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Suppliers and packagers for ETHINYL ESTRADIOL; ETONOGESTREL
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ETHINYL ESTRADIOL; ETONOGESTREL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa Inc | ETHINYL ESTRADIOL; ETONOGESTREL | ethinyl estradiol; etonogestrel | RING;VAGINAL | 204305 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7679-02 | 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01) | 2021-01-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ethinyl Estradiol; Etonogestrel
Introduction
The combination of Ethinyl Estradiol and Etonogestrel is a widely used hormonal contraceptive known for its efficacy in preventing pregnancy. This formulation, typically available as a subdermal implant or vaginal ring, involves complex manufacturing, strict regulatory standards, and a global supply chain. As demand for contraceptive options escalates alongside evolving healthcare regulations, identifying reliable suppliers becomes vital for pharmaceutical companies, healthcare providers, and investors.
This comprehensive analysis delineates the global landscape of suppliers manufacturing Ethinyl Estradiol and Etonogestrel, emphasizing key manufacturers, their manufacturing capacities, regulatory standings, and strategic positioning within the pharmaceutical supply chain.
Manufacturers of Ethinyl Estradiol and Etonogestrel
1. Global Pharmaceutical Giants
a. Bayer AG
- Role: Bayer is a leading global pharmaceutical company with longstanding expertise in contraceptive hormones. Their combined contraceptive products, including those containing Ethinyl Estradiol and Etonogestrel, are manufactured at their dedicated facilities.
- Manufacturing Capabilities: Bayer’s facilities in Germany and the United States produce active pharmaceutical ingredients (APIs) and finished dosage forms for hormonal contraceptives.
- Regulatory Standing: Bayer holds multiple regulatory approvals, including FDA and EMA authorizations, for their hormonal contraceptives, ensuring adherence to international standards.
b. Merck KGaA (Eli Lilly & Company Collaboration)
- Role: Merck manufactures Etonogestrel for various contraceptive products, including subdermal implants (e.g., Nexplanon).
- Manufacturing Capabilities: Their facilities in Germany and the United States produce APIs and finished products, with continuous investment in manufacturing capacity.
- Regulatory Standing: Merck’s products are approved globally, with strong compliance with global regulatory standards.
c. Teva Pharmaceutical Industries
- Role: Teva offers generic formulations containing Ethinyl Estradiol and Etonogestrel, supplying both APIs and finished dosage forms.
- Manufacturing Capabilities: Large-scale API production units in Israel and India.
- Regulatory Standing: Holds approvals for generic contraceptive products across numerous markets.
2. API Manufacturers Specializing in Hormonal Agents
a. Jiangsu Hengrui Medicine Co., Ltd. (China)
- Role: Hengrui produces high-quality APIs, including Ethinyl Estradiol, serving both domestic and international markets.
- Manufacturing Capabilities: Extensive API facilities with high output capacity.
- Regulatory Standing: Many products are approved for export under strict regulatory standards.
b. Zhejiang Xianju Pharmaceutical Co., Ltd.
- Role: Known for manufacturing hormonal APIs, including Ethinyl Estradiol.
- Manufacturing Capabilities: Focuses on hormonal API synthesis compliant with international standards.
c. Mylan (Now Viatris after merger) / Pfizer
- Role: Mylan, acquired by Viatris, and Pfizer supplied various contraceptive APIs.
- Manufacturing Capabilities: Broad API manufacturing infrastructure.
3. Contract Manufacturing Organizations (CMOs) and API Suppliers
a. Zhejiang Hisun Pharmaceutical Co., Ltd.
- Role: Produces APIs for hormonal contraceptives, including Ethinyl Estradiol.
- Partnerships: Supplies to global pharmaceutical firms under contract manufacturing agreements.
b. Sun Pharmaceutical Industries Ltd.
- Role: Provides generic APIs, including hormonal agents, for the international market.
- Manufacturing Capabilities: Robust API production with worldwide distribution.
c. Catalent and Patheon
- Role: Leading CMOs providing both formulation and manufacturing services, including hormonal contraceptives.
- Strategic Position: Often serve as key suppliers for brand-name and generic contraceptive products.
Supply Chain Dynamics and Market Considerations
The pharmaceutical supply chain for Ethinyl Estradiol and Etonogestrel is complex, involving multiple tiers—from raw material sourcing to formulation and packaging. API manufacturing is concentrated primarily in China and India, with significant contributions from Europe and North America. Issues such as regulatory compliance, intellectual property rights, and manufacturing capacity influence supplier selection.
Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) established by agencies such as the FDA, EMA, and China’s NMPA. Certifications impact market access, especially in highly regulated regions.
Capacity and Scalability: Modern demand for contraceptive products necessitates scalable API and finished-dose manufacturing. Suppliers investing in capacity expansion, such as Jiangsu Hengrui's recent upgrades, position themselves favorably.
Geopolitical Risks: Tariff policies, export restrictions, and geopolitical tensions, especially concerning Chinese and Indian suppliers, pose potential supply chain risks. Diversification remains crucial.
Innovations and Future Trends
Biotechnological Advances: Shifts towards bioengineered hormones might alter supplier landscapes, favoring biotech firms capable of producing recombinant hormones.
Regulatory Trends: Increasing regulatory scrutiny on manufacturing practices and ingredient sourcing may influence supplier selection, prioritizing suppliers with robust regulatory records.
Sustainability: Environmental considerations, including minimizing chemical waste and water usage, drive some suppliers to adopt greener manufacturing processes.
Conclusion
The landscape of suppliers for Ethinyl Estradiol and Etonogestrel features established pharmaceutical giants alongside specialized API manufacturers across China, India, and Europe. Leading players like Bayer, Merck, and Teva command significant manufacturing capacities and comply with stringent regulatory standards, ensuring a steady supply of high-quality products. Contract manufacturers and API suppliers from China and India augment the global supply chain, offering cost-effective options with growing regulatory oversight.
Strategic sourcing necessitates balancing cost, compliance, capacity, and geopolitical factors. As the demand for hormonal contraceptives escalates, suppliers investing in capacity expansion, technological innovation, and regulatory adherence will hold competitive advantages.
Key Takeaways
- Leading OTC contraceptive manufacturers like Bayer and Merck dominate through integrated API and finished product production.
- China and India serve as primary API manufacturing hubs, offering high-volume, cost-effective APIs, but require vigilance concerning regulatory compliance.
- Diversification in the supply chain mitigates risks associated with geopolitical tensions and regulatory changes.
- The future landscape favors suppliers adopting sustainable manufacturing and biotechnological innovations.
- Establishing robust supply agreements with trusted manufacturers ensures uninterrupted supply amid increasing global demand.
FAQs
1. Who are the main API suppliers for Ethinyl Estradiol and Etonogestrel globally?
Major API producers include Jiangsu Hengrui Medicine, Zhejiang Xianju Pharmaceutical, and Sun Pharmaceutical Industries, primarily based in China and India, with additional suppliers in Europe.
2. What regulatory standards must suppliers meet for global distribution?
Suppliers must adhere to Good Manufacturing Practices (GMP) certified by agencies like the FDA (U.S.), EMA (Europe), and NMPA (China), ensuring product quality and safety.
3. How does geopolitical risk influence supplier choices?
Regions like China and India dominate API manufacturing but pose risks due to trade restrictions and regulatory shifts. Diversification and supplier audits are crucial strategies.
4. Are there emerging suppliers or technologies influencing this market?
Yes. Biotech firms exploring recombinant hormones and greener manufacturing technologies are emerging, potentially transforming the supply chain landscape.
5. What should pharmaceutical companies consider when selecting suppliers for Ethinyl Estradiol and Etonogestrel?
They should evaluate regulatory compliance, manufacturing capacity, quality assurance, geopolitical stability, and sustainability practices.
References
[1] Bayer HealthCare. Contraceptive Portfolio. https://www.bayer.com
[2] Merck KGaA. Etonogestrel-related products. https://www.emdgroup.com
[3] Teva Pharmaceuticals. Hormonal Contraceptives. https://www.tevapharm.com
[4] China National Medical Products Administration (NMPA). API manufacturing approvals. https://www.nmpa.gov.cn
[5] Market research reports on global hormonal contraceptives and API supply chain dynamics.
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