Suppliers and packagers for generic pharmaceutical drug: DANAZOL

DANAZOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0633-02	100 CAPSULE in 1 BOTTLE (0555-0633-02)	1998-06-25
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0634-02	100 CAPSULE in 1 BOTTLE (0555-0634-02)	1998-06-25
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0635-02	100 CAPSULE in 1 BOTTLE (0555-0635-02)	1996-08-09

Suppliers for the Pharmaceutical Drug: Danazol

Last updated: July 27, 2025

Introduction

Danazol is a synthetic androgen used primarily to treat endometriosis, hereditary angioedema, and certain breast cancer cases. Its unique pharmacological profile has made it a specialized therapeutic option, yet the global supply chain is characterized by a limited pool of manufacturers. This article examines the landscape of danazol suppliers, highlighting key players, regulatory considerations, manufacturing trends, and strategic factors impacting availability.

Overview of Danazol

Developed in the 1960s, danazol acts by inhibiting the mid-cycle surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in a hypoestrogenic environment. It exhibits weak androgenic activity, which can lead to androgenic side effects such as weight gain, acne, and hirsutism. Despite its efficacy, the drug's supply chain is relatively niche due to manufacturing complexities and regulatory restrictions.

Global Manufacturing and Key Suppliers

Major Manufacturers and Market Participants

1. Sanofi-Aventis (France)

   • Historically one of the primary suppliers of danazol.
   • Markets include Europe, Asia, and select territories via licensing agreements.
   • Sanofi's manufacturing facilities have historically maintained compliance with international Good Manufacturing Practices (GMP), ensuring high-quality production standards.

2. AbbVie (United States)

   • Entered the danazol market through licensing and development of generic versions.
   • Focuses on complex steroids and hormonal therapies, leveraging advanced synthetic capabilities.
   • Supplies are primarily directed towards North American and European markets.

3. Mitsubishi Tanabe Pharma Corporation (Japan)

   • Offers a range of hormonal drugs, including danazol.
   • Emphasizes high-precision synthesis and quality control.
   • Serves Asian markets extensively, often through local distribution channels.

4. Famar pharmaceutical services (Greece)

   • Acts primarily as a contract manufacturer (CMO) producing hormonal drugs, including danazol.
   • Supplies both generic and branded formulations to European markets.

5. Generic Manufacturers (India and China)

   • Several small-scale pharmaceutical companies produce generic danazol, often under contract manufacturing agreements.
   • Companies such as Zydus Cadila, Sun Pharmaceutical Industries, and Dr. Reddy’s Laboratories are active players.
   • These firms typically focus on markets with less stringent regulatory barriers, such as India and Latin America.

Emerging and Niche Suppliers

• Intas Pharmaceuticals (India): Produces generic danazol; supplies primarily Asian markets.
• Cadila Healthcare: Another Indian firm providing generic formulations, leveraging cost-effective manufacturing.
• Hikma Pharmaceuticals (UK): Known for producing hormonal drugs, including danazol, primarily for European markets.

Regulatory Landscape and Supplier Entry Barriers

Manufacturing danazol involves complex synthetic processes that require specialized facilities capable of handling potent compounds and controlling stereochemistry. Strict regulatory standards imposed by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others create high entry barriers for new players.

Additionally, the waning demand in some regions due to the availability of newer therapies, such as GnRH analogs, has limited the incentive for new entrants to invest in large-scale production. As a result, the supplier landscape remains concentrated among established, often multinational, manufacturers.

Manufacturing Trends and Challenges

• Synthetic Complexity: Danazol synthesis involves multiple steps with stereoselectivity, requiring specialized chemistry expertise and controlled environments.
• Regulatory Compliance: Maintaining GMP compliance is essential; any lapse can lead to supply disruptions.
• Patent and Market Exclusivity: Although many patents have expired, regulatory exclusivities and brand protections in certain territories influence procurement.
• Supply Chain Risks: Dependence on specific manufacturing facilities, geopolitical factors, and raw material availability impact supply stability.

Supply Chain Dynamics and Market Considerations

The relatively narrow supplier base makes the danazol supply chain vulnerable to disruptions. The recent trend toward simplified manufacturing processes and licensing agreements has eased some supply constraints but has not significantly diversified the supplier pool.

Furthermore, alternative therapies, such as gonadotropin-releasing hormone (GnRH) agents, have supplanted danazol in many indications, reducing demand and consequently the number of active suppliers.

Future Outlook

• Potential for Generic Expansion: Indian and Chinese pharmaceutical companies continue to develop generic danazol, which could increase supply and reduce prices.
• Biotechnological Alternatives: The rise of biologics for certain indications may decrease demand, further consolidating the supplier base.
• Regulatory hurdles: New manufacturing technologies will need regulatory approval, potentially delaying market entry.

Conclusion

The supply of danazol is primarily maintained by a handful of established pharmaceutical companies, with a significant portion of global production originating from India, China, and Europe. Barriers related to complex synthesis, regulatory requirements, and market dynamics have limited diversification. As demand varies and newer therapies emerge, the landscape may evolve, but current suppliers remain focused on maintaining quality and compliance within this niche market.

---

Key Takeaways

• Major suppliers include Sanofi, AbbVie, Mitsubishi Tanabe, and Indian generic manufacturers such as Zydus Cadila and Sun Pharma.
• The complex synthesis and strict regulation limit new entrants, maintaining a concentrated supplier base.
• Supply disruptions risk exists due to manufacturing complexities and geopolitical factors.
• The future of supply depends on generic expansion in emerging markets and evolving clinical preferences.
• Companies aiming for market entry must navigate high technical and regulatory barriers, emphasizing the importance of specialized manufacturing expertise.

---

FAQs

1. Is danazol available as a generic medication?
Yes, multiple generic manufacturers, especially in India and China, produce danazol, often at lower costs compared to branded versions.

2. Which regions have the most robust supply of danazol?
European and Asian markets benefit from established manufacturers like Mitsubishi Tanabe and Indian generics, with North America primarily served via licensing arrangements.

3. Are there risks associated with sourcing danazol from emerging markets?
Potential risks include variations in quality, regulatory compliance, and the stability of supply chains. Due diligence and quality assurance are crucial.

4. Has the demand for danazol decreased, affecting its supply?
Yes, alternative drugs have replaced danazol in many indications, leading to reduced demand and limited expansion of production capacity.

5. What should companies consider before entering the danazol manufacturing market?
Candidates must evaluate synthesis complexity, regulatory pathways, existing patent landscapes, and market demand to determine strategic viability.

---

Sources:
[1] European Medicines Agency – Product information for danazol.
[2] FDA Drug Approvals and Labeling.
[3] Global Pharmaceutical Market Reports.
[4] Industry analyses on hormonal drug manufacturing.
[5] Company websites and press releases.