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
Genentech Inc	ESBRIET	pirfenidone	CAPSULE;ORAL	022535	NDA	Genentech, Inc.	50242-121-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) / 270 CAPSULE in 1 BOTTLE, PLASTIC	2014-10-15
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

Suppliers for the Pharmaceutical Drug: PIRFENIDONE

Last updated: July 27, 2025

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Introduction

Pirenidone, a crucial pharmaceutical agent used primarily in the treatment of idiopathic pulmonary fibrosis (IPF), has garnered significant attention due to its efficacy in slowing disease progression. As the demand for pirfenidone continues to grow globally, understanding the landscape of its suppliers becomes essential for pharmaceutical companies, healthcare providers, and investors aiming for supply chain resilience and strategic procurement. This report offers a comprehensive examination of the leading suppliers, manufacturing sources, and the global distribution channels for pirfenidone.

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Overview of Pirfenidone

Pirenidone is an orally administered antifibrotic and anti-inflammatory drug with a chemical composition that effectively inhibits collagen synthesis, fibroblast proliferation, and cytokine production—mechanisms fundamental to IPF pathology. Originally developed by Nippon Roche (now Hoffmann-La Roche), pirfenidone has been approved in several countries, including Japan, the European Union, and the United States under the brand name Esbriet.

The global market for pirfenidone is projected to expand, driven by increasing IPF diagnoses and approval of new indications. Manufacturing relies on specialized chemical synthesis and batch processing, often involving complex synthesis pathways that necessitate quality control and regulatory compliance.

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Major Suppliers and Manufacturing Sources

1. Original Developers and Patent Holders

• Hoffmann-La Roche: As the pioneer and initial patent holder, Roche remains a key player in the commercialization of pirfenidone. Though their manufacturing processes are proprietary, Roche licenses production to regional manufacturers in certain markets [1].

• Other Original Developers: Several companies engaged in early development phases, such as Cipla, Mylan, and others, have eventually licensed or developed generic versions post-patent expiry (where applicable).

2. Generic Manufacturers

Post-patent expiry in various markets, numerous pharmaceutical manufacturers have entered the space with generic pirfenidone products. These include:

• Mingxin Pharmaceutical (China): A significant producer of pirfenidone API and finished dosage forms. Their manufacturing process aligns with international GMP standards, enabling export to multiple regions.

• Zhejiang Hisun Pharmaceutical: Based in China, licenced to produce pirfenidone generics for domestic and international markets, with adherence to rigorous quality controls.

• Cipla Ltd.: An Indian pharmaceutical giant that has developed its own API manufacturing capabilities for pirfenidone, supplying both domestic and exported demand.

• Mylan (now part of Viatris): A global generic pharmaceutical manufacturer offering pirfenidone products approved in several jurisdictions [2].

3. Chinese API Suppliers

Chinese API producers dominate the pirfenidone supply chain, with dozens of smaller and larger manufacturers providing high-quality APIs at competitive prices[3]. Key points include:

• Quality Standards: Many suppliers comply with international standards such as GMP, US FDA, and EU GMP, facilitating their integration into global supply chains.
• Supply Stability: Chinese manufacturers have increased capacity post-2020, stabilizing domestic and exports demand.

4. Regional and Local Suppliers

In the European Union and North America, several regional manufacturers have obtained approvals for generic pirfenidone. These companies often source APIs from China but also develop local manufacturing capabilities for finished dosage forms:

• Sandoz (a Novartis division): Developing generic formulations with established supply chains.
• Teva Pharmaceuticals: Partnering with Chinese API producers to ensure supply continuity.

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Supply Chain and Market Dynamics

The supply of pirfenidone hinges on reliable API production, rigorous quality assurance, and regulatory approvals. As the market matures with increased biosimilar and generic entrants, supply security becomes more resilient but also more competitive.

Risks affecting supply include:

• Regulatory hurdles: Variations in manufacturing standards and approvals across countries.
• Raw material shortages: Disruptions in key starting materials can impact API output.
• Geopolitical factors: Trade tensions impacting Chinese API exports have historically affected supply chains [4].

Manufacturers are increasingly diversifying sources and expanding production capacities to mitigate such risks, with some companies investing in APIs' synthesis process improvements to ensure supply chain robustness.

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Key Market Players

Company	Headquarters	Role	Market Focus	Notes
Hoffmann-La Roche	Switzerland	Original patent holder, licensed manufacturing	Global, especially US, EU, Japan	Proprietary manufacturing, licensing in other regions
Mingxin Pharmaceutical	China	API producer	China, Asia, global export	Large API manufacturing capacity
Zhejiang Hisun Pharmaceutical	China	API production	Asia, regulated markets	GMP-certified, export license
Cipla Ltd.	India	API synthesis, generics	Global, India, emerging markets	Developed multiple formulations
Mylan (Viatris)	Netherlands/US	Generics manufacturer	Global, US, EU	Extensive API supply chain

Market Trends and Recommendations

The trend toward increased genericization and API localization suggests emerging suppliers will continue to expand. Companies seeking stability should prioritize API sources with established GMP compliance, regulatory approvals, and diversified manufacturing portfolios.

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Regulatory and Quality Considerations

Suppliers must meet regional Good Manufacturing Practices (GMP) standards to ensure drug safety and efficacy. Regulatory agencies like the US FDA, EMA, and Japan PMDA conduct rigorous inspections, which suppliers must pass to maintain market access.

Certifications to note:

• GMP compliance certificates
• US FDA prior approval for APIs
• EU GMP certification

Procurement strategies should stress compliance verification and supplier audits to minimize supply disruptions and regulatory hurdles.

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Conclusion

The landscape for pirfenidone suppliers encompasses original pharmaceutical innovators, Chinese API producers, Indian generics, and regional manufacturers meeting global regulatory standards. While Hoffmann-La Roche retains a significant share through licensing, the generic market dominance by Chinese and Indian manufacturers provides diversified and cost-effective options. Ensuring supply chain stability entails selecting suppliers with robust quality assurance, compliance certifications, and production capacity expansion plans.

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Key Takeaways

• The global supply chain for pirfenidone is primarily driven by Chinese API manufacturers, complemented by Indian and regional suppliers.
• Once patent protections expire, the market shifts toward a competitive landscape of generics, increasing supply volume and affordability.
• Suppliers' adherence to GMP standards and regulatory compliance is crucial for securing market access and minimizing risks.
• Diversification of API sources and manufacturing capacities enhances supply resilience, particularly amid geopolitical uncertainties.
• Companies should establish strategic partnerships and conduct thorough supplier audits to maintain high-quality supply chains.

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FAQs

1. Who are the main API suppliers for pirfenidone globally?
Chinese manufacturers dominate the API supply chain, with key players like Mingxin Pharmaceutical and Zhejiang Hisun Pharmaceutical. Indian companies, such as Cipla and Mylan, also produce APIs for domestic and international markets.

2. Are generic pirfenidone products as effective as branded versions?
Yes. When manufactured according to strict GMP standards and passing regulatory approvals, generic pirfenidone products are bioequivalent and therapeutically equivalent to branded versions.

3. What regulatory standards must suppliers meet to export pirfenidone?
Suppliers must adhere to regional GMP standards, obtain certifications from authorities like the US FDA, EMA, or China’s NMPA, and secure necessary regulatory approvals for their products.

4. How can supply chain disruptions be mitigated for pirfenidone?
Diversifying suppliers across regions, increasing API manufacturing capacity, maintaining stockpiles, and engaging with suppliers holding international certifications can mitigate disruptions.

5. What trends are shaping the future of pirfenidone supply?
An increase in generic manufacturing, API globalization, expansion of production capacities, and technological innovations in synthesis processes are key drivers shaping future supply stability and cost dynamics.

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References

[1] Hoffmann-La Roche Annual Reports, 2022.
[2] Mylan Product Portfolio, 2023.
[3] Chinese API Manufacturer Reports, 2022.
[4] Trade and Regulatory Guides, 2022.