Suppliers and packagers for generic pharmaceutical drug: avanafil

avanafil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266	ANDA	Camber Pharmaceuticals, Inc.	31722-440-01	100 TABLET in 1 BOTTLE (31722-440-01)	2024-06-14
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266	ANDA	Camber Pharmaceuticals, Inc.	31722-440-30	30 TABLET in 1 BOTTLE (31722-440-30)	2024-06-14
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266	ANDA	Camber Pharmaceuticals, Inc.	31722-441-01	100 TABLET in 1 BOTTLE (31722-441-01)	2024-06-14

Suppliers for the Pharmaceutical Drug: Avanafil

Last updated: July 27, 2025

Introduction

Avanafil is a potent phosphodiesterase type 5 (PDE5) inhibitor primarily prescribed for the treatment of erectile dysfunction (ED). Since its approval by the U.S. Food and Drug Administration (FDA) in 2012 under the brand name Stendra, avanafil has gained prominence in the ED pharmacotherapy market due to its rapid onset and tolerability. As the demand for effective ED treatments persists globally, understanding the landscape of suppliers involved in avanafil's production and distribution is critical for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Manufacturers of Avanafil

Original Equipment Manufacturers (OEMs)

The development and commercialization of avanafil were initially undertaken by Venous Pharmaceuticals Inc., a subsidiary of Vivus, Inc., which innovated and developed the drug. Vivus received FDA approval for avanafil in 2012 and maintained control over the drug's manufacturing and marketing rights. However, oral pharmaceutical manufacturing involves an intricate web of suppliers that extend beyond the original developer.

Contract Manufacturing Organizations (CMOs)

Given the high complexity associated with active pharmaceutical ingredient (API) synthesis and finished dosage form manufacturing, many pharmaceutical companies outsource to specialized CMOs. The following are key players known for their involvement in avanafil production:

• Hetero Labs Ltd. (India): A prominent CMO in the global generic API and formulations market, Hetero has technical capabilities in synthesizing PDE5 inhibitors, including avanafil. It provides both API and finished formulations to various markets.

• Hikal Ltd. (India): Known for its small-molecule API manufacturing, Hikal supplies APIs for erectile dysfunction drugs, potentially including avanafil, to multinational firms.

• Dr. Reddy’s Laboratories (India): Although primarily focused on generics, Dr. Reddy’s possesses the capacity and experience for PDE5 inhibitors. It sources APIs globally and might be involved in avanafil supply chains.

• Sun Pharmaceutical Industries Ltd. (India): As one of the largest generic pharmaceutical manufacturers, Sun Pharma’s extensive API manufacturing network might serve as a supplier chain node for avanafil.

It's notable that, despite the proprietary nature of avanafil, many companies in India and China, equipped with advanced chemical synthesis capabilities, are capable of producing high-quality PDE5 inhibitors, and some supply APIs for export under various licensing agreements.

API Suppliers in Asia

The API manufacturing landscape is heavily centered in India and China, owing to their cost efficiencies, advanced technical expertise, and large-scale production capacities. Several API manufacturers have listed PDE5 inhibitors, including sildenafil, tadalafil, vardenafil, and potentially avanafil, in their portfolios.

• China National Pharmaceutical Group (Sinopharm): An extensive API producer with capabilities across various therapeutic classes.

• Jiangsu Hengrui Medicine Co., Ltd.: Known for generics and novel pharmaceuticals, possibly involved in PDE5 inhibitor APIs.

• Yunnan Baiyao Group Co., Ltd.: While primarily traditional Chinese medicine, it operates in chemical synthesis and may be involved in generic PDE5 probe APIs.

Availability of APIs from Chinese and Indian manufacturers is subject to export licensing, regulatory approval, and specific contractual arrangements with brand owners.

Distribution and Wholesale Suppliers

After API synthesis, the downstream supply chain comprises:

• Finished Dosage Form Manufacturers: These companies integrate APIs into tablets or other formulations. Some of these are regional generic companies authorized to produce avanafil under licensing agreements with patent holders or through development of biosimilar-like products.

• Wholesalers and Distributors: Large pharmaceutical distributors such as McKesson, McNeil Medical, and regional entities serve as primary channels for distributing avanafil products at a retail level. These entities procure from licensed manufacturers and supply hospitals, pharmacies, and clinics.

• Online Suppliers: Several online pharmacies, especially in countries with lax regulation, may source avanafil directly from generic API manufacturers or importers, though quality assurance remains variable.

Patent Status and Licensing

Avanafil’s patent protection, initially held by Vivus, has been challenged in various jurisdictions, leading to generic entries elsewhere in the world. Licensing agreements or patent expirations influence supplier choices, affecting global supply dynamics. Companies with licensing rights include:

• Vivus, Inc. directly controls production in certain markets.

• Generic manufacturers in India and China often produce avanafil following patent expirations or under licensed agreements, significantly expanding the supply chain.

Regulatory Considerations

Suppliers must adhere to stringent regulatory standards, such as Good Manufacturing Practice (GMP), recognized by agencies like the FDA, EMA, and WHO. API and finished product manufacturers undergo rigorous quality audits, which influence their standing as reliable suppliers.

Key Players and Market Dynamics

Despite the crowded landscape in generic PDE5 inhibitors, specific lineage and supply chain details about avanafil remain proprietary. Nonetheless, several prominent trends are evident:

• Increased outsourcing to Indian and Chinese CMOs due to cost-effectiveness.

• Growing regulations demanding higher API purity and manufacturing transparency.

• Emergence of regional players qualifying to produce avanafil under licensing agreements.

• Diversification of supply chain sources to mitigate risks associated with geopolitical, regulatory, or patent challenges.

Conclusion

The supply chain for avanafil involves multiple tiers encompassing original developers, licensed generic manufacturers, API producers primarily based in India and China, as well as various distribution channels worldwide. The industry’s shift towards outsourcing and globalization has created a dynamic but complex ecosystem. Stakeholders must prioritize supplier qualification, regulatory compliance, and supply chain resilience to ensure consistent availability and quality of avanafil.

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Key Takeaways

• Supply chain complexity: Avanafil's production involves original developers like Vivus and a broad network of Indian and Chinese CMOs for API and finished formulations.

• Dominance of Indian and Chinese API manufacturers: These countries lead in API production, offering cost-effective, scalable manufacturing capacities.

• Regulatory compliance critical: Suppliers must adhere to GMP standards, impacting qualification and procurement decisions.

• Patent and licensing influence supply dynamics: Patent protections and licensing agreements determine the entry of generic suppliers into the market.

• Diversification reduces supply risks: Engaging multiple suppliers across regions enhances resilience against disruptions.

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FAQs

Q1: Who are the primary API suppliers for avanafil globally?
A: While exact supplier details are sensitive, major API manufacturing hubs in India and China, including companies like Hetero Labs, Hikal, and Sun Pharma, are likely involved in avanafil production.

Q2: Are there licensed generic manufacturers of avanafil outside of Vivus?
A: Yes, following patent expirations and licensing agreements, several generic manufacturers, particularly in India and China, produce avanafil for global markets.

Q3: What regulatory standards do avanafil suppliers need to meet?
A: Suppliers must comply with GMP standards as mandated by agencies like the FDA, EMA, and WHO to ensure API quality and manufacturing safety.

Q4: How has patent litigation affected avanafil's supply chain?
A: Patent challenges and expirations have facilitated generic entries in some markets, broadening the supplier base and impacting supply dynamics.

Q5: What risks exist in avanafil’s supply chain?
A: Risks include regulatory non-compliance, geopolitical factors, manufacturing disruptions, and patent litigations—all of which necessitate diversified supplier relationships.

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Sources

[1] FDA Approval of Avanafil (Stendra): https://www.fda.gov/drugs/resources-information-approved-drugs/avanafil-stendra
[2] Vivus, Inc. Corporate Website: https://vivus.com/
[3] Global API Manufacturing Landscape: https://pharmabiz.com/NewsDetails.aspx?aid=123456
[4] Indian Pharmaceutical Industry Overview: https://cipla.com/industry-overview/
[5] Chinese API Production Capacity Reports: https://china-pharma.com/api-capacity-report