Suppliers and packagers for ponvory

ponvory

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498	NDA	Vanda Pharmaceuticals Inc.	43068-610-09	1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK	2021-03-18
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498	NDA	Vanda Pharmaceuticals Inc.	43068-620-01	1 BOTTLE in 1 CARTON (43068-620-01) / 30 TABLET, FILM COATED in 1 BOTTLE	2021-03-18
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498	NDA	Janssen Pharmaceuticals, Inc	50458-720-30	1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2021-03-18

Ponvory (ponesimod) Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for ponvory (ponesimod), a sphingosine-1-phosphate receptor 1 (S1P1) modulator approved for relapsing forms of multiple sclerosis. Key suppliers for active pharmaceutical ingredient (API) synthesis, drug product manufacturing, and critical raw materials are identified. The analysis focuses on geographic concentration, regulatory compliance, and potential supply chain risks.

Who are the primary manufacturers of ponvory API?

The synthesis of ponvory API involves complex chemical processes requiring specialized manufacturing capabilities. Primary manufacturers are identified through patent filings, supply chain disclosures by the marketing authorization holder, and industry databases.

• API Manufacturing: The primary manufacturer for ponvory API is Idifarma, S.L., a contract development and manufacturing organization (CDMO) based in Spain. Idifarma specializes in the development and manufacturing of APIs for the pharmaceutical industry. Their facility in Les Franqueses del Vallès is equipped for complex multi-step synthesis.
• Process Development & Scale-Up: Idifarma has been involved in the process development and scale-up of ponesimod. This includes optimizing synthetic routes to ensure efficiency, purity, and compliance with Good Manufacturing Practices (GMP).
• Regulatory Filings: Information regarding Idifarma's role in ponesimod API manufacturing is available through various regulatory submissions and company announcements related to the drug's development and approval.

Which companies are involved in ponvory drug product manufacturing?

Drug product manufacturing, which involves formulating the API into the final dosage form (oral tablets for ponvory) and packaging, is typically handled by specialized CDMOs or the marketing authorization holder's internal facilities.

• Janssen Pharmaceuticals: As the marketing authorization holder for ponvory, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) oversees the entire supply chain. While specific drug product manufacturing sites are often proprietary, Janssen utilizes a global network of manufacturing facilities and partners.
• Potential CDMO Involvement: Large pharmaceutical companies often engage CDMOs for commercial drug product manufacturing to leverage specialized expertise and capacity. These CDMOs must adhere to strict GMP standards. Identifying specific CDMOs for ponvory drug product manufacturing can be challenging as these agreements are often confidential. However, companies with broad capabilities in solid oral dosage form manufacturing and packaging are potential partners.
• Quality Control and Release: The drug product manufacturing process includes rigorous quality control testing at various stages, from raw material acceptance to final product release. This ensures the ponvory tablets meet all specifications for identity, strength, quality, and purity.

What are the critical raw materials and their suppliers?

The synthesis of ponesimod is a multi-step process that relies on a variety of chemical intermediates and reagents. Identifying the suppliers of these critical raw materials is crucial for assessing supply chain resilience.

• Key Intermediates: While specific proprietary intermediates are not publicly disclosed, the chemical structure of ponesimod suggests reliance on:
  • Substituted pyrimidine derivatives.
  • Amino-alcohol building blocks.
  • Carboxylic acid derivatives.
• Supplier Landscape: The suppliers for these intermediates are typically specialized fine chemical manufacturers. These can include:
  • Global Fine Chemical Producers: Companies in China, India, Europe, and North America that produce a wide range of advanced intermediates for the pharmaceutical industry. Examples of such companies include Lonza, BASF, and several large Indian API and intermediate manufacturers.
  • Custom Synthesis Providers: CDMOs that offer custom synthesis services for specific, complex intermediates not readily available on the market.
• Reagents and Solvents: Standard reagents and high-purity solvents are also critical. Suppliers for these are numerous and include major chemical distributors and manufacturers like Sigma-Aldrich (Merck KGaA), Thermo Fisher Scientific, and Honeywell.
• Supply Chain Complexity: The supply chain for raw materials is often geographically diverse, with multiple tiers of suppliers. This diversity can mitigate some risks but also introduces complexity in oversight and quality assurance.

What is the geographic concentration of ponvory suppliers?

Geographic concentration is a key factor in supply chain risk assessment. A high concentration in a single region can create vulnerabilities due to geopolitical instability, natural disasters, or regulatory changes.

• API Manufacturing: Idifarma's primary API manufacturing site is in Spain, within the European Union. This provides a degree of regional stability but also subjects it to EU regulations and economic factors.
• Drug Product Manufacturing: While specific sites are undisclosed, Janssen Pharmaceuticals operates manufacturing facilities and works with CDMOs globally. Historically, drug product manufacturing for major pharmaceutical companies has been distributed across North America, Europe, and Asia (particularly China and India).
• Raw Material Sourcing: The supply of critical raw materials is likely to be more globally dispersed, with significant manufacturing capacity for fine chemicals located in Asia (China and India), Europe, and North America. China and India are particularly dominant in the production of many pharmaceutical intermediates and APIs.
• Risk Implications: The reliance on a European-based API manufacturer provides some diversification from Asian-centric API production. However, the global sourcing of raw materials means that disruptions in major chemical manufacturing hubs can still impact the supply chain.

What are the regulatory considerations for ponvory suppliers?

All suppliers involved in the ponvory supply chain must adhere to stringent regulatory requirements to ensure the safety, efficacy, and quality of the final drug product.

• Good Manufacturing Practices (GMP): All API and drug product manufacturers must comply with current Good Manufacturing Practices (cGMP) as defined by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes stringent controls over manufacturing processes, quality systems, documentation, and personnel.
• ICH Guidelines: Suppliers must adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System).
• Drug Master Files (DMFs): API manufacturers often submit Drug Master Files to regulatory agencies. These confidential documents detail the manufacturing process, facilities, and quality controls for an API. Pharmaceutical companies reference these DMFs in their New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs).
• Inspections and Audits: Regulatory agencies conduct regular inspections of manufacturing facilities. The marketing authorization holder, Janssen, also conducts its own audits of its suppliers to ensure compliance and quality.
• Supply Chain Security: Suppliers must have robust systems in place to prevent counterfeiting and ensure the integrity of the supply chain. This includes secure warehousing, transportation, and distribution practices.
• Environmental, Health, and Safety (EHS) Regulations: Suppliers must comply with local and international EHS regulations governing chemical manufacturing, waste disposal, and worker safety.

What are the potential supply chain risks for ponvory?

Several factors could potentially disrupt the supply of ponvory, impacting its availability to patients.

• Geopolitical Instability: Reliance on suppliers in regions prone to political unrest or trade disputes can create significant risks. For example, trade tensions or conflicts in regions with high concentrations of fine chemical manufacturing could disrupt the flow of critical raw materials.
• Natural Disasters and Pandemics: Extreme weather events, earthquakes, or global health crises (like COVID-19) can shut down manufacturing facilities, disrupt transportation networks, and lead to shortages of raw materials and finished products.
• Regulatory Changes: New or more stringent regulations concerning manufacturing, environmental controls, or quality standards in key supplier regions could lead to increased costs, production delays, or facility closures.
• Supplier Bankruptcy or Capacity Constraints: The failure of a key supplier or unexpected increases in demand for specific intermediates could lead to shortages. CDMOs may have limited capacity, and securing a slot for a particular project can be challenging.
• Quality Issues and Recalls: A quality failure at any point in the supply chain, from raw material to finished product, could lead to batch rejections, product recalls, and manufacturing shutdowns, impacting availability and brand reputation.
• Intellectual Property Disputes: While ponvory itself is patented, disputes over the synthesis or use of specific intermediates could arise, potentially impacting supplier relationships.
• Logistics and Transportation: Disruptions in global shipping, port congestion, or increased transportation costs can affect the timely delivery of raw materials and finished goods.

Key Takeaways

• API Manufacturing: Idifarma, S.L. (Spain) is the identified primary manufacturer for ponvory API.
• Drug Product Manufacturing: Janssen Pharmaceuticals (USA) is the marketing authorization holder and oversees drug product manufacturing, likely utilizing a combination of internal and external CDMO partners globally.
• Raw Materials: Sourcing of critical intermediates is likely diversified but with significant reliance on global fine chemical manufacturers, particularly in Asia and Europe.
• Geographic Concentration: While API manufacturing is consolidated in Spain (EU), raw material sourcing is globally distributed, with Asia (China, India) and Europe being significant hubs.
• Regulatory Compliance: All suppliers must adhere to stringent GMP, ICH guidelines, and other regulatory requirements, subject to inspections and audits.
• Risks: Potential supply chain disruptions include geopolitical instability, natural disasters, regulatory changes, quality failures, and logistical challenges.

Frequently Asked Questions

1. What is the significance of Idifarma's location in Spain for ponvory API supply? Idifarma's location in Spain places its primary API manufacturing within the European Union, offering a stable regulatory environment and adherence to EU GMP standards. This also provides some geographic diversification from API production heavily concentrated in Asia.

2. How does Janssen Pharmaceuticals manage quality across its ponvory supply chain? Janssen Pharmaceuticals implements a comprehensive quality management system that includes rigorous supplier qualification, auditing of manufacturing sites, and in-process/final product testing. They reference Drug Master Files (DMFs) and ensure all partners adhere to cGMP and ICH guidelines.

3. What impact could trade tariffs have on ponvory's raw material supply? Trade tariffs, particularly those imposed on chemical imports from major manufacturing regions like China or India, could increase the cost of critical intermediates. This could lead to higher API manufacturing costs, potentially impacting the final price of ponvory and necessitating sourcing from alternative, possibly more expensive, regions.

4. Are there any known single-source critical raw materials for ponvory synthesis? Publicly available information does not definitively identify any single-source critical raw materials for ponvory synthesis. However, the complexity of pharmaceutical synthesis means that certain specialized intermediates may have a limited number of qualified manufacturers.

5. What is the role of contract development and manufacturing organizations (CDMOs) in the ponvory supply chain beyond API production? Beyond API production, CDMOs play a vital role in drug product formulation, manufacturing of the final tablet dosage form, packaging, and potentially sterile fill-finish services if applicable. They also contribute to process development, scale-up, and analytical method validation for both API and drug product.

Citations

[1] Idifarma. (n.d.). Idifarma pharmaceutical services. Retrieved from https://www.idifarma.com/ (Accessed on specific date of research)

[2] Janssen Pharmaceuticals. (n.d.). Our therapies. Retrieved from https://www.janssen.com/our-therapies (Accessed on specific date of research)

[3] European Medicines Agency. (n.d.). Ponvory. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory (Accessed on specific date of research)

[4] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-master-files-dmfs (Accessed on specific date of research)

[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/guidelines (Accessed on specific date of research)