nulytely-flavored: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Braintree	NULYTELY-FLAVORED	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical market for bowel preparation solutions has experienced steady growth, driven by increasing gastrointestinal disorders and the expanding need for effective diagnostic procedures such as colonoscopies. Nulytely-Flavored, a popular oral polyethylene glycol (PEG)-based bowel prep, is widely used to cleanse the bowel prior to diagnostic examinations. Its efficacy, palatability, and safety profile have positioned it as a preferred choice among clinicians and patients alike. Securing reliable suppliers for Nulytely-Flavored involves understanding the product's manufacturing landscape, key players, supply chain intricacies, and regulatory environment.

Overview of Nulytely-Flavored

Nulytely-Flavored, developed by pharmaceutical companies specializing in gastrointestinal solutions, combines PEG 3350 with electrolytes and flavoring agents to improve taste. The product's formulation adheres to strict regulatory standards to ensure safety and efficacy. Marketed primarily in the United States and other developed markets, Nulytely-Flavored requires a dedicated supply chain that maintains ingredient quality, regulatory compliance, and distribution logistics.

Key Suppliers and Manufacturers

1. Pharmaceutical Manufacturers

Most Nulytely-Flavored products are produced by major pharmaceutical companies that specialize in gastrointestinal agents. These manufacturers often serve as Original Equipment Manufacturers (OEMs), or they may sell finished products directly to distributors and healthcare providers.

Braintree Laboratories, Inc.
As the original producer of Nulytely, Braintree Laboratories holds a significant role in manufacturing and supplying this product. They formulate the branded product, ensuring quality and regulatory adherence. Braintree’s manufacturing facility is FDA-approved, and they maintain strict Good Manufacturing Practice (GMP) standards.
Ferring Pharmaceuticals
Ferring supplies generic versions of PEG-based bowel preps, including flavored variants similar to Nulytely. They possess extensive manufacturing capabilities for sterile liquids, electrolytes, and flavoring agents vital for the product.
S.L. Pharma
A generic pharmaceutical company producing PEG-based bowel preparation solutions, including flavored formulations. Their manufacturing facilities are GMP-compliant, and they supply primarily to North American and European markets.

2. Contract Manufacturing Organizations (CMOs)

In many cases, pharmaceutical companies outsource manufacturing to specialized CMOs, which provide high-quality production, scale-up, and filling services.

Famar (GMP Contract Manufacturer)
Famar offers contract manufacturing for sterile liquids and has the capacity for flavoring and packaging Nulytely-Flavored products.
Catalent, Inc.
A global leader in drug development and manufacturing, Catalent supplies formulation, flavoring, and filling services for gastrointestinal solutions, including PEG-based bowel preps.
Recipharm
Recipharm specializes in liquid and sterile product manufacturing and has produced flavored PEG solutions for various clients, ensuring supply stability and compliance.

3. Ingredient Suppliers

The primary components of Nulytely-Flavored include PEG 3350, electrolytes, and flavoring agents.

Dow Chemical Company
Supplies PEG 3350 used in bowel preparation solutions, adhering to pharmaceutical grade standards.
Pharmaceutical-grade Electrolyte Manufacturers
Companies like Fresenius Kabi and Baxter International supply high-purity electrolytes essential for formulation stability and patient safety.
Flavoring Agents Suppliers
Major flavor manufacturers such as Symrise and Givaudan produce pharmaceutical-grade flavoring agents used in Nulytely-Flavored, offering customization to meet taste preferences and regulatory requirements.

Supply Chain Considerations

Securing a reliable supply of Nulytely-Flavored hinges on multiple factors:

Regulatory Compliance: Manufacturers and suppliers must comply with FDA, EMA, and other relevant regulatory standards, including GMP certifications, prior to product approval and distribution.
Quality Assurance: Stringent quality control processes, including batch testing and stability assessments, ensure the consistency and safety of the product.
Raw Material Availability: The global supply of PEG 3350 and electrolytes can be affected by geopolitical, environmental, or logistical issues, influencing production timelines.
Flavoring Customization: Variability in flavoring formulations must meet patient preferences and regulatory guidelines, necessitating collaborations with specialized flavoring suppliers.
Distribution Logistics: Cold chain maintenance, packaging integrity, and inventory management are critical to prevent product degradation, especially with flavored solutions that may have additional perishability concerns.

Major Market Players and Competitive Landscape

While Braintree Laboratories remains a primary manufacturer of the branded Nulytely, the market sees significant participation from generic producers and contract manufacturers, providing cost-effective alternatives and increasing supply breadth.

Proprietary vs. Generic: The market is divided between branded formulations and generics, with many generic suppliers focused on production, quality, and regulatory compliance to gain market share.
Geographical Diversification: European and Asian manufacturers are increasingly entering the market, supplying both finished products and bulk ingredients to meet global demand.
Partnership & Licensing Models: Strategic licensing agreements between brand owners and third-party manufacturers enable expanded distribution channels and enhanced supply chain resilience.

Regulatory and Patent Landscape

Patent protections around the original formulations have expired in many jurisdictions, facilitating entry by generic manufacturers. However, trademark protections for Nulytely-Favored and related branding elements remain vital for branding and market differentiation.

Manufacturers must adhere to stringent regulatory dossiers, including Chemistry, Manufacturing, and Controls (CMC) documentation, to maintain product approvals. Supply chain security is also reinforced through compliance with the Drug Supply Chain Security Act (DSCSA) in the U.S. and equivalent global standards.

Emerging Trends and Future Outlook

Innovation in Flavoring Technologies: Continued efforts to improve palatability and patient compliance are driving innovation in flavoring techniques and formulations.
Supply Chain Digitization: Advanced tracking, serialization, and real-time inventory monitoring enhance supply chain transparency and reduce risks of shortages.
Sustainable Manufacturing: Environmental considerations influence ingredient sourcing and manufacturing processes, with stakeholders aiming to reduce carbon footprints.
Global Expansion: To meet increasing demand, manufacturers are expanding capacity in emerging markets, emphasizing localization and regulatory adaptation.

Key Takeaways

The primary supplier of Nulytely-Flavored is Braintree Laboratories, complemented by generic manufacturers and CMOs like Catalent and Recipharm, which provide manufacturing and formulation capabilities.
Ingredient sourcing, especially PEG 3350 and electrolytes, is critical; trusted suppliers include Dow Chemical, Fresenius Kabi, and Baxter.
Regulatory compliance, quality assurance, and supply chain resilience are paramount to maintaining steady availability in a competitive market.
Market dynamics increasingly favor generic formulations, with global expansion and innovation in flavoring boosting supply options.
Strategic partnerships between brand owners, CMOs, and ingredient suppliers underpin the continuity and cost-efficiency of supply.

FAQs

Q1: Who are the main manufacturers of Nulytely-Flavored?
A1: The original manufacturer is Braintree Laboratories, with generic versions produced by companies such as Ferring Pharmaceuticals, S.L. Pharma, Catalent, and Recipharm.

Q2: What are the key raw ingredients supplied for Nulytely-Flavored?
A2: The primary raw ingredients include PEG 3350 (supplied by Dow Chemical), electrolytes (by Fresenius Kabi or Baxter), and flavoring agents (by Symrise, Givaudan).

Q3: How does supply chain regulation impact Nulytely-Flavored?
A3: Strict adherence to GMP, FDA, and international standards ensures product quality, safety, and regulatory approval, which is essential for uninterrupted supply.

Q4: Are there regional differences in suppliers for Nulytely-Flavored?
A4: Yes. While North America relies heavily on Braintree and regional generic producers, Europe and Asia involve local manufacturers and ingredient suppliers, facilitating global distribution.

Q5: What emerging trends could influence future Nulytely-Flavored supply?
A5: Advances in flavoring technologies, digitization of supply chains, sustainability efforts, and regional manufacturing expansion are shaping future supply dynamics.

Conclusion

Securing reliable suppliers for Nulytely-Flavored involves a comprehensive understanding of formulation ingredients, manufacturing capabilities, regulatory landscapes, and logistical considerations. The interplay among brand manufacturers, generic producers, CMOs, and ingredient suppliers underpins the resilience and scalability of the supply chain. As demand for bowel preparation solutions grows, particularly in the context of minimally invasive diagnostics, fostering collaborative relationships and investing in supply chain innovations will remain critical for maintaining product availability and market competitiveness.

References

[1] Braintree Laboratories, Inc. Official Website.
[2] Ferring Pharmaceuticals Product Catalog.
[3] Catalent Corporate Overview.
[4] Dow Chemical—Pharmaceutical Grade PEG 3350 Specifications.
[5] FDA Guidelines for Oral Bowel Preparation Solutions.

Suppliers and packagers for nulytely-flavored