Suppliers and packagers for generic pharmaceutical drug: DROSPIRENONE

DROSPIRENONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367	NDA	Exeltis USA, Inc.	0642-7470-01	1 KIT in 1 CARTON (0642-7470-01) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK	2019-06-06
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367	NDA	Exeltis USA, Inc.	0642-7470-02	1 KIT in 1 CARTON (0642-7470-02) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK	2019-06-06

Suppliers for the Pharmaceutical Drug: DROSPIRENONE

Last updated: July 29, 2025

Introduction

Drosperinone is a synthetic, steroidal progestin frequently used as a component in combination contraceptives and for hormonal therapy. Its unique pharmacological profile makes it a key active pharmaceutical ingredient (API) in various formulations targeting birth control, hormone regulation, and treatment of related conditions. The global supply chain for drosperinone involves multiple pharmaceutical manufacturers, custom synthesis companies, and raw material suppliers. This analysis provides a comprehensive overview of current suppliers, sourcing dynamics, and strategic considerations pertinent to stakeholders in the pharmaceutical and biotech sectors.

Manufacturers of Drosperinone

While many pharmaceutical companies manufacture combination contraceptives containing drosperinone, the manufacturing of pure API is more concentrated among select chemical and pharmaceutical intermediates producers. The key suppliers can be categorized as follows:

1. Major API Producers

• Mitsubishi Tanabe Pharma Corporation
  Mitsubishi Tanabe has historically been a prominent producer of drosperinone, leveraging proprietary synthesis routes that optimize yield and purity. Their production facilities in Japan adhere to stringent global quality standards, enabling them to supply to major pharmaceutical companies worldwide.

• Bayer AG
  As a leader in hormonal contraceptive development, Bayer has integrated API manufacturing for drosperinone within its global production network. Bayer’s scale and vertical integration facilitate robust supply commitments, especially for their oral contraceptive products such as Yaz and Yasmin combinations.

• Teva Pharmaceutical Industries Ltd.
  Teva, a significant player in generic pharmaceuticals, sources or manufactures drosperinone for use in their contraceptive offerings, often sourcing from specialized chemical synthesis firms. Their global footprint assures supply chain stability, especially in emerging markets.

• Sandoz (Novartis Group)
  Sandoz produces generic versions of drospirenone-based contraceptives and has established manufacturing partnerships with companies capable of supplying high-quality API, including custom synthesis firms.

2. Contract Manufacturers and Custom Synthesis Services

Given the specialized nature of drosperinone synthesis, many pharmaceutical firms rely on contract manufacturing organizations (CMOs) and custom synthesis companies that focus on complex steroidal APIs.

• Lonza Group
  Lonza offers custom synthesis services for steroidal APIs, including drosperinone, leveraging advanced synthetic chemistry capabilities and GMP-certified facilities.

• Fareva Group
  Fareva provides contract manufacturing and API synthesis services, often producing complex steroidal compounds for pharmaceutical clients under strict regulatory standards.

• Dr. Reddy’s Laboratories
  An emerging source of steroid intermediate production, Dr. Reddy’s has invested in steroidal API manufacturing and can produce drosperinone via licensed or proprietary processes.

3. Chemical Intermediates Suppliers

The synthesis of drosperinone involves advanced steroidal intermediates; thus, suppliers of such intermediates are crucial.

• Evonik Industries
  Provides steroidal intermediates used in the multi-step synthesis process of drosperinone.

• Sigma-Aldrich/Merck Group
  Supplies specialized steroidal compounds and intermediates necessary for syntheses.

Market Dynamics and Sourcing Trends

The supply landscape for drosperinone is characterized by complexity due to its synthesis involving multi-step reactions and the requirement for high purity. The reliance on specialized chemical synthesis, coupled with strict regulatory standards, limits the number of producers capable of manufacturing at scale.

Recent trends indicate strategic alliances between API manufacturers and large pharmaceutical firms to ensure supply stability, especially given the drug's importance in women’s health. Furthermore, geopolitical factors and raw material availability influence sourcing decisions. For instance, China and India play dominant roles in steroid intermediate manufacturing, though regulatory challenges and quality considerations drive some companies to diversify sourcing to Japan, Europe, or North America.

Regulatory and Quality Considerations

GMP compliance and rigorous quality standards are prerequisites for API suppliers in this sector. Suppliers must provide comprehensive documentation, stability profiles, and purity data aligning with agencies such as the FDA and EMA. This necessity narrows the pool of qualified suppliers and influences procurement strategies.

Strategic Implications for Stakeholders

• Pharmaceutical companies should cultivate strong supplier relationships with diversified API sources to mitigate supply chain disruptions.
• Contract manufacturers can leverage proprietary synthesis technologies to gain competitive advantages.
• Investors must monitor geopolitical developments affecting steroidal API production, particularly in regions dominant in raw material synthesis.

Conclusion

The production and supply of drosperinone involve a sophisticated global ecosystem dominated by specialized manufacturers, contract synthesis firms, and intermediates suppliers. Leading pharmaceutical companies like Bayer and Teva, alongside chemical synthesis experts such as Lonza and Fareva, are central to ensuring market continuity. Staying attuned to manufacturing capabilities, regulatory standards, and geopolitical factors remains essential for stakeholders seeking a reliable supply of this vital API.

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Key Takeaways

• The primary global suppliers of drosperinone include Mitsubishi Tanabe Pharma, Bayer, Teva, and Sandoz, supported by contract manufacturing organizations like Lonza and Fareva.
• The synthesis of drosperinone requires advanced steroidal chemistry expertise, restricting production to a limited number of qualified manufacturers.
• Supply stability depends on diversification strategies, strong supplier relationships, and compliance with strict regulatory standards.
• Geopolitical and raw material supply chain influences are increasingly shaping sourcing decisions.
• Strategic partnerships and technological innovation will be pivotal in maintaining continued access to high-quality drosperinone供应.

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FAQs

1. What are the main raw materials used in the synthesis of drosperinone?
The synthesis primarily involves steroidal intermediates derived from plant-based sterols, such as diosgenin and cholesterol derivatives, which undergo multi-step chemical modifications.

2. How does regulatory compliance impact suppliers of drosperinone?
Regulatory standards like GMP are mandatory for API suppliers, dictating strict quality assurance, documentation, and testing processes to ensure safety, efficacy, and manufacturability at a commercial scale.

3. Are there any new entrants in the drosperinone supply chain?
While the market is currently concentrated among established players, emerging Asian chemical manufacturers are investing in steroidal synthesis capabilities, potentially increasing competition in the future.

4. What factors affect the pricing of drosperinone APIs?
Pricing is influenced by raw material costs, synthesis complexity, regulatory requirements, supply chain stability, and geopolitical factors affecting manufacturing regions.

5. Can biologic alternatives replace drosperimone-based contraceptives?
Currently, no direct biologic substitutes are available. Drosperinone's pharmacological profile makes it integral to hormonal contraceptive formulations, although research into alternative modalities continues.

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Sources:

1. [1] Pharmaceutical APIs: Suppliers and trends, GlobalData, 2022.
2. [2] Steroidal API Manufacturing in Asia, Asia Pharma Report, 2021.
3. [3] Regulatory Standards for Steroidal APIs, EMA and FDA guidelines, 2022.
4. [4] Market Dynamics of Hormonal Contraceptives, IQVIA, 2022.
5. [5] Contract Synthesis Capabilities for Steroid Hormones, Lonza Annual Report, 2022.