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Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; NORGESTREL
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ETHINYL ESTRADIOL; NORGESTREL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Duramed Pharms Barr | CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9049-58 | 6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK | 2002-07-24 |
| Duramed Pharms Barr | CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840 | ANDA | A-S Medication Solutions | 50090-2183-0 | 1 KIT in 1 KIT (50090-2183-0) | 2002-07-24 |
| Duramed Pharms Barr | CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8442-2 | 1 BLISTER PACK in 1 POUCH (68788-8442-2) / 1 KIT in 1 BLISTER PACK | 2023-05-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Ethinyl Estradiol and Norgestrel
Overview of Ethinyl Estradiol and Norgestrel
Ethinyl estradiol and norgestrel are critical components in combined oral contraceptives, widely used globally for birth control. Ethinyl estradiol, a synthetic estrogen, enhances the contraceptive efficacy of progestins like norgestrel, a synthetic progestogen. Their widespread usage necessitates a reliable and compliant supply chain from reputable manufacturers and suppliers to ensure drug safety, efficacy, and regulatory compliance.
Global Market Landscape for Ethinyl Estradiol and Norgestrel Suppliers
The global pharmaceutical supply chain for active pharmaceutical ingredients (APIs) in hormonal contraceptives comprises primarily manufacturers based in India, China, and Europe. India and China dominate the production of both ethinyl estradiol and norgestrel, owing to their extensive manufacturing infrastructure, cost advantages, and large-scale production facilities.
Major Suppliers of Ethinyl Estradiol
Indian Manufacturers
Sun Pharmaceutical Industries:
As one of India's largest pharmaceutical companies, Sun Pharma produces a broad portfolio of APIs, including ethinyl estradiol, compliant with international standards such as EMA and US-FDA regulations. They supply APIs for both domestic and global markets.
GPT Healthcare:
Specializing in hormonal APIs, GPT Healthcare manufactures high-quality ethinyl estradiol and has established a global footprint. They adhere to stringent quality standards, including ISO, US-FDA, and EU regulations.
Yunnan Baiyao Group (China):
A leading Chinese pharmaceuticals producer with diversified portfolio, Yunnan Baiyao manufactures ethinyl estradiol as part of their hormonal API offerings, exporting primarily to the Asian markets.
European and US Suppliers
While India and China dominate, some European and US-based companies supply high-purity ethinyl estradiol for specialized or regulated markets, such as Gedeon Richter (Hungary) and Albemarle (US), primarily catering to niche requirements or advanced production standards.
Major Suppliers of Norgestrel
Indian Manufacturers
Lupin Limited:
Lupin is a major producer of norgestrel, offering APIs compliant with global regulatory standards. Their manufacturing facilities emphasize quality control and environmental safety.
Hetero Labs:
Hetero is a well-known Indian API producer with extensive hormonal API production capabilities, including norgestrel. They supply formulations globally, with adherence to cGMP standards.
Aurobindo Pharma:
With numerous manufacturing sites, Aurobindo produces norgestrel APIs that meet international quality benchmarks.
Chinese and Other Asian Suppliers
Hefei Meiyaer Biological Technology:
A key Chinese API manufacturer, Hefei Meiyaer supplies norgestrel to international clients, focusing on high-volume mass production.
Suzhou Yaohe Pharmaceutical:
Specialist in hormonal APIs, including norgestrel, primarily serving the Asian and emerging markets.
European and US Suppliers
There are fewer US or European suppliers for norgestrel due to manufacturing costs. However, some niche producers and contract manufacturing organizations (CMOs) fabricate high-grade norgestrel APIs for regulated markets.
Regulatory and Quality Considerations
Suppliers must comply with Good Manufacturing Practices (GMP), and their APIs require rigorous testing and certification to meet the standards set by authorities like the FDA, EMA, or Japanese PMDA. Notably, the quality of APIs influences the safety and efficacy of the final contraceptive formulations, making supplier validation critical for pharmaceutical companies.
Key Players' Role in Supply Chain Stability
Indian Pharmaceutical Sector
India accounts for over 20% of the world's generic drug exports (as of 2021), with a robust API manufacturing sector supporting both domestic and global markets [1]. Major manufacturers like Sun Pharma, Lupin, and Aurobindo have extensive export networks and compliance frameworks critical for supply stability.
Chinese API Industry
China supplies approximately 70% of the world's hormonal APIs [2], including ethinyl estradiol and norgestrel. The scale of Chinese production, combined with rapid regulatory developments, has shifted market dynamics, emphasizing supplier due diligence.
Supply Chain Risks and Mitigation Strategies
- Regulatory Changes: Rapid reforms in China and India could impact production licenses and export capabilities.
- Quality Variability: Variations in manufacturing quality necessitate stringent supplier qualification processes.
- Raw Material Shortages: Dependence on certain raw materials can disrupt production; diversification of sources mitigates this risk.
- Logistical Challenges: Global disruptions, such as pandemics, can affect shipping and inventory levels. Strategic stockpiling and diversified sourcing reduce dependency on single suppliers.
Emerging Trends and Future Outlook
- API Localization and Vertical Integration: Major pharmaceutical companies are investing in in-house API production to reduce reliance on external suppliers, ensuring supply security.
- Regulatory Harmonization: International standards are increasingly harmonized, simplifying supplier qualification.
- Sustainable Manufacturing: Suppliers focusing on environmentally sustainable processes are gaining a competitive advantage.
Conclusion
The supply landscape for ethinyl estradiol and norgestrel is predominantly centered around Indian and Chinese manufacturers, with stringent quality and regulatory standards shaping procurement strategies. Pharmaceutical companies seeking reliable sources must prioritize supplier accreditation, consistent compliance, and geopolitical risk assessment. As demand for hormonal contraceptives remains robust, supply chain resilience will be pivotal for operational success.
Key Takeaways
- Indian and Chinese manufacturers dominate the production of ethinyl estradiol and norgestrel due to cost advantages and scale.
- Regulatory compliance (GMP, FDA, EMA) is critical when selecting suppliers to ensure safety and efficacy.
- Diversifying suppliers minimizes risks associated with geopolitical changes, quality variability, and raw material shortages.
- In-house API production and strategic partnerships are increasing as companies aim for supply security.
- Continuous monitoring of regulatory developments and supplier performance underpins supply chain resilience.
FAQs
1. What are the leading global suppliers of ethinyl estradiol?
Primarily Indian manufacturers such as Sun Pharmaceutical Industries and GPT Healthcare, along with Chinese producers like Yunnan Baiyao, dominate the market, supported by European and US companies for niche applications.
2. Which companies are major suppliers of norgestrel?
Lupin Limited, Hetero Labs, and Aurobindo Pharma from India are the primary API suppliers, complemented by Chinese firms like Hefei Meiyaer Biological Technology.
3. How do regulatory standards affect API supplier selection?
Standards like GMP, FDA, and EMA compliance guarantee API quality, crucial for final product safety, and influence supplier qualification protocols.
4. What risks are associated with sourcing these APIs from China and India?
Risks include regulatory shifts, quality inconsistencies, raw material supply disruptions, and geopolitical issues. Strategic diversification and rigorous qualification processes mitigate these challenges.
5. Are there emerging suppliers or alternative sourcing options?
Yes, some pharmaceutical companies pursue vertical integration or establish partnerships with regional producers in Southeast Asia and Europe, aiming for increased supply security and quality assurance.
Sources:
[1] Indian Pharmaceutical Industry Profile, Department of Pharmaceuticals, Government of India, 2021.
[2] Global API Market Report, IQVIA, 2022.
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