Suppliers and packagers for NULYTELY

NULYTELY

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	NULYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	019797	NDA AUTHORIZED GENERIC	Affordable Pharmaceuticals, LLC	10572-302-01	4 L in 1 BOTTLE (10572-302-01)	2013-02-08

Suppliers for the Pharmaceutical Drug: Nulytely

Last updated: July 30, 2025

Introduction

Nulytely, a well-known oral bowel cleansing solution, is primarily used to prepare patients for colonoscopy, bowel surgery, or diagnostic procedures. Comprising the active ingredient polyethylene glycol (PEG) combined with electrolytes, Nulytely’s efficacy hinges on its reliable manufacturing and distribution networks. Understanding its suppliers—from raw material producers to finished product manufacturers—is crucial for stakeholders assessing supply chain stability, regulatory compliance, and market positioning.

Overview of Nulytely and Its Market

Developed and marketed by various pharmaceutical companies, Nulytely is recognized for its safety and efficacy, underpinned by strict manufacturing standards. The market for bowel prep solutions has grown steadily due to expanding colorectal cancer screening programs and heightened awareness of gastrointestinal health. This growth increases reliance on supplier networks capable of meeting high-volume demand with consistent quality.

Raw Material Suppliers

At the core of Nulytely’s manufacturing are raw materials—principally polyethylene glycol (PEG) and a specific electrolyte mixture comprising sodium chloride, sodium bicarbonate, and potassium chloride. Each component’s purity and quality directly influence the safety and effectiveness of the final product.

• Polyethylene Glycol (PEG) Suppliers:
  PEG is a synthetic polymer with various molecular weights tailored to pharmaceutical needs. Major chemical manufacturers like Dow Chemical, BASF, and LyondellBasell serve as primary suppliers for pharmaceutical-grade PEG. These companies adhere to stringent manufacturing practices aligned with USP (United States Pharmacopeia) and EP (European Pharmacopeia) standards.

• Electrolyte Components Suppliers:
  Electrolyte powders originate from specialized suppliers such as Fresenius Kabi, Sagent Pharmaceuticals, and Hospira. These firms produce sterile, high-purity electrolyte formulations, ensuring compatibility with PEG solutions.

• Supporting Excipients and Additives:
  While Nulytely largely comprises PEG and electrolytes, other excipients like flavoring agents or buffers are sourced from quality-controlled suppliers, often within the pharmaceutical supply chain to ensure regulatory compliance.

Manufacturers of Nulytely

Pharmaceutical companies involved in the manufacturing of Nulytely or its equivalents rely on a network of contract manufacturing organizations (CMOs) and proprietary facilities.

• Origen and Licensing Agreements:
  Some brands of bowel prep solutions, including Nulytely, are produced under licensing agreements, which dictate specific production standards. For instance, Salix Pharmaceuticals and Ely Lilly have historically been involved in the distribution and manufacturing of such solutions.

• Contract Manufacturing:
  The complexity of producing sterile solutions necessitates GMP-compliant facilities. Companies like Fresenius Kabi and Baxter International often serve as contract manufacturers, leveraging their existing infrastructure to meet global demand efficiently.

• Brand Ownership and Distribution:
  While multiple brands exist, Nulytely’s original formulation was developed by Braintree Laboratories, now part of Salix Pharmaceuticals, a division of Eli Lilly. These entities oversee global distribution, relying on their extensive supply chain networks.

Distribution and Supply Chain

Effective distribution is critical to ensuring timely availability of Nulytely, especially given the product’s importance in preoperative preparation.

• Global Distributors:
  Distributors like McKesson Corporation, AmerisourceBbergen, and Cardinal Health supply pharmacies, hospitals, and clinics worldwide, maintaining inventory levels aligned with demand forecasts.

• Regulatory Agencies and Logistics:
  Supplier networks must comply with Good Distribution Practices (GDP), ensuring product integrity from manufacturing to patient administration. Cold chain logistics are generally not necessary for Nulytely, simplifying distribution parameters.

Regulatory and Quality Assurance

Suppliers and manufacturers must adhere to strict regulatory standards to obtain approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional bodies. Regulatory compliance ensures the purity of raw materials, the sterility of finished products, and overall supply chain integrity.

Emerging Procurement Trends and Supplier Diversification

With increasing demand, pharmaceutical companies are diversifying their supplier base to mitigate risks related to geopolitics, raw material shortages, and supply chain disruptions (as observed during COVID-19). These trends include sourcing PEG from new regions and engaging multiple CMO partners to prevent bottlenecks.

Conclusion

The supply network for Nulytely encapsulates a complex interplay of raw material suppliers, contract manufacturers, and distributors, all operating under stringent regulatory oversight. Key raw material inputs like PEG are supplied by leading chemical manufacturers such as Dow and BASF, while electrolytes are sourced from specialized pharmaceutical excipients producers. The manufacturing process is typically contracted out to GMP-compliant facilities operated by companies like Fresenius Kabi or Baxter. Distribution networks encompass major pharmaceutical logistics providers, ensuring clinical and patient needs are met worldwide.

Key Takeaways

• Reliable sourcing of pharmaceutical-grade PEG and electrolytes from established chemical and excipient suppliers is critical for Nulytely production.
• Contract manufacturing plays a vital role, with companies like Fresenius Kabi serving as key production partners.
• Distribution chains are optimized to maintain product integrity and ensure global availability, with major healthcare distributors managing logistics.
• Regulatory compliance at every supply chain tier safeguards product efficacy and safety, especially pertinent amid increasing supply chain risks.
• Diversification of suppliers and manufacturing sites is a strategic priority to ensure supply continuity amid geopolitical and pandemic-related disruptions.

FAQs

1. Who are the primary raw material suppliers for Nulytely?
Major providers of PEG include Dow Chemical, BASF, and LyondellBasell. Electrolyte components are supplied by pharmaceutical excipient manufacturers like Fresenius Kabi and Hospira.

2. Which companies manufacture and distribute Nulytely globally?
Initially developed by Braintree Laboratories, now part of Salix Pharmaceuticals (Eli Lilly), the product is manufactured under GMP conditions by contract manufacturers such as Fresenius Kabi. Distribution is managed by major healthcare logistics firms like McKesson and Cardinal Health.

3. How does regulatory compliance impact suppliers of Nulytely?
All suppliers must adhere to strict GMP standards and obtain approvals from authorities like the FDA and EMA, ensuring raw materials and final products meet safety and quality benchmarks.

4. Are there alternative suppliers or brands for Nulytely?
Yes. Several generic and branded bowel prep solutions exist, sourced from different manufacturers across countries, often using similar raw materials but distinct formulations or branding.

5. What are current supply chain risks for Nulytely?
Risks include raw material shortages, geopolitical tensions affecting chemical supply routes, regulatory hurdles, and disruptions caused by pandemics. Diversifying suppliers and establishing multiple manufacturing sites mitigate these risks.

Sources

[1] U.S. Food and Drug Administration. "Pharmaceutical Standards and Regulations." FDA Website, 2022.

[2] European Medicines Agency. "Guidelines on Good Manufacturing Practice for Medicinal Products." EMA, 2023.

[3] Dow Chemical, "Polyethylene Glycol (PEG) in Pharmaceutical Applications," Dow Chemical Brochure, 2021.

[4] BASF. "Pharmaceutical Excipients and Raw Materials," BASF Official Website, 2022.

[5] Salix Pharmaceuticals. "Product Portfolio and Manufacturing," Salix Website, 2023.