Suppliers and packagers for GOLYTELY

GOLYTELY

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011	NDA AUTHORIZED GENERIC	Affordable Pharmaceuticals, LLC	10572-100-01	4 L in 1 JUG (10572-100-01)	2009-07-01
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-6521-0	4 L in 1 JUG (50090-6521-0)	2009-07-01
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011	NDA	Braintree Laboratories, Inc.	52268-100-01	4 L in 1 BOTTLE, PLASTIC (52268-100-01)	1984-07-13

Suppliers for the Pharmaceutical Drug: GOLYTELY

Last updated: August 1, 2025

Introduction

GOLYTELY, a trademarked brand of polyethylene glycol (PEG) electrolyte solution, functions as a potent colon-cleansing agent primarily prescribed for bowel preparation before colonoscopy procedures. Its efficacy, safety profile, and widespread use make it a critical product in diagnostic gastroenterology. Successfully distributing and manufacturing GOLYTELY hinges on a complex supply chain involving multiple key suppliers across raw materials, manufacturing, and distribution networks.

This analysis focuses on key suppliers involved in the production of GOLYTELY, including raw material providers, contract manufacturers, and distributors. Understanding these suppliers is vital for stakeholders considering market entry, supply chain resilience, or competitive positioning within the gastrointestinal pharmaceutical segment.

Raw Material Suppliers

Polyethylene Glycol (PEG) Raw Material

PEG, the primary active ingredient in GOLYTELY, is a polymer derived from ethylene oxide and water. The quality, molecular weight distribution, and purity of PEG are crucial to ensuring the safety and efficacy of GOLYTELY.

• Major PEG Manufacturers:

  • Dow Chemical Company: A leading producer offering varying molecular weight PEGs suitable for pharmaceutical applications (Dow’s PEG products are extensively used in formulations due to their high purity and well-characterized profiles).
  • BASF: Provides pharmaceutical-grade PEG with high purity standards, including PEG 3350, which closely aligns with the PEG used in GOLYTELY.
  • Lotte Chemical: An emerging supplier with capabilities to produce pharmaceutical-grade PEGs, particularly in Asian markets.

• Quality Considerations:

  • Suppliers must comply with Good Manufacturing Practices (GMP) and adhere to pharmacopeia standards such as the U.S. Pharmacopeia (USP) or European Pharmacopoeia (EP).
  • Purity levels exceeding 99% and low levels of residual monomers are essential for safe oral administration.

Electrolytes and Additives

GOLYTELY also contains electrolytes—sodium chloride, sodium bicarbonate, sodium sulfate, and potassium chloride—to prevent dehydration and electrolyte imbalance.

• Electrolyte Suppliers:

  • Nephron Pharmaceuticals: Supplies pharmaceutical-grade electrolytes with consistent quality.
  • Jordan Industries: Offers USP-grade electrolytes optimized for oral solutions.
  • Infinity Pharmaceuticals: Provides custom electrolyte mixes suitable for pre-formulated solutions like GOLYTELY.

• Source Requirements:

  • Suppliers must ensure high purity, trace element control, and compatibility with the formulation.

Formulation and Contract Manufacturing

Contract Manufacturing Organizations (CMOs)

Production of GOLYTELY involves complex formulation, blending, sterilization, and packaging processes. Several CMOs with pharmaceutical manufacturing facilities globally handle this process:

• Global Contract Manufacturers:

  • Generics and branded drug manufacturers such as Fresenius Kabi, Baxter International, and Fresenius Medical Care often serve as primary CMOs or co-packers for GOLYTELY, given their extensive experience in gastrointestinal preparations.
  • Specialized aseptic fill-finish facilities ensure sterile packaging in soft, pre-measured drink formats.

• Manufacturing Standards:

  • GMP compliance is non-negotiable, with certifications from regulatory authorities such as the FDA, EMA, or WHO.
  • Facilities undergo rigorous validation for sterilization, stability, and safety testing.

Formulation Expertise

• The key to successful GOLYTELY production involves precise formulation processes ensuring consistent electrolyte and PEG concentrations, palatability, and stability over shelf life.

Distribution and Logistics

Distribution Partners

Distribution of GOLYTELY involves pharmacy chains, hospital suppliers, and specialty pharmacies:

• Major Distributors:

  • McKesson Healthcare
  • AmerisourceBergen
  • Cardinal Health
    These distributors source GOLYTELY directly from manufacturers or wholesalers, ensuring widespread availability across the U.S. and globally.

• Specialty Pharmacies:

  • Pharmacies specializing in gastrointestinal and diagnostic products play a critical role in reaching end-users efficiently.

Supply Chain Challenges

• Cold Chain and Storage:
  While GOLYTELY does not require refrigeration, maintaining product stability requires controlled storage conditions during distribution.
• Regulatory Compliance:
  Ensuring regulatory compliance across different regions, including import/export controls and quality standards, is vital for uninterrupted supply.

Market Dynamics and Key Players

The primary manufacturer and supplier of GOLYTELY in the United States is Ferring Pharmaceuticals, which markets the product under the GOLYTELY brand. Ferring relies on a global supply chain, sourcing raw materials from multiple international suppliers and leveraging contract manufacturing organizations for production.

Contract manufacturing is also performed by third-party providers in Europe and Asia, especially considering regional regulatory manufacturing requirements. The global nature of these supply chains introduces both resilience and vulnerability, particularly amid geopolitical tensions and supply chain disruptions such as those seen during the COVID-19 pandemic.

Future Outlook and Supply Chain Innovations

Emerging trends include:

• Alternative Raw Materials: Development of synthetic or bioengineered PEG variants may diversify supplier bases and reduce dependency on traditional chemical producers.
• Supply Chain Digitization: Leveraging blockchain and IoT for traceability and quality assurance, reducing counterfeiting and ensuring compliance.
• Sustainable Sourcing: Focus on environmentally responsible PEG production, including reducing energy use and waste in manufacturing processes.

Conclusion

The supply of GOLYTELY is a sophisticated ecosystem involving high-quality raw material providers, specialized contract manufacturers, and efficient distribution channels. Its success depends on procurement of pharmaceutical-grade PEG and electrolytes, adherence to GMP standards during manufacturing, and a robust logistics infrastructure to ensure timely delivery.

Stakeholders must maintain close relationships with trusted suppliers like Dow Chemical, BASF, and Nephron Pharmaceuticals, while continuously monitoring geopolitical and regulatory risks. Enhancing transparency and diversifying sources will be critical to sustain supply continuity amid evolving global challenges.

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Key Takeaways

• Identifying reliable raw material suppliers such as Dow Chemical and BASF is fundamental to ensuring the quality of GOLYTELY.
• Contract manufacturing partners must comply with GMP standards and possess extensive experience in sterile gastrointestinal formulations.
• Distribution networks involving major healthcare distributors facilitate widespread availability but require vigilant supply chain management.
• Supply chain resilience can be enhanced by diversifying suppliers, leveraging technology, and adopting sustainable manufacturing practices.
• Regulatory compliance remains critical; aligning with global standards diminishes risks of disruptions or recalls.

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FAQs

1. Who are the primary raw material suppliers for GOLYTELY?
   The main suppliers of PEG and electrolytes include Dow Chemical, BASF, Nephron Pharmaceuticals, and Jordan Industries, chosen for their ability to produce pharmaceutical-grade, high-purity materials.

2. What role do contract manufacturers play in GOLYTELY production?
   Contract manufacturers handle formulation, blending, sterilization, and packaging, adhering strictly to GMP standards to ensure product quality and safety.

3. How is GOLYTELY distributed globally?
   Major distributors such as McKesson, AmerisourceBergen, and Cardinal Health distribute GOLYTELY to hospitals, pharmacies, and specialty clinics, supported by regional manufacturing bases.

4. What are the supply chain risks associated with GOLYTELY?
   Risks include raw material shortages, geopolitical factors, transportation disruptions, and regulatory inconsistencies, which can impact timely production and delivery.

5. Are there alternative suppliers or formulations for GOLYTELY?
   While Ferring Pharmaceuticals remains the primary source, emerging biosimilar and generic versions, along with alternative PEG formulations, are under development to diversify supply sources.

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References

1. [1] Dow Chemical Company, Pharmaceutical PEG Products, 2022.
2. [2] BASF, Pharmaceutical Grade PEG Specifications, 2021.
3. [3] FDA Guidelines on Injectable and Oral PEG Materials, 2020.
4. [4] Nephron Pharmaceuticals, Pharmaceutical Electrolytes Supply Chain, 2022.
5. [5] Ferring Pharmaceuticals, GOLYTELY Production and Supply Chain Overview, 2021.