Share This Page
Suppliers and packagers for generic pharmaceutical drug: DROSPIRENONE; ESTETROL
✉ Email this page to a colleague
DROSPIRENONE; ESTETROL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258-00 | 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) | 2021-04-16 |
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258-01 | 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) | 2021-04-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Drospirenone and Estetrol
Introduction
The pharmaceutical landscape for hormonal therapies, notably contraceptives and hormone replacement treatments, involves key active pharmaceutical ingredients (APIs) such as drospirenone and estetrol. Both compounds serve critical roles in gender-specific therapies, with drospirenone commonly used as a progestin in combination contraceptives and estetrol gaining attention as a novel estrogenic agent. Understanding the suppliers of these APIs is vital for pharmaceutical companies, healthcare providers, and investors aiming to navigate the complex supply chain dynamics, quality standards, and regulatory landscape associated with these compounds.
Overview of Drospirenone and Estetrol
Drospirenone:
A synthetic progestin with antimineralocorticoid and antiandrogenic properties, drospirenone is primarily utilized in combination oral contraceptives. It is structurally related to spironolactone and offers hormonal balance with a favorable safety profile. The molecule was first approved for medical use in the early 2000s and has since become a standard ingredient in various contraceptive formulations globally.
Estetrol:
A naturally occurring estrogen produced exclusively by the fetal liver during pregnancy, estetrol (E4) has emerged as a promising candidate for hormone therapies. Its unique profile offers reduced hepatic impact, promising safer options for hormone replacement therapy (HRT) and contraceptive products.
Global Suppliers and Manufacturing of Drospirenone
The supply of drospirenone is predominantly controlled by a few key pharmaceutical ingredient manufacturers, often integrated with upstream chemical synthesis capabilities. As of 2023, the leading suppliers include:
1. Chemo Group (Spain)
Chemo Group is a prominent player in the global API market, including drospirenone. The company has advanced synthetic capabilities for steroid hormones and has established a robust supply chain addressing North America, Europe, and Asia markets. Chemo Group emphasizes quality certification, including cGMP compliance, and offers consistent supply for branded and generic pharmaceutical firms.
2. Hetero Labs (India)
Hetero operates one of the largest steroid API manufacturing facilities in India. Its extensive portfolio includes drospirenone, with production facilities adhering to stringent international quality standards. Hetero has secured long-term supply agreements with pharmaceutical companies across the world, capitalizing on its cost advantage and large-scale manufacturing.
3. Dr. Reddy’s Laboratories (India)
Dr. Reddy's manufactures drospirenone as part of its steroid API portfolio. The company boasts strong R&D capabilities, enabling innovative synthesis routes—improving yield, purity, and cost efficiency. Its API production complies with global regulatory standards, making it a reliable supplier for multinational pharmaceutical firms.
4. Hunan Biopharma (China)
Hunan Biopharma has expanded its API offerings to include drospirenone, emphasizing high-volume manufacturing and competitive pricing. Their facilities have achieved global GMP compliance, catering to various markets including Europe and the Americas.
Note: The market for drospirenone is also supported by licensing agreements and contract manufacturing organizations (CMOs) in regions with emerging pharmaceutical industries. The supply landscape is characterized by strategic partnerships and technological collaborations to maintain high-quality standards.
Suppliers and Production of Estetrol
Estetrol's unique origin from fetal liver shifts its supply paradigm from traditional chemical synthesis to biotechnological production methods. Currently, commercialization pathways focus on biotechnology firms and specialized contract manufacturers.
1. Nurai (formerly HRA Pharma, now part of Japan's Allergan-Novartis merger)
Nurai, a pioneer in estetrol development, has established proprietary biotechnological platforms to produce estetrol through fermentation techniques. Its production pipeline emphasizes purity, scalability, and regulatory compliance, positioning Nurai as a leading supplier of pharmaceutical-grade estetrol for clinical and commercial applications.
2. Gedeon Richter (Hungary)
Gedeon Richter has engaged in research collaborations and early-phase development of estetrol-based products. While primarily a drug developer, it possesses biomanufacturing capabilities to produce estetrol at scale, focusing on HRT and contraceptive markets.
3. Biotech Firms and CMOs
A small but growing number of contract manufacturing organizations (CMOs) specializing in peptide and hormone bioproduction, primarily located in Europe, Asia, and North America, are increasingly capable of producing estetrol. These facilities utilize recombinant DNA technology to produce estetrol with high purity, adhering to regulatory standards for clinical and commercial use.
Emerging trends suggest more pharmaceutical companies are exploring biosynthetic routes of estetrol, potentially broadening supply options in the coming years as R&D progresses.
Regulatory and Quality Considerations
For pharmaceutical suppliers, compliance with Good Manufacturing Practices (GMP), validation protocols, and regulatory approvals (e.g., FDA, EMA) are critical. Established suppliers like Chemo Group, Hetero, and Dr. Reddy’s have robust certifications, ensuring consistent API quality for global markets.
In contrast, newer biotech-based estetrol manufacturers are advancing through clinical trial phases, with regulatory submissions expected to expand their market access. The unique biotechnological production of estetrol brings additional regulatory scrutiny, particularly regarding source material and fermentation processes.
Market Dynamics and Supply Chain Challenges
The supply chain for drospirenone remains relatively consolidated, with India and China serving as primary manufacturing hubs due to cost efficiencies and established infrastructure. Nonetheless, geopolitical factors, export regulations, and quality assurance continue to influence global supply stability.
For estetrol, supply chain development is ongoing. Biotechnological complexity, production costs, and the relatively limited number of manufacturers constrain rapid scaling. Future growth hinges on strategic partnerships, technological advances, and regulatory approvals.
Conclusion
The suppliers of drospirenone include leading pharmaceutical chemical producers such as Chemo Group (Spain), Hetero Labs (India), Dr. Reddy’s Laboratories (India), and Hunan Biopharma (China). They provide high-quality APIs to the global pharmaceutical industry, supported by stringent regulatory standards.
In contrast, estetrol suppliers predominantly comprise biotechnological firms leveraging recombinant DNA technology. Nurai (part of Allergan-Novartis) and Gedeon Richter lead the development and supply of pharmaceutical-grade estetrol, with an increasing number of CMOs entering the market.
Navigating this supply chain requires vigilance on quality, regulatory compliance, and geopolitical stability, vital for pharmaceutical companies planning partnerships or procurement strategies.
Key Takeaways
-
Market Concentration: Drospirenone supply is concentrated among a handful of globally recognized chemical API manufacturers, primarily in India, China, and Spain.
-
Emerging Biotech Leaders: Estetrol's biotechnological production landscape is evolving, with biotech firms leading the supply chain through advanced fermentation methods.
-
Regulatory Barriers: Compliance with international GMP standards and regulatory approvals remain critical filters for API suppliers, influencing supply stability.
-
Supply Chain Risks: Geopolitical tensions, export restrictions, and production capacity limitations pose ongoing risks, necessitating diversification strategies.
-
Future Outlook: As estrogen-based therapies expand, the demand for estetrol is expected to grow, prompting increased investment in biotech manufacturing and supply chain diversification.
FAQs
1. Who are the key global suppliers of drospirenone?
Major suppliers include Chemo Group (Spain), Hetero Labs (India), Dr. Reddy’s Laboratories (India), and Hunan Biopharma (China). These companies provide high-quality APIs adhering to international standards for global markets.
2. Is estetrol currently available commercially, and who supplies it?
Yes, estetrol is moving toward commercialization, primarily supplied by biotech firms like Nurai. The supply chain is still emerging, with additional biotechnological companies expected to enter the market as development progresses.
3. What regulatory considerations impact API suppliers for drospirenone and estetrol?
Regulatory compliance with cGMP standards, quality certifications, and regulatory approvals (FDA, EMA) influence supplier credibility. Quality assurance is vital for market access and supply stability.
4. What are the main challenges in sourcing estetrol?
Limited manufacturing capacity, high production costs due to biotechnological processes, and stringent regulatory hurdles pose challenges. Supply chain scaling depends on technological advancements and regulatory approvals.
5. How do geopolitical factors influence the supply chain of these APIs?
Trade restrictions, export controls, and political tensions can disrupt supply chains, particularly those reliant on China and India. Diversification and strategic partnerships help mitigate these risks.
References
[1] Understanding the global drospirenone market: Market Research Future.
[2] Biotech production of estetrol: Gedeon Richter official reports.
[3] Regulatory standards for steroid APIs: FDA and EMA guidelines.
[4] Industry analysis: Chemo Group annual report 2022.
[5] Recent advances in recombinant hormone manufacturing: Biotechnology Journal, 2023.
More… ↓
