Suppliers and packagers for generic pharmaceutical drug: PIRFENIDONE

PIRFENIDONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	PIRFENIDONE	pirfenidone	CAPSULE;ORAL	212569	ANDA	AvKARE	42291-490-27	1 BOTTLE in 1 CARTON (42291-490-27) / 270 CAPSULE in 1 BOTTLE	2023-10-18
Amneal	PIRFENIDONE	pirfenidone	CAPSULE;ORAL	212569	ANDA	Amneal Pharmaceuticals NY LLC	60219-1642-7	1 BOTTLE in 1 CARTON (60219-1642-7) / 270 CAPSULE in 1 BOTTLE	2022-01-07
Amneal	PIRFENIDONE	pirfenidone	CAPSULE;ORAL	212569	ANDA	Amneal Pharmaceuticals NY LLC	69238-1642-7	1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE	2022-01-07
Laurus	PIRFENIDONE	pirfenidone	CAPSULE;ORAL	212724	ANDA	Laurus Labs Limited	42385-923-29	270 CAPSULE in 1 BOTTLE (42385-923-29)	2022-07-19

Pirfenidone Drug: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This report analyzes the key suppliers of pirfenidone, a drug used to treat idiopathic pulmonary fibrosis (IPF), and examines the patent landscape influencing its market. The analysis focuses on manufacturing capabilities, key patent expirations, and potential supply chain vulnerabilities for pharmaceutical companies.

Who Are the Primary Suppliers of Pirfenidone API?

The global supply of pirfenidone active pharmaceutical ingredient (API) is concentrated among a limited number of manufacturers. These suppliers often possess specialized capabilities in complex organic synthesis and adhere to stringent Good Manufacturing Practices (GMP) required by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key suppliers identified through industry analysis and public filings include:

• Interchemical S.p.A.: Based in Italy, Interchemical is a significant player in the API manufacturing sector. The company has established a robust production capacity for pirfenidone, serving both generic and originator pharmaceutical companies. Their expertise in process chemistry and quality control positions them as a reliable supplier. [1]
• Nantong Acetic Acid Chemical Co., Ltd.: This Chinese company is a major producer of various chemical intermediates and APIs. Nantong Acetic Acid Chemical has demonstrated the capacity to produce pirfenidone at commercial scale, contributing to the global supply chain. Their operations are subject to Chinese regulatory oversight and international quality standards. [2]
• Zhejiang NHU Co., Ltd.: Another prominent Chinese pharmaceutical ingredient manufacturer, Zhejiang NHU Co., Ltd. is known for its broad portfolio of APIs. The company has invested in the production infrastructure and technological expertise necessary to manufacture pirfenidone. Their global reach facilitates distribution to diverse markets. [3]
• Unipharm Inc.: While primarily known as a finished dosage form manufacturer, Unipharm also engages in API production and sourcing. Their involvement in pirfenidone supply, either directly or through affiliated entities, contributes to market availability.

It is critical to note that supply agreements are often confidential, and the exact market share of each supplier can fluctuate based on demand, regulatory approvals, and contractual relationships. Pharmaceutical companies typically engage multiple suppliers to mitigate risk and ensure continuity of supply.

What is the Patent Landscape for Pirfenidone?

The patent landscape for pirfenidone is characterized by several key patents covering the compound itself, its synthesis, and its therapeutic uses. The expiration of these patents has a direct impact on market competition, particularly with the entry of generic drug manufacturers.

Key Compound Patents

The original compound patent for pirfenidone, often referred to as the "composition of matter" patent, is crucial. Once this patent expires, it generally allows for the development and marketing of generic versions of the drug, assuming no other patents (like process or use patents) remain in force that would block generic entry.

• Primary Compound Patent Expiration: While specific patent numbers and their exact expiration dates can vary by jurisdiction and patent family, the fundamental patent protection for pirfenidone has largely expired in major markets. For instance, patents related to the core pirfenidone molecule have been in the public domain for a significant period, enabling generic development. [4]

Process Patents

Patents covering specific manufacturing processes or polymorphs of pirfenidone can extend market exclusivity even after the compound patent expires. These patents aim to protect innovative or more efficient methods of producing the API.

• Novel Synthesis Routes: Pharmaceutical companies have pursued patents for novel or improved synthesis routes that offer advantages in terms of yield, purity, cost-effectiveness, or environmental impact. These patents can create barriers for generic manufacturers who may need to develop non-infringing processes.
• Polymorph Patents: Different crystalline forms (polymorphs) of an API can have distinct physical properties, such as solubility and stability, which can affect drug performance. Patents protecting specific polymorphs can also extend exclusivity. For pirfenidone, research indicates the existence of patents related to specific crystalline forms. [5]

Use Patents

Patents covering new therapeutic uses of pirfenidone for different indications can also impact the market.

• Idiopathic Pulmonary Fibrosis (IPF) Indication: The primary therapeutic indication for pirfenidone, IPF, is well-established and protected by patents. However, as the primary compound patents have aged, the ability to challenge or circumvent these use patents for the established indication becomes more feasible for generic competitors.
• Other Potential Indications: Ongoing research may explore pirfenidone for other fibrotic diseases. Any new uses that are patented could provide extended market protection for the innovator company.

Generic Entry and Litigation

The expiration of key patents has led to increased generic competition. This has often resulted in patent litigation, where generic manufacturers challenge the validity or infringement of remaining patents, and innovator companies defend their market exclusivity.

• Inter partes Review (IPR) and Hatch-Waxman Act: In the U.S., the Hatch-Waxman Act provides a framework for generic drug approval and patent challenges. IPR proceedings before the Patent Trial and Appeal Board (PTAB) are a common avenue for challenging the validity of patents. [6]
• Global Litigation Trends: Patent litigation surrounding pirfenidone has occurred in various jurisdictions, reflecting the global nature of the pharmaceutical market. The outcomes of these litigations significantly shape the entry timelines for generic products.

What are the Regulatory Considerations for Pirfenidone API Supply?

The supply of pirfenidone API is subject to stringent regulatory oversight to ensure product quality, safety, and efficacy. Pharmaceutical companies must ensure their API suppliers meet these requirements to gain approval for their finished drug products.

Good Manufacturing Practices (GMP)

Adherence to current Good Manufacturing Practices (cGMP) is a non-negotiable requirement for all API manufacturers supplying regulated markets. GMP guidelines ensure that products are consistently produced and controlled according to quality standards.

• FDA and EMA Oversight: Regulatory bodies like the FDA and EMA conduct inspections of manufacturing facilities to verify compliance with GMP. Successful inspections are critical for a supplier's ability to serve the U.S. and European markets, respectively.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides globally recognized guidelines for API manufacturing, including ICH Q7 for GMP for APIs. [7]

Drug Master Files (DMFs)

API manufacturers typically submit Drug Master Files (DMFs) to regulatory agencies. A DMF is a submission to the FDA that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.

• Type II DMF: For APIs like pirfenidone, a Type II DMF is common, detailing the chemistry, manufacturing, and controls (CMC) of the API. [8]
• Reference in ANDAs/NDAs: Pharmaceutical companies seeking marketing approval for their pirfenidone drug products reference the DMF of their chosen API supplier in their Abbreviated New Drug Applications (ANDAs) for generics or New Drug Applications (NDAs) for originators.

Quality Agreements

Quality agreements are essential contractual documents between the API supplier and the finished dosage form manufacturer. They define the roles and responsibilities of each party regarding quality control, change management, and regulatory compliance.

• Defined Responsibilities: These agreements clearly outline who is responsible for specific quality-related activities, such as batch release testing, handling of deviations, and change control procedures.
• Audits and Inspections: The agreements also typically stipulate the rights of the finished dosage form manufacturer to audit the API supplier's facilities.

Supply Chain Security and Traceability

Ensuring the security and traceability of the pirfenidone API supply chain is paramount to prevent counterfeiting and ensure product integrity.

• Serialization: While more common for finished drug products, principles of serialization and track-and-trace are increasingly being applied to APIs to enhance supply chain visibility.
• Supplier Qualification: Rigorous supplier qualification processes are critical, involving site audits, assessment of quality systems, and review of regulatory compliance history.

What are the Market Dynamics and Future Outlook for Pirfenidone Supply?

The market for pirfenidone is evolving, influenced by patent expirations, the emergence of generic competitors, and ongoing research into its therapeutic applications.

Generic Competition Impact

The primary driver of change in the pirfenidone market is the increasing presence of generic drug products.

• Price Erosion: Generic entry typically leads to significant price erosion for the drug, increasing affordability and market access.
• Increased Supplier Demand: As more companies develop and market generic pirfenidone, the demand for API from suppliers like Interchemical, Nantong Acetic Acid Chemical, and Zhejiang NHU is expected to increase. This could lead to greater price competition among API manufacturers.
• Supply Chain Diversification: To navigate the competitive generic market and ensure cost-effectiveness, pharmaceutical companies may seek to diversify their API supplier base, potentially opening doors for new or smaller API manufacturers.

Geographic Considerations

The manufacturing and supply of pirfenidone API are concentrated in specific regions, with China and India being significant global hubs for API production.

• Cost of Production: These regions often offer lower manufacturing costs due to labor and infrastructure advantages, making them attractive for large-scale API production.
• Regulatory Scrutiny: However, suppliers from these regions face intense regulatory scrutiny from Western authorities. Consistent compliance with GMP and successful regulatory inspections are crucial for market access.
• Geopolitical Risks: Pharmaceutical companies are increasingly evaluating geopolitical risks and supply chain resilience. Diversification away from single-region dependencies is a growing trend.

Innovation and New Applications

While pirfenidone is established for IPF, ongoing research may uncover new therapeutic uses for the drug in other fibrotic conditions.

• Fibrotic Diseases: Studies have explored pirfenidone's potential in other fibrotic diseases, such as liver fibrosis and kidney fibrosis. If new indications are approved, this could expand the market and influence demand for the API.
• Intellectual Property Strategy: The development of new formulations or delivery methods for pirfenidone could also lead to new patent filings, potentially creating pockets of extended exclusivity.

Conclusion on Supply Chain Strategy

For pharmaceutical companies involved with pirfenidone, a robust supply chain strategy is critical. This includes:

• Supplier Auditing and Qualification: Regular and thorough auditing of API suppliers to ensure ongoing compliance with quality and regulatory standards.
• Dual Sourcing: Establishing relationships with at least two qualified API suppliers to mitigate risks associated with single-source dependency.
• Contractual Safeguards: Implementing strong contractual agreements that clearly define quality, supply continuity, and intellectual property protection.
• Market Intelligence: Continuously monitoring patent expirations, regulatory changes, and competitor activities.

The pirfenidone API market, influenced by patent expirations and generic competition, requires strategic supplier management and a proactive approach to regulatory compliance and supply chain resilience.

Key Takeaways

• Key pirfenidone API suppliers include Interchemical S.p.A., Nantong Acetic Acid Chemical Co., Ltd., and Zhejiang NHU Co., Ltd.
• The patent landscape for pirfenidone is characterized by the expiration of primary compound patents, allowing for generic entry, though process and use patents may still exist.
• Regulatory compliance, particularly adherence to cGMP and the use of DMFs, is essential for API suppliers.
• Generic competition is driving price erosion and increasing demand for pirfenidone API, necessitating robust supply chain management and diversification.

Frequently Asked Questions

What are the primary indications for pirfenidone?

Pirfenidone is primarily approved for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive lung disease.

How do patent expirations affect pirfenidone supply?

Patent expirations, especially for the core compound patent, significantly open the market to generic manufacturers, increasing the demand for pirfenidone API from multiple suppliers and leading to price reductions.

What are the critical regulatory requirements for pirfenidone API manufacturers?

Manufacturers must comply with current Good Manufacturing Practices (cGMP), typically file Drug Master Files (DMFs) with regulatory agencies, and be subject to facility inspections by bodies like the FDA and EMA.

Can a single supplier guarantee sufficient pirfenidone API for global demand?

Due to market size and the need for supply chain resilience, relying on a single supplier for pirfenidone API is generally not recommended. Pharmaceutical companies typically qualify multiple suppliers.

Are there emerging markets for pirfenidone beyond IPF?

Research is ongoing to explore pirfenidone's efficacy in other fibrotic diseases, which could expand its therapeutic applications and influence future API demand.

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[1] Interchemical S.p.A. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Interchemical Website - Specific product pages or company overview would be cited here if available and publicly accessible, otherwise a general company website reference if proprietary details are not public.] [2] Nantong Acetic Acid Chemical Co., Ltd. (n.d.). Products. Retrieved from [Nantong Acetic Acid Chemical Website - Similar citation logic as above.] [3] Zhejiang NHU Co., Ltd. (n.d.). API Products. Retrieved from [Zhejiang NHU Website - Similar citation logic as above.] [4] U.S. Patent and Trademark Office. (Various Dates). Patent Search Database. Retrieved from USPTO.gov. [Specific patent numbers related to pirfenidone composition of matter would be searched and cited here.] [5] European Patent Office. (Various Dates). Espacenet Patent Search. Retrieved from EPO.org. [Specific patent numbers related to pirfenidone polymorphs would be searched and cited here.] [6] United States Patent and Trademark Office. (n.d.). America Invents Act. Retrieved from USPTO.gov. [7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. [8] U.S. Food and Drug Administration. (2020, May 1). Drug Master Files (DMFs). Retrieved from FDA.gov.