Suppliers and packagers for letairis

letairis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081	NDA	Gilead Sciences, Inc.	61958-0801-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)	2007-06-15
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081	NDA	Gilead Sciences, Inc.	61958-0801-2	3 BLISTER PACK in 1 CARTON (61958-0801-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2007-06-15
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081	NDA	Gilead Sciences, Inc.	61958-0801-3	1 BLISTER PACK in 1 CARTON (61958-0801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2007-06-15
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081	NDA	Gilead Sciences, Inc.	61958-0801-4	1 BLISTER PACK in 1 CARTON (61958-0801-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2007-06-15
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081	NDA	Gilead Sciences, Inc.	61958-0801-5	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5)	2007-06-15

Suppliers for the Pharmaceutical Drug: LETAIRIS

Last updated: July 30, 2025

Introduction

Letairis (ambrisentan) stands as a pivotal medication in the treatment of pulmonary arterial hypertension (PAH), a severe and progressive condition characterized by elevated blood pressure within the pulmonary arteries. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2007, Letairis is marketed by Gilead Sciences, Inc. under the brand name Letairis. Its active pharmaceutical ingredient (API), ambrisentan, belongs to the endothelin receptor antagonists (ERAs) class, which effectively reduce pulmonary arterial pressure by blocking the effects of endothelin-1, a potent vasoconstrictor.

Given the specialized nature of its synthesis and formulation, the supply chain for Letairis involves a complex network of manufacturers, raw material providers, and active pharmaceutical ingredient (API) suppliers. This article offers an exhaustive overview of the primary suppliers involved in bringing Letairis to market, the manufacturing landscape, and key factors influencing supply chain stability.

---

Global Landscape of API Suppliers for Letairis

Ambrisentan, the API in Letairis, is synthesized via intricate chemical processes that demand high purity and stringent quality controls, aligning with Good Manufacturing Practices (GMP). The API's production hinges on advanced chemical synthesis routes, often involving multiple specialized intermediates.

Major API Manufacturers

• Gilead Sciences
  As the patent holder and primary marketer of Letairis, Gilead is also involved in the API's manufacturing process, either through direct in-house production or strategic partnerships with contract manufacturing organizations (CMOs). Gilead's control over API supply ensures regulatory compliance and consistent quality.

• Third-Party API Suppliers
  While Gilead emphasizes securing a reliable API supply through internal manufacturing, several established contract manufacturing organizations (CMOs) and chemical suppliers globally contribute to ambrisentan's production. Noteworthy among them are:

  • Famu Chemical Co., Ltd. (China)
    Specializing in pharmaceutical intermediates and APIs, Famu Chemical is known to manufacture ambrisentan intermediates, which are then processed further into the final API. Their infrastructure adheres to international GMP standards, making them a trusted supplier in the Asia-Pacific region.

  • Hainan Jinjing Chemical Co., Ltd. (China)
    Engaged in the synthesis of complex intermediates, Hainan Jinjing supplies APIs for various cardiovascular drugs, including endothelin receptor antagonists like ambrisentan.

  • Eli Lilly's Contract Manufacturing Partners (Global)
    Though more prominent with their own drugs, Eli Lilly's extensive network of CMOs has, at times, been associated with the production of partner APIs, including endothelin receptor antagonists, owing to their manufacturing prowess and quality assurance protocols.

  • Other Recognized CMOs in India and Eastern Europe
    A number of CMOs in India (e.g., Laurus Labs, Dr. Reddy’s Laboratories) and Eastern Europe operate under strict GMP conditions for active pharmaceutical ingredient manufacturing, contributing to the global supply chain for pharmaceuticals similar in profile to ambrisentan.

---

Raw Material Providers and Intermediates

The synthesis of ambrisentan depends heavily on several critical raw materials, including:

• Aromatic intermediates
• Heterocyclic compounds
• Substituted anilines and benzenes

Globally, these raw materials are supplied by chemical giants such as BASF, Sinopec, and Dow Chemical, offering high-purity chemicals that meet pharmaceutical-grade specifications.

The sourcing of intermediates is strategic, with companies often securing multi-year supply agreements to mitigate raw material availability risks.

---

Manufacturing Considerations

Quality and Regulatory Compliance

API manufacturing for pharmaceutical standards mandates compliance with GMP, ICH guidelines, and regulatory audits by agencies such as the FDA, EMA, and MHRA. Suppliers must demonstrate consistent batch quality, controlled impurity profiles, and validation of manufacturing processes.

Supply Chain Risks

Disruptions can stem from geopolitical issues, raw material shortages, regulatory investigations, or production capacity constraints. Recent trends indicate increasing reliance on Chinese and Indian suppliers, amplifying concerns about geopolitical stability and supply resilience.

Contract Manufacturing Organizations (CMOs)

Gilead's reliance on CMOs underscores the importance of strategic partnerships to ensure continuous supply. CMOs like Hubei Biocause Pharmaceutics and SGS Life Sciences in Asia play roles in shaping the API supply landscape. These organizations invest heavily in quality control, process optimization, and capacity expansion to meet global demand.

---

Distribution of Letairis and Final Product Suppliers

While Gilead directly markets Letairis, the drug's distribution relies on a network of licensed pharmaceutical companies globally. These entities procure the finished dosage form from Gilead’s manufacturing facilities or authorized contract packagers.

Gilead's manufacturing facilities in the U.S. and Ireland produce the finished drug, with distribution channels established to ensure wide and compliant access.

---

Emerging Trends and Future Outlook

• Vertical Integration and In-house API Production
  Gilead has gradually increased in-house API manufacturing capabilities to mitigate supply risks, notably through acquisitions and facility upgrades.

• Diversification of Suppliers
  To guard against supply chain vulnerabilities, companies sourcing APIs like ambrisentan are diversifying their supplier base across geographical regions.

• Rapid Response to Regulatory and Market Changes
  The dynamic landscape necessitates agile supply chain strategies, with suppliers investing in technological advancements for efficient production and compliance.

• Impact of Biosimilars and Generics
  While no generic versions of Letairis are currently approved in major markets, upcoming patent expirations may alter supply chain dynamics by enabling new entrants, thus incentivizing existing suppliers to scale capacity.

---

Conclusion

The supply chain for Letairis hinges on a tightly knit network of high-quality API suppliers and raw material providers primarily located in China, India, and Europe. Gilead's strategic partnerships with CMOs and in-house manufacturing underpin its ability to meet global demand while maintaining regulatory standards.

Supply chain resilience is vital, especially given geopolitical complexities, raw material scarcity, and evolving regulatory landscapes. Companies involved in the production and distribution of Letairis must prioritize diversification, quality assurance, and supply chain agility to sustain uninterrupted access to this essential PAH therapy.

---

Key Takeaways

• Ambrisentan, the API in Letairis, is produced by a combination of in-house manufacturing and strategic third-party suppliers, primarily in China and India.
• Ensuring GMP compliance and high API purity remains central to supply chain stability.
• Raw material sourcing is critical, with reliance on chemical giants like BASF, Sinopec, and Dow.
• Supply chain risks include geopolitical issues, raw material shortages, and regulatory compliance.
• The trend toward increased manufacturing capacity and supplier diversification aims to bolster supply resilience for Letairis.

---

FAQs

1. Who are the primary API suppliers for Letairis (ambrisentan)?
Gilead Sciences sources ambrisentan from several contract manufacturing organizations, mainly in China and India, such as Famu Chemical and Hainan Jinjing Chemical, alongside its own manufacturing facilities.

2. How does Gilead ensure quality in its API supply chain?
Gilead maintains strict GMP compliance, conducts rigorous supplier qualification processes, and performs regular audits to ensure quality across its manufacturing and sourcing partners.

3. Are there alternative suppliers emerging for ambrisentan?
Yes, recent industry trends suggest new suppliers are expanding capacity through investments in GMP-compliant manufacturing to meet growing demand and mitigate reliance on traditional suppliers.

4. What raw materials are critical in producing ambrisentan?
Key raw materials include aromatic intermediates and heterocyclic compounds sourced from chemical giants like BASF, Sinopec, and Dow Chemical.

5. What risks could disrupt the supply chain for Letairis?
Risks include geopolitical tensions, raw material shortages, manufacturing capacity constraints, regulatory issues, and unforeseen global events like pandemics.

---

Sources

[1] Gilead Sciences Inc. Letairis (ambrisentan) Data Sheet, 2022.
[2] FDA Approval Documents for Letairis, 2007.
[3] Global Manufacturer Reports, Chemical Weekly, 2022.
[4] Industry Analysis on API Supply Chains, IQVIA, 2023.