG 3350 and electrolytes.

• Supply Chain Reliability:
  Choose suppliers with proven track records in global supply, capable of sustaining large-volume orders with consistent quality.

• Documentation and Certifications:
  Require Certificate of Analysis (CoA), Certificates of Compliance, and batch history documentation for quality assurance.

• Regulatory Compatibility:
  Confirm that supplies meet the regulatory requirements of target markets, including FDA, EMA, and other regional authorities.

---

Emerging Trends and Alternative Sources

• Chinese API Manufacturers:
  An increasing number of Chinese companies are manufacturing PEG 3350 and electrolytes, often providing cost advantages. Notable companies include Shanghai GLYA Chemicals and Shandong Binzhou Detergent Co., Ltd.

• Localized Production:
  Some regional pharmaceutical hubs are developing indigenous API manufacturing capabilities, reducing reliance on imports and increasing supply chain resilience.

• Sustainability and Green Chemistry:
  Suppliers emphasizing environmentally sustainable manufacturing processes are gaining favor, aligning with global regulatory and social expectations.

---

Regulatory and Quality Assurance Considerations

Secure APIs only from suppliers compliant with current Good Manufacturing Practices (cGMP). Confirm that APIs carry necessary certifications, including EMA or FDA approval for excipients and active ingredients, depending on market jurisdiction.

---

Conclusion

Bulk sourcing of APIs for Halflytely, particularly PEG 3350, is a critical component of manufacturing efficiency and product quality. Leading global API manufacturers such as Siegfried, BASF, and Dow provide pharmaceutical-grade PEG 3350 suitable for bowel preparation formulations. Complementary electrolytes sourced from reputable suppliers like Sigma-Aldrich ensure the formulation’s safety and efficacy.

Procuring APIs from validated, quality-assured suppliers is essential to meet regulatory standards and ensure consistent therapeutic outcomes. As manufacturing landscapes evolve, regional suppliers and innovative manufacturers continue to expand options, enhancing flexibility and supply chain resilience.

---

Key Takeaways

• Prioritize GMP-compliant API suppliers to ensure safety, quality, and regulatory compatibility.
• PEG 3350 remains the primary API in Halflytely, with multiple reputable international manufacturers available.
• Electrolyte sourcing should be aligned with pharmacopeial standards to prevent formulation variability.
• Supply chain diversification reduces risks associated with dependency on a single source.
• Stay informed about emerging regional manufacturers and sustainability initiatives, which influence procurement strategies.

---

FAQs

1. What are the main factors to consider when sourcing PEG 3350 for Halflytely?
Quality compliance (GMP, pharmacopeial standards), supplier reliability, documentation (CoA), and regulatory approvals are paramount considerations.

2. Are there regional differences in bulk API availability for Halflytely?
Yes, while Europe and North America dominate supply, Chinese and Korean manufacturers are increasing their market presence, often offering competitive prices but requiring thorough quality verification.

3. Can electrolytes be sourced from multiple suppliers without affecting formulation consistency?
Yes, provided all sources meet the same pharmacopeial specifications and quality standards, ensuring uniformity in electrolyte composition.

4. What risks are associated with sourcing APIs from less established suppliers?
Risks include inconsistent quality, supply disruptions, regulatory non-compliance, and potential safety issues, emphasizing the need for due diligence.

5. How does regulatory approval influence API sourcing for Halflytely?
APIs must comply with regional regulatory standards (FDA, EMA), with validated documentation and certifications required for approval and market access.

---

References:
[1] U.S. Pharmacopeia Monograph for PEG 3350.
[2] European Pharmacopoeia Standard for PEGs and electrolytes.
[3] Siegfried AG Product Portfolio.
[4] BASF SE Chemical Inventory.
[5] Dow Chemical Solutions.