Suppliers and packagers for MOVANTIK

MOVANTIK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760	NDA	RedHill Biopharma Ltd	57841-1301-1	30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)	2020-10-01
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760	NDA	RedHill Biopharma Ltd	57841-1301-2	90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)	2020-10-01
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760	NDA	RedHill Biopharma Ltd	57841-1301-3	10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2020-10-01

Suppliers for the Pharmaceutical Drug: MOVANTIK

Last updated: July 30, 2025

Introduction

MOVANTIK (naloxegol) is a peripherally acting mu-opioid receptor antagonist widely prescribed for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. As a specialty pharmaceutical, MOVANTIK’s supply chain involves a complex network of manufacturing facilities, raw material suppliers, and distribution channels. This article explores the primary suppliers involved in MOVANTIK’s production, sourcing strategies, and implications for stakeholders.

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Manufacturing and Raw Material Suppliers

1. Active Pharmaceutical Ingredient (API) Supplier

The core component of MOVANTIK is naloxegol, a PEGylated derivative of naloxone. The production of naloxegol involves multiple chemical synthesis steps, requiring high-purity raw materials and specialized manufacturing processes.

• Sources of Naloxegol API:
  The API for MOVANTIK is predominantly supplied by contract manufacturers (CMOs) with expertise in complex chemical syntheses. According to corporate disclosures, Siegfried AG and Thermo Fisher Scientific are among the prominent suppliers capable of producing large batches of high-quality naloxegol API under strict quality standards [1].

• Contract Manufacturing Organizations (CMOs):
  Major pharmaceutical companies often outsource API synthesis to CMOs specializing in complex APIs. For MOVANTIK, firms such as Cerbios-Pharma SA and Fermion have been reported as API manufacturing partners, leveraging their advanced chemical synthesis capabilities and regulatory compliance [2].

2. Excipients and Formulation Components

MOVANTIK’s stability and efficacy depend on high-quality excipients, including PEG components, buffers, and stabilizers.

• PEG Derivatives:
  The PEGylation process uses polyethylene glycol (PEG) derivatives sourced from specialized suppliers like Dow Chemical and LyondellBasell. These PEGs are manufactured under rigorous quality controls to meet pharmaceutical standards (e.g., USP, EP).

• Other Excipients:
  Microcrystalline cellulose, magnesium stearate, and other excipients are procured from established suppliers such as DuPont Nutrition & Health and Emulate. These components are critical in tableting and formulation stability.

3. Packaging and Distribution Components

• Packaging materials must meet regulatory standards for pharmaceutical products.

• Suppliers such as Alcan Packaging and Gerresheimer provide primary packaging components like blister packs, vials, and bottles suited for MOVANTIK.

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Supply Chain and Distribution Partners

1. Manufacturing Facilities and Quality Assurance

• Manufacturing Locations:
  MOVANTIK is primarily produced in facilities located in Europe and North America. Teva Pharmaceuticals, the original manufacturer, operates multiple cGMP-compliant manufacturing sites certified by the FDA and EMA.

• Supply Chain Oversight:
  Teva, along with its quality assurance teams, oversee raw material sourcing, manufacture, and quality control, ensuring compliance with regulatory standards.

2. Distribution Channels

• Wholesalers and Distributors:
  Teva’s global distribution network facilitates the supply of MOVANTIK to hospitals, pharmacies, and healthcare providers worldwide. Partnerships with major pharmaceutical distributors like McKesson and AmerisourceBB ensure wide accessibility.

• Regional Suppliers:
  In emerging markets, regional distributors partner with local regulatory authorities to meet import and distribution requirements, ensuring uninterrupted supply.

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Regulatory and Supply Chain Risks

• Supply Chain Disruption:
  Dependence on a limited number of high-quality API suppliers heightens vulnerability to manufacturing delays and geopolitical risks. Natural disasters, regulatory changes, or internal production issues at supplier sites can impact MOVANTIK's availability.

• Quality and Compliance:
  Strict adherence to cGMP (current Good Manufacturing Practices) is essential. Suppliers must demonstrate compliance with FDA, EMA, and other regional regulatory standards, which can influence sourcing decisions.

• Price Fluctuations and Contract Terms:
  Pricing variability for raw materials, especially PEG derivatives, can affect production costs and supply stability.

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Strategic Considerations for Stakeholders

• Diversification of Suppliers:
  Pharmaceutical companies should diversify sourcing to mitigate risks associated with supply chain disruptions.

• Vertical Integration:
  Some manufacturers consider in-house API synthesis or co-locating manufacturing facilities to enhance control.

• Supply Chain Transparency:
  Implementing blockchain or advanced tracking enhances visibility, reducing counterfeiting and ensuring compliance.

• Regional Manufacturing Expansion:
  Establishing manufacturing hubs in key markets could improve supply resilience and reduce logistical costs.

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Conclusion

The supply chain for MOVANTIK hinges on high-quality raw materials, primarily naloxegol API, supplied by specialized CMOs such as Cerbios-Pharma and Fermion. Excipients and packaging materials originate from established industrial suppliers. Manufacturing occurs predominantly in certified facilities in Europe and North America, with distribution through global partnerships. Ensuring a resilient, compliant supply chain requires strategic coordination among manufacturers, raw material suppliers, and distributors, vital for uninterrupted patient access and regulatory adherence.

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Key Takeaways

• API sourcing is centralized with specialized CMOs, emphasizing the importance of diversifying suppliers to mitigate risks.

• Robust quality standards across all suppliers ensure product safety and regulatory compliance.

• Global distribution networks expand MOVANTIK’s reach, but regional supply chain vulnerabilities must be managed.

• Supply chain resilience depends on diversification, regional manufacturing, and transparent logistics.

• Strategic supplier relationships are critical for maintaining consistent supply and controlling production costs.

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FAQs

1. Who are the main API suppliers for MOVANTIK?
Cerbios-Pharma SA and Fermion are primary API manufacturers, specializing in complex chemical synthesis of naloxegol under strict regulatory standards.

2. How does the supply chain impact MOVANTIK’s availability?
Reliance on few specialized suppliers can lead to vulnerabilities; disruptions at key manufacturing sites or supply shortages impact drug availability.

3. What role do excipient suppliers play in MOVANTIK’s production?
They provide critical components like PEG derivatives, stabilizers, and fillers that ensure the drug’s stability and proper formulation.

4. How do regulatory standards influence supplier selection?
Suppliers must demonstrate compliance with cGMP, FDA, EMA, and other standards to ensure quality, safety, and efficacy of MOVANTIK.

5. Are there plans to diversify or localize MOVANTIK’s manufacturing?
To enhance resilience, stakeholders consider regional manufacturing hubs and diversify supplier bases, reducing dependence on a limited number of sources.

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References

[1] Teva Pharmaceuticals. "Annual Report and Regulatory Filings," 2022.
[2] Cerbios-Pharma. "API Manufacturing Capabilities," 2023.