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
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760	NDA	RedHill Biopharma Ltd	57841-1301-4	1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK	2020-10-01

Movantik Suppliers Analysis

Last updated: February 19, 2026

What is Movantik and Who Manufactures It?

Movantik (naloxegol) is a peripherally acting mu-opioid receptor antagonist. It is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The active pharmaceutical ingredient (API) is naloxegol. AstraZeneca developed and initially marketed Movantik. In December 2017, AstraZeneca sold the U.S. rights to Movantik to Depomed, Inc., which later rebranded as Assertio Therapeutics. In March 2020, Assertio Therapeutics divested the U.S. rights for Movantik to Daiichi Sankyo, Inc. [1, 2, 3]. Consequently, Daiichi Sankyo is the current U.S. marketer of Movantik.

What are the Key Raw Materials and Intermediates for Naloxegol Synthesis?

The synthesis of naloxegol is a multi-step process involving several key raw materials and intermediates. While precise manufacturing routes are proprietary, typical synthetic pathways for opioid antagonists involve derivatization of precursor molecules. The core structure of naloxegol is derived from naloxone.

Key components and intermediates likely involved in the synthesis include:

• Naloxone: This is the fundamental precursor. Naloxone is an opioid antagonist itself.
• Polyethylene Glycol (PEG) derivatives: Naloxegol is a PEGylated derivative of naloxone. Specifically, it involves the attachment of a PEG chain to the naloxone molecule. Common PEGylation reagents used in pharmaceutical synthesis include activated PEGs like PEG-NHS esters or PEG-halides. The specific PEG chain length for naloxegol is a defined 2000 Da chain.
• Reaction Solvents: Various organic solvents are employed for chemical reactions, purifications, and isolations. Common examples include alcohols (methanol, ethanol), esters (ethyl acetate), ethers (tetrahydrofuran), and chlorinated solvents (dichloromethane).
• Reagents for Functionalization: Specific reagents are required for activating hydroxyl groups on the naloxone molecule or the PEG chain for efficient coupling. This could involve activating agents like carbodiimides (e.g., DCC, EDC) or other coupling reagents.
• Catalysts: Depending on the specific synthetic steps, catalysts may be employed to accelerate reaction rates or improve selectivity.
• Purification Agents: Materials for chromatographic purification (e.g., silica gel) and crystallization (solvents) are essential for achieving the required purity of the API.

Who are the Potential Suppliers of Key Raw Materials and Intermediates?

Identifying specific suppliers for a proprietary drug like Movantik is challenging due to the confidential nature of pharmaceutical supply chains. However, based on the likely raw materials and intermediates, the following types of companies and their general roles can be identified:

API Precursor Suppliers (e.g., Naloxone)

Naloxone itself is a well-established pharmaceutical ingredient, with multiple manufacturers globally. Companies that produce opioid antagonists or their precursors are potential suppliers.

• General Chemical Manufacturers: Large chemical companies with extensive portfolios in pharmaceutical intermediates are often involved in producing precursor molecules.
• Specialized API Manufacturers: Firms focusing on opioid-related compounds or complex organic synthesis.

Polyethylene Glycol (PEG) Derivative Suppliers

The supply of PEG derivatives is critical for the PEGylation process.

• Specialty Chemical Companies: Companies that focus on polymers, particularly polyethers, are key suppliers. Examples include:
  • Merck KGaA (Sigma-Aldrich): Offers a wide range of activated PEGs and custom PEGylation services.
  • NOF Corporation: A major supplier of functionalized PEGs for pharmaceutical applications.
  • JenKem Technology: Specializes in custom PEGylation services and offers various activated PEGs.
  • Creative PEGworks: Provides a broad spectrum of PEG derivatives for biopharmaceutical and chemical applications.

The specific PEG chain length (2000 Da) and functionalization required for naloxegol would necessitate a supplier capable of producing high-purity, well-characterized PEGylation reagents of this specific molecular weight.

Solvents and Reagent Suppliers

The broader pharmaceutical industry relies on a vast network of suppliers for bulk and specialty solvents and reagents.

• Major Chemical Distributors: Companies like Thermo Fisher Scientific, VWR International, and MilliporeSigma supply a comprehensive range of laboratory and industrial chemicals.
• Bulk Chemical Manufacturers: Large-scale producers of common organic solvents (e.g., methanol, ethanol, ethyl acetate, dichloromethane) and inorganic reagents.

What are the Regulatory Considerations for Movantik Suppliers?

Suppliers to pharmaceutical manufacturers like Daiichi Sankyo must adhere to stringent regulatory requirements to ensure the quality, safety, and efficacy of the final drug product.

Good Manufacturing Practices (GMP)

All suppliers of APIs, critical intermediates, and excipients must operate under current Good Manufacturing Practices (cGMP). This applies to facilities, equipment, personnel, manufacturing processes, quality control, and documentation. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce GMP standards.

Drug Master Files (DMFs)

Suppliers of APIs often submit Drug Master Files (DMFs) to regulatory authorities. A DMF is a submission to the FDA providing confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows the drug product applicant (Daiichi Sankyo) to reference the DMF in their New Drug Application (NDA) without having direct access to the confidential information.

Supplier Audits and Qualification

Pharmaceutical companies conduct rigorous audits and qualification processes for their suppliers. This involves assessing the supplier's quality systems, manufacturing capabilities, compliance history, and financial stability. Regular re-audits are typically performed.

Purity and Impurity Profiling

Suppliers must demonstrate consistent control over the purity of their materials and provide detailed impurity profiles. Any potential impurities that could carry over into the final drug product must be identified, quantified, and controlled within acceptable limits, as defined by ICH guidelines (e.g., ICH Q3A, Q3B).

Traceability and Supply Chain Security

Suppliers must maintain robust systems for traceability, allowing for the tracking of raw materials from origin through to delivery. Supply chain security measures are also crucial to prevent counterfeiting and ensure product integrity.

What are the Global Manufacturing Locations for Naloxegol API and Movantik Drug Product?

The specific manufacturing sites for naloxegol API and the finished Movantik drug product are proprietary information held by Daiichi Sankyo and their contracted manufacturers. However, based on industry trends and prior information:

• API Manufacturing: API synthesis often occurs in facilities specializing in complex organic chemistry. This can be in countries with established pharmaceutical manufacturing infrastructure and skilled labor. Historically, companies like AstraZeneca have had API manufacturing capabilities in Europe and North America, as well as outsourcing to contract manufacturing organizations (CMOs) in Asia (e.g., India and China). It is probable that the naloxegol API is manufactured by a specialized CMO or a dedicated facility under contract.
• Drug Product Manufacturing (Finished Dosage Form): The formulation of naloxegol into tablets, packaging, and labeling also occurs in GMP-compliant facilities. This can be in-house by Daiichi Sankyo or at contract manufacturing organizations (CMOs) specializing in finished dosage forms. Given Daiichi Sankyo's global presence, manufacturing could occur in North America, Europe, or Asia, depending on market supply requirements and cost-effectiveness.

Companies that provide contract manufacturing services for both API synthesis and finished drug product manufacturing are key players. These include:

• Lonza Group
• Catalent Pharma Solutions
• Thermo Fisher Scientific (Patheon)
• CMOs in India and China

Key Takeaways

• Movantik (naloxegol) is marketed in the U.S. by Daiichi Sankyo, Inc.
• The synthesis of naloxegol requires precursors like naloxone and specialized polyethylene glycol (PEG) derivatives.
• Suppliers of PEGylation reagents, such as NOF Corporation, JenKem Technology, and Creative PEGworks, are critical.
• All suppliers must operate under stringent cGMP regulations and undergo rigorous qualification by the pharmaceutical manufacturer.
• Drug Master Files (DMFs) are commonly used by API suppliers to facilitate regulatory submissions.
• Precise API and drug product manufacturing sites are proprietary but likely involve specialized CMOs in addition to potential in-house capabilities.

FAQs

1. What is the primary API for Movantik? The primary API for Movantik is naloxegol.

2. Who is the current marketer of Movantik in the United States? Daiichi Sankyo, Inc. is the current marketer of Movantik in the United States.

3. What type of chemical modification is central to naloxegol's structure compared to its precursor? Naloxegol is a polyethylene glycol (PEG)-conjugated derivative of naloxone.

4. What regulatory standard must API suppliers for Movantik adhere to? API suppliers must adhere to current Good Manufacturing Practices (cGMP).

5. Are there publicly listed facilities that manufacture the naloxegol API? No, the specific manufacturing facilities for the naloxegol API are proprietary and not publicly disclosed.

Citations

[1] AstraZeneca. (2015). Movantik™ (naloxegol) prescribing information. [Press release]. [2] Assertio Therapeutics, Inc. (2018). Assertio Therapeutics Announces Acquisition of U.S. Rights to Movantik®. [Press release]. [3] Daiichi Sankyo, Inc. (2020). Daiichi Sankyo Acquires U.S. Rights to Movantik® from Assertio Therapeutics. [Press release].