Suppliers and packagers for ambrisentan

ambrisentan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	AMBRISENTAN	ambrisentan	TABLET;ORAL	210701	ANDA	Golden State Medical Supply, Inc.	51407-594-30	30 TABLET, FILM COATED in 1 BOTTLE (51407-594-30)	2022-05-19
Apotex	AMBRISENTAN	ambrisentan	TABLET;ORAL	210701	ANDA	Golden State Medical Supply, Inc.	51407-595-30	30 TABLET, FILM COATED in 1 BOTTLE (51407-595-30)	2022-05-19
Apotex	AMBRISENTAN	ambrisentan	TABLET;ORAL	210701	ANDA	Apotex Corp.	60505-4552-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)	2022-09-19

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Ambrisentan

Introduction
Ambrisentan is an oral endothelin receptor antagonist primarily indicated for the treatment of pulmonary arterial hypertension (PAH). Its targeted mechanism involves selectively blocking endothelin type A receptors, which contributes to vasodilation and reduced pulmonary vascular resistance. As a niche yet vital medication, ambrisentan's procurement relies on a network of licensed suppliers and manufacturers. This article aims to delineate the key suppliers, explore their roles within the supply chain, and analyze factors influencing drug availability and sourcing strategies.

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Overview of Ambrisentan Manufacturing and Supply
Ambrisentan was developed by Gilead Sciences, Inc., earning FDA (Food and Drug Administration) and EMA (European Medicines Agency) approval in 2007. Its patent protection, in many markets, has enabled exclusivity, but generic manufacturers have entered the space following patent expiry or through licensing agreements. The production process involves complex chemical synthesis and rigorous quality controls mandated by regulatory authorities. Multiple suppliers, including original innovators and generic manufacturers, now participate in its global distribution.

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Key Original Equipment Manufacturers and Licensed Suppliers

Gilead Sciences, Inc.
As the pioneer and original patent holder, Gilead remains a primary supplier of Ambrisentan under the commercial brand Letairis in the United States and Volibris in certain regions. The company maintains comprehensive supply chain controls, ensuring product quality, consistency, and regulatory compliance. Its manufacturing facilities are located primarily in the United States and Europe, adhering to cGMP (current Good Manufacturing Practice) standards.

MSD/Merck & Co.
In some markets, Merck/Shire has been authorized as a licensing partner for ambrisentan. This collaboration expands the reach of the medication, especially in regions where Gilead's distribution channels are limited. Licensing agreements often stipulate that Merck sources their ambrisentan from Gilead-approved facilities to maintain quality standards.

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Generic Manufacturers

Following patent expiration in select jurisdictions (notably the U.S., post-2014), generic manufacturers entered the market, increasing accessibility and lowering prices. Notably:

• Sun Pharmaceutical Industries Ltd.
  Sun Pharma has developed a biosimilar version of ambrisentan, expanding affordability and availability across emerging markets. Their manufacturing facilities in India are compliant with local regulatory standards, with some seeking approval in global markets.

• Teva Pharmaceuticals
  Teva has obtained manufacturing rights for ambrisentan in multiple territories, producing generic formulations that meet international pharmacopoeia standards.

• Mylan (now part of Viatris)
  Viatris/Mylan supplies generic ambrisentan, leveraging their extensive global manufacturing network. Their products often serve markets with limited access to brand-name drugs.

• Others
  Various regional or local manufacturers have entered the market, especially in Asia and South America, via licensing agreements or through importing licensed generic versions.

Note: The landscape of suppliers is dynamic, influenced by patent statuses, regional regulatory approvals, and commercial strategies.

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Regulatory and Quality Considerations

Supplying ambrisentan requires strict adherence to regulatory standards. Manufacturers must register their products with agencies like the FDA, EMA, or other national authorities. Quality assurance measures include validated manufacturing processes, comprehensive stability testing, and rigorous analytical characterization to ensure bioequivalence (for generics) and consistent potency.

Many suppliers obtain certification through International Organization for Standardization (ISO), WHO prequalification, or respective local accreditation schemes. This ensures that the raw materials—often specialized chemicals—are sourced from qualified suppliers, influencing overall supply stability.

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Supply Chain Dynamics and Challenges

Manufacturing Complexity:
Ambrisentan's synthesis involves multi-step chemical processes requiring specialized equipment and expertise. Limited manufacturing capacity can constrain supply, especially during surges in demand.

Raw Material Availability:
Securing high-quality starting materials is critical. Global shortages of key chemicals can disrupt production timelines, impacting drug availability.

Regulatory Approvals:
Gaining approval for generic versions entails substantial regulatory compliance, which can delay market entry and supply stability.

Patent and Licensing Landscape:
Patent protections influence supplier entry; patent expiry opens avenues for generics to market. Licensing agreements can be a bottleneck or facilitator, depending on regional negotiations.

Market Demand & Distribution:
Drug demand varies, influenced by regional disease prevalence, healthcare infrastructure, and affordability. Suppliers often prioritize high-demand markets, leading to variability in supply availability elsewhere.

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Emerging Trends and Future Outlook

Biosimilars and Innovative Delivery:
While ambrisentan is a small molecule, ongoing research into alternative formulations or combination therapies could influence future manufacturing and supply strategies.

Global Production Expansion:
Emerging market manufacturers continue to develop capacity, aiming to diversify supply sources and mitigate geopolitical or logistical risks.

Regulatory Harmonization & Approvals:
Streamlined approval pathways in regions like Asia and Latin America could accelerate market entry for new suppliers, boosting supply diversity.

Traceability & Quality Trends:
Digital supply chain tracking enhances transparency, improving quality control and reducing counterfeit risks.

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Conclusion
The supply landscape for ambrisentan comprises a mixture of original patent-holders, licensing partners, and a growing number of generic manufacturers. Ensuring resilient supply chains depends on maintaining high manufacturing standards, regulatory compliance, and strategic licensing agreements. As demand grows and patent landscapes evolve, market dynamics will likely diversify further, emphasizing supply chain agility and quality assurance as critical factors in the availability of ambrisentan worldwide.

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Key Takeaways

• Major Suppliers: Gilead remains the primary producer; licensed partners like MSD expand reach; multiple generics (e.g., Sun Pharma, Teva, Viatris) increase availability post-patent expiry.
• Quality and Regulation: Strict adherence to cGMP, regional approvals, and international standards underpin supplier credibility.
• Supply Risks: Manufacturing complexity, raw material shortages, regulatory delays, and patent constraints pose ongoing challenges.
• Market Expansion: Emerging manufacturers and regulatory harmonization aim to diversify supply sources, enhance access.
• Future Trends: Biosimilars, digital traceability, and international collaborations will shape the future supply chain landscape.

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FAQs

1. Who are the leading global suppliers of ambrisentan?
   Gilead Sciences is the original manufacturer, with licensed partners in certain regions. Several generic manufacturers—including Sun Pharma, Teva, and Viatris—produce ambrisentan following patent expirations, expanding global access.

2. What factors influence the availability of ambrisentan in different markets?
   Patent status, regulatory approvals, manufacturing capacity, raw material access, and regional demand significantly influence supply availability across geographies.

3. Are there quality concerns associated with generic ambrisentan?
   Generics produced by reputable manufacturers that adhere to stringent cGMP standards generally meet quality expectations. Regulatory approval processes help ensure safety and efficacy equivalence.

4. Can suppliers modify or produce alternative formulations of ambrisentan?
   Currently, ambrisentan is primarily available in oral tablet form. While research into novel delivery methods exists, modifications require regulatory approval and manufacturing adjustments.

5. What is the impact of patent expiry on ambrisentan supply?
   Patent expiry allows generic manufacturers to produce lower-cost versions, increasing supply diversity and reducing prices, thereby improving patient access globally.

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References
[1] Gilead Sciences. (2007). Letairis (Ambrisentan) Prescribing Information.
[2] European Medicines Agency. (2010). Summary of Product Characteristics for Volibris.
[3] U.S. FDA. (2014). Approval of Generic Ambrisentan Post-Patent Expiry.
[4] Sun Pharmaceutical Industries. (2021). Corporate Publications.
[5] Teva Pharmaceuticals. (2022). Product Dossier and Quality Certifications.