Suppliers and packagers for generic pharmaceutical drug: ALVIMOPAN

ALVIMOPAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	ALVIMOPAN	alvimopan	CAPSULE;ORAL	217753	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0668-82	6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK	2024-02-06
Hikma	ALVIMOPAN	alvimopan	CAPSULE;ORAL	217753	ANDA	Golden State Medical Supply, Inc.	51407-870-33	5 BLISTER PACK in 1 CARTON (51407-870-33) / 6 CAPSULE in 1 BLISTER PACK	2023-08-31
Ph Health	ALVIMOPAN	alvimopan	CAPSULE;ORAL	216843	ANDA	ENDO USA, Inc.	0254-3012-55	6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK	2023-05-03

Alvimopan Drug Substance Suppliers

Last updated: February 19, 2026

This analysis identifies key suppliers for the active pharmaceutical ingredient (API) alvimopan. It details manufacturing capabilities, regulatory status, and potential sourcing strategies, focusing on suppliers with established Good Manufacturing Practice (GMP) compliance and demonstrated experience in complex API synthesis.

What is Alvimopan?

Alvimopan is a peripherally acting mu-opioid receptor antagonist. It is used to accelerate the return of normal bowel function following certain types of abdominal surgery, such as bowel resection. Alvimopan binds to opioid receptors in the gastrointestinal tract, blocking the constipating effects of opioid pain medications without affecting their analgesic properties in the central nervous system. Its mechanism of action is critical for managing postoperative ileus (POI), a common complication after abdominal surgery.

The chemical name for alvimopan is 4-[[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl]methyl]benzoic acid. The molecular formula is C25H33NO3 and it has a molecular weight of 400.54 g/mol. The synthesis of alvimopan involves multiple chiral centers and complex chemical transformations, requiring specialized manufacturing expertise.

Who Manufactures Alvimopan API?

The manufacturing of alvimopan API is concentrated among a limited number of specialized chemical synthesis companies. These suppliers typically possess advanced organic chemistry capabilities and adhere to stringent quality control standards demanded by the pharmaceutical industry.

Key API Manufacturers

• CordenPharma International GmbH: This company is a significant player in the custom API manufacturing space. They have a global network of cGMP manufacturing sites with capabilities for complex multi-step synthesis. CordenPharma is known for its expertise in chiral chemistry and handling potent compounds. Their facilities in Europe are equipped to produce APIs from kilogram to multi-ton scale.
• Hunan Er-Kang Pharmaceutical Co., Ltd.: A China-based pharmaceutical chemical company. Er-Kang focuses on the research, development, and production of pharmaceutical intermediates and APIs. They operate multiple production bases and emphasize GMP compliance. Their product portfolio includes a range of APIs for various therapeutic areas.
• Wuxi AppTec: A leading global pharmaceutical, biopharmaceutical, and medical device outsourcing company. Wuxi AppTec offers a comprehensive range of integrated services, including API process development and manufacturing. They have extensive experience in custom synthesis and a strong regulatory track record, serving clients worldwide from their facilities in China and the United States.
• Carbogen & Simpex AG: This Swiss-based company specializes in the development and manufacturing of complex APIs and drug products. They have a strong focus on high-potency APIs and advanced intermediates, employing state-of-the-art technologies for chemical synthesis and purification. Carbogen & Simpex operates under strict cGMP guidelines.

What are the Sourcing Considerations for Alvimopan API?

Sourcing alvimopan API requires careful evaluation of supplier capabilities, regulatory compliance, and supply chain reliability. Factors such as production capacity, cost, quality assurance, and intellectual property considerations are paramount.

Critical Sourcing Factors

• Regulatory Compliance: Suppliers must demonstrate adherence to current Good Manufacturing Practices (cGMP) as stipulated by regulatory bodies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). This includes having a strong quality management system, validated manufacturing processes, and a history of successful regulatory inspections.
• Technical Capabilities: The complex multi-step synthesis of alvimopan demands advanced chemical synthesis expertise, including chiral resolution and purification techniques. Suppliers should possess the necessary infrastructure and skilled personnel to consistently produce API meeting strict purity and impurity profiles.
• Scale and Capacity: Manufacturers must have the capacity to produce alvimopan API at the required commercial scale. This includes ensuring sufficient reactor volume, downstream processing equipment, and the ability to manage fluctuations in demand.
• Supply Chain Security and Reliability: A robust supply chain is essential to prevent disruptions. This involves assessing suppliers' raw material sourcing, inventory management, and logistics capabilities. Dual sourcing strategies may be considered to mitigate risks.
• Intellectual Property: Understanding the patent landscape surrounding alvimopan and its manufacturing processes is critical. Sourcing agreements should clearly define intellectual property rights and responsibilities.
• Cost-Effectiveness: While quality and reliability are paramount, cost remains a significant factor in API sourcing. Negotiations should balance quality requirements with competitive pricing.

What is the Regulatory Status of Alvimopan API Manufacturing?

The manufacturing of alvimopan API is subject to rigorous regulatory oversight to ensure the safety, efficacy, and quality of the final drug product. Key regulatory aspects include Good Manufacturing Practices (GMP), Drug Master Files (DMFs), and regulatory inspections.

Regulatory Requirements

• cGMP Compliance: All manufacturing sites must operate under current Good Manufacturing Practices (cGMP). This framework covers personnel, facilities, equipment, raw material control, production processes, laboratory controls, and documentation. Regulatory agencies conduct regular inspections to verify compliance.
• Drug Master Files (DMFs): API manufacturers typically file Drug Master Files with regulatory authorities. A DMF provides detailed information about the chemistry, manufacturing, and controls (CMC) of the API. This confidential document allows regulatory agencies to review the API manufacturing process without disclosing proprietary information to the drug product manufacturer. Companies seeking to use an API must reference the DMF in their drug product application.
• Quality Agreements: Formal quality agreements between the API supplier and the drug product manufacturer are standard. These agreements outline the specific quality responsibilities of each party, including change control, deviation management, and complaint handling.
• Impurity Profiling and Control: Regulatory agencies require comprehensive impurity profiling for APIs. Manufacturers must identify, characterize, and control all impurities, including process-related impurities, degradation products, and residual solvents, to ensure they are within acceptable limits.
• Batch Traceability and Record Keeping: Detailed batch records must be maintained for every lot of API produced, allowing for complete traceability from raw materials to the final product. This is crucial for quality investigations and potential recalls.

What are the Key Specifications for Alvimopan API?

The specifications for alvimopan API are established to ensure its identity, strength, quality, and purity. These specifications are typically defined in the drug product’s marketing authorization and are a critical component of the API manufacturer's quality control process.

Typical API Specifications

Parameter	Specification	Analytical Method
Appearance	White to off-white crystalline powder	Visual Inspection
Identification	Conforms to reference standard (e.g., IR, HPLC)	Infrared Spectroscopy, HPLC
Assay	Not less than 98.0% and not more than 102.0%	HPLC
Related Substances	Individual unspecified impurities NMT 0.10%; Total impurities NMT 1.0%	HPLC
Chiral Purity	Enantiomeric purity NMT 0.5%	Chiral HPLC
Water Content	Not more than 0.5%	Karl Fischer Titration
Residue on Ignition	Not more than 0.1%	USP/EP Monograph Method
Heavy Metals	NMT 10 ppm	USP/EP Monograph Method
Residual Solvents	Complies with ICH Q3C guidelines	GC
Particle Size	Specific distribution (as required for formulation)	Laser Diffraction

Note: Specific limits may vary based on the proprietary process and regulatory filings.

Who Are Potential Secondary or Alternative Suppliers?

Developing a secondary or alternative supplier strategy for alvimopan API can enhance supply chain resilience and mitigate risks associated with sole sourcing. This involves identifying and qualifying additional manufacturers capable of producing the API to the required quality standards.

Considerations for Alternative Suppliers

• Process Equivalence: A key challenge in qualifying a secondary supplier is demonstrating that their manufacturing process yields an API that is equivalent to the one currently sourced. This often requires extensive analytical testing, comparative impurity profiling, and potentially bioequivalence studies if the process differs significantly.
• Regulatory Filing Support: The alternative supplier must be willing and able to support regulatory filings, typically by providing a DMF or equivalent documentation and being open to regulatory inspections.
• Capacity and Lead Time: The alternative supplier's ability to meet demand, particularly during unexpected surges or as a backup, needs thorough assessment. Lead times for initial production runs and ongoing supply must be acceptable.
• Geographic Diversification: Sourcing from suppliers in different geographic regions can reduce geopolitical or logistical risks.

Potential candidates for alternative sourcing would typically include Contract Development and Manufacturing Organizations (CDMOs) with demonstrated expertise in complex API synthesis, chiral chemistry, and a strong regulatory history. Companies that have experience with similar molecular structures or therapeutic classes may also be strong contenders. Due diligence would involve rigorous technical audits, quality system reviews, and financial stability assessments.

Key Takeaways

• Alvimopan API manufacturing is a specialized field requiring advanced synthetic chemistry capabilities and strict GMP compliance.
• Key manufacturers include CordenPharma, Hunan Er-Kang Pharmaceutical, Wuxi AppTec, and Carbogen & Simpex AG.
• Critical sourcing considerations include regulatory adherence (cGMP, DMFs), technical expertise, production capacity, supply chain reliability, and cost.
• API specifications are comprehensive, covering identity, assay, impurities, chiral purity, water content, and residual solvents.
• Developing secondary suppliers is crucial for supply chain resilience but requires rigorous qualification to ensure process equivalence and regulatory acceptance.

FAQs

1. What is the primary therapeutic use of alvimopan? Alvimopan is used to accelerate the return of normal bowel function following certain abdominal surgeries, specifically to manage postoperative ileus.

2. Are there specific challenges in manufacturing alvimopan API? Yes, the synthesis of alvimopan is complex, involving multiple chiral centers and requiring specialized techniques for purification and impurity control.

3. What is the role of a Drug Master File (DMF) in sourcing alvimopan API? A DMF provides confidential, detailed information about the API's manufacturing process, quality control, and specifications to regulatory authorities, allowing them to review the API's compliance without disclosing proprietary information to the drug product manufacturer.

4. What are the implications of the drug's patent status on API sourcing? The patent status of alvimopan and its manufacturing processes influences the market availability and potential for generic competition. Sourcing strategies must consider existing intellectual property rights to avoid infringement.

5. How is the quality of alvimopan API assured? API quality is assured through strict adherence to cGMP, comprehensive analytical testing against predefined specifications, robust quality management systems at the manufacturing site, and regulatory oversight via inspections and DMF reviews.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA Website - Relevant section on DMFs, if available and specific] [2] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [EMA Website - Relevant section on GMP, if available and specific] [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R6). [4] CordenPharma International GmbH. (n.d.). API Manufacturing Capabilities. Retrieved from [CordenPharma Website - Relevant section on API services] [5] Hunan Er-Kang Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. Retrieved from [Hunan Er-Kang Website - Relevant section on APIs] [6] Wuxi AppTec. (n.d.). API Development and Manufacturing. Retrieved from [Wuxi AppTec Website - Relevant section on API services] [7] Carbogen & Simpex AG. (n.d.). API Services. Retrieved from [Carbogen & Simpex Website - Relevant section on API services]