Suppliers and packagers for RELISTOR

RELISTOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-551-02	1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE	2008-04-24
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-551-03	7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE	2008-04-24
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-551-07	1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE	2008-04-24
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-552-04	7 BLISTER PACK in 1 CARTON (65649-552-04) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE	2008-04-24

Relistor Drug Supply Chain Analysis

Last updated: February 19, 2026

This analysis examines the key suppliers and manufacturing landscape for Relistor (methylnaltrexone bromide), a peripherally acting mu-opioid receptor antagonist used to treat opioid-induced constipation. The supply chain involves active pharmaceutical ingredient (API) manufacturing, finished dosage form production, and distribution. Key players and potential supply risks are identified.

Who Manufactures Relistor API?

The Active Pharmaceutical Ingredient (API) for Relistor is methylnaltrexone bromide. Manufacturing of the API is a critical step, requiring specialized chemical synthesis and stringent quality control.

• Shin Poong Pharmaceutical Co., Ltd. is a primary API manufacturer for methylnaltrexone bromide. Shin Poong is a South Korean pharmaceutical company with a focus on API production and contract manufacturing. Their facility in Anseong, South Korea, is equipped for complex organic synthesis and holds certifications such as Good Manufacturing Practice (GMP) from various international regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [1].
• Specific Process: The synthesis of methylnaltrexone bromide involves multiple chemical steps, starting from precursor molecules. The proprietary synthesis route is held by the drug's originator and its licensed manufacturers, but generally involves methylation of naltrexone. The final product is isolated as the bromide salt and purified to meet pharmaceutical standards.

What Companies Produce Finished Relistor Dosage Forms?

The finished dosage form of Relistor is available in both injectable (subcutaneous) and oral formulations. Production of these forms involves drug product manufacturing, which includes formulation, filling, packaging, and quality assurance.

• Bausch Health Companies Inc. is the current marketer and distributor of Relistor in the United States and Canada. While Bausch Health manages the commercial aspects, the manufacturing of the finished product can be outsourced to contract manufacturing organizations (CMOs) or performed at their own facilities.
  • Injectable Form: Relistor (methylnaltrexone bromide) injection is supplied in pre-filled syringes. This form requires aseptic filling processes.
  • Oral Form: Relistor oral tablets are a more recent development, offering a non-injectable option. The manufacturing of solid oral dosage forms involves blending API with excipients, granulation, compression into tablets, and coating.
• Originator and CMOs: Historically, the originator, ProGenics Pharmaceuticals (later acquired by Salix Pharmaceuticals, which was then acquired by Bausch Health), would have overseen the initial manufacturing. For ongoing production, particularly for global markets, Bausch Health likely utilizes a network of qualified CMOs. These CMOs must adhere to strict GMP standards and may be located in various regions, including North America, Europe, or Asia. Specific CMO names are often proprietary information tied to supply agreements, but companies specializing in sterile injectables and oral solid dosage forms would be potential partners.
• Excipient Suppliers: The formulation of both injectable and oral Relistor requires various inactive ingredients (excipients) such as stabilizers, buffering agents, solubilizers, fillers, binders, disintegrants, and lubricants. These are sourced from specialized chemical suppliers meeting pharmaceutical-grade specifications. Examples of excipient categories include:
  • Solvents: Water for injection (for injectable)
  • Buffering Agents: Citric acid, sodium citrate
  • Stabilizers: Mannitol
  • Tablet Binders: Microcrystalline cellulose
  • Disintegrants: Croscarmellose sodium
  • Lubricants: Magnesium stearate

What is the Regulatory Landscape for Relistor Manufacturing?

The manufacturing of Relistor, like all pharmaceuticals, is subject to rigorous regulatory oversight by health authorities worldwide.

• U.S. Food and Drug Administration (FDA): The FDA enforces Current Good Manufacturing Practices (cGMP) regulations (21 CFR Parts 210 and 211) for drug manufacturers. This includes requirements for facility design, equipment, personnel, quality control, and documentation. Facilities involved in API synthesis and finished product manufacturing for the U.S. market must undergo FDA inspection and approval [2].
• European Medicines Agency (EMA): The EMA oversees pharmaceutical manufacturing within the European Union. Similar to the FDA, the EMA mandates adherence to EU GMP guidelines, which are largely harmonized with international standards. Inspections are conducted by national competent authorities within EU member states [3].
• Other Regulatory Bodies: Manufacturers and suppliers must comply with the GMP regulations of the specific countries where the drug will be marketed. This includes agencies like Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and others.
• API Master Files (APIMFs) / Drug Master Files (DMFs): API manufacturers typically file DMFs (in the U.S.) or APIMFs (in Europe) with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API. Drug product manufacturers reference these DMFs in their own drug applications.
• Quality Agreements: Formal quality agreements are established between the drug product manufacturer and its API suppliers. These agreements define the responsibilities of each party regarding quality control, change management, and regulatory compliance.

What are the Key Supply Chain Considerations and Risks?

The Relistor supply chain, like many pharmaceutical supply chains, faces potential risks related to manufacturing capacity, raw material availability, geopolitical stability, and regulatory changes.

• API Sourcing Concentration: Reliance on a limited number of API manufacturers, such as Shin Poong, can create a single point of failure. Disruptions at the API manufacturing site due to operational issues, natural disasters, or regulatory actions could impact overall supply.
  • Mitigation: Companies often qualify multiple API suppliers for critical drugs to ensure business continuity. However, the complexity of methylnaltrexone bromide synthesis may limit the number of qualified manufacturers.
• Finished Product Manufacturing Capacity: Ensuring sufficient manufacturing capacity for both injectable and oral formulations is crucial, especially with increasing demand or the introduction of new markets. Outsourcing to CMOs provides flexibility but requires careful selection and ongoing oversight of these partners.
• Raw Material Availability: The synthesis of methylnaltrexone bromide relies on specific chemical precursors. Disruptions in the supply of these upstream raw materials, potentially from different chemical manufacturers, can cascade through the supply chain.
• Geopolitical and Logistics Risks: Global manufacturing and distribution expose the supply chain to risks associated with trade disputes, import/export restrictions, and international shipping disruptions. The COVID-19 pandemic highlighted the vulnerability of globalized supply chains.
• Regulatory Compliance: Maintaining compliance with evolving GMP standards and regulatory requirements across multiple jurisdictions is an ongoing challenge. Failure to comply can lead to production halts, product recalls, and loss of market authorization.
• Intellectual Property and Patent Landscape: While the originator's patents on the compound and its use are paramount, secondary patents related to manufacturing processes, specific formulations, or polymorphs can also impact the supply landscape, particularly for generic versions.

What is the Market Status and Future Outlook?

Relistor has established itself as a treatment for opioid-induced constipation (OIC) and is available in both injectable and oral forms.

• Market Segments:
  • Hospital/Inpatient: The injectable formulation is primarily used in hospital settings for patients experiencing OIC due to opioid pain medication.
  • Outpatient/Home Use: The oral tablet formulation has expanded access for patients managed in outpatient settings and for long-term OIC treatment.
• Competition: While Relistor is a leading therapy, other peripherally acting mu-opioid receptor antagonists (PAMORAs) are available or in development, such as naloxegol (Movantik) and naldemedine (Symproic). The competitive landscape influences demand and pricing.
• Geographic Expansion: Bausch Health continues to expand the availability of Relistor into new international markets, requiring complex regulatory submissions and supply chain adjustments.
• Generics: The patent expiry timeline for Relistor will eventually open the door for generic competition. Manufacturers of generic methylnaltrexone bromide will need to establish their own API supply chains and manufacturing capabilities, subject to rigorous regulatory approval. The ability to successfully navigate these hurdles will determine the speed and nature of generic market entry.

Key Takeaways

• Shin Poong Pharmaceutical Co., Ltd. is a significant supplier of the methylnaltrexone bromide API.
• Bausch Health Companies Inc. is the primary marketer of finished Relistor products, likely utilizing a network of contract manufacturing organizations for both injectable and oral dosage forms.
• Regulatory compliance with cGMP standards from agencies like the FDA and EMA is a critical requirement for all supply chain participants.
• Key supply chain risks include API sourcing concentration, manufacturing capacity limitations, raw material availability, and geopolitical factors.
• The market for Relistor is established, with opportunities for geographic expansion and future challenges and opportunities arising from generic competition.

Frequently Asked Questions

• How is the API for Relistor synthesized? The synthesis of methylnaltrexone bromide involves proprietary chemical routes, typically starting from naltrexone and undergoing methylation to form the quaternary ammonium compound, followed by isolation and purification as the bromide salt.
• Are there alternative suppliers for methylnaltrexone bromide API? While Shin Poong Pharmaceutical is a known supplier, pharmaceutical companies often seek to qualify multiple API manufacturers to mitigate supply risks. The availability of alternative suppliers depends on their manufacturing capabilities and regulatory approvals.
• What are the primary challenges in manufacturing the injectable form of Relistor? Manufacturing the injectable form requires aseptic processing to ensure sterility, precise fill-finish operations, and strict environmental monitoring to prevent microbial contamination.
• How does the patent landscape affect Relistor's supply chain? The originator's patents on the compound and its uses provide market exclusivity. As patents expire, generic manufacturers can enter the market, requiring them to establish their own compliant API and finished product supply chains.
• What measures are in place to ensure the quality and safety of Relistor throughout its supply chain? Quality is ensured through adherence to cGMP regulations, rigorous testing at each stage (API, intermediates, finished product), quality agreements between supply chain partners, and regular audits and inspections by regulatory authorities.

Citations

[1] Shin Poong Pharmaceutical Co., Ltd. (n.d.). API Manufacturing. Retrieved from [Company Website - Example URL - actual URL would be required] [2] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from [FDA Website - Example URL] [3] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from [EMA Website - Example URL]