DESOGESTREL; ETHINYL ESTRADIOL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avion Pharms	AVERI	desogestrel; ethinyl estradiol	TABLET;ORAL-21	218933	ANDA	Avion Pharmaceuticals, LLC	75854-604-01	1 BLISTER PACK in 1 CARTON (75854-604-01) / 1 KIT in 1 BLISTER PACK	2025-06-05
Avion Pharms	AVERI	desogestrel; ethinyl estradiol	TABLET;ORAL-21	218933	ANDA	Avion Pharmaceuticals, LLC	75854-604-03	3 BLISTER PACK in 1 CARTON (75854-604-03) / 1 KIT in 1 BLISTER PACK	2025-06-05
Duramed Pharms Barr	DESOGESTREL AND ETHINYL ESTRADIOL	desogestrel; ethinyl estradiol	TABLET;ORAL-21	075256	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3304-16	6 POUCH in 1 CARTON (0093-3304-16) / 1 BLISTER PACK in 1 POUCH (0093-3304-28) / 1 KIT in 1 BLISTER PACK	2017-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Desogestrel combined with Ethinyl Estradiol constitutes a commonly prescribed oral contraceptive, widely used for birth control and hormonal regulation. Its global demand necessitates a robust supply chain involving numerous reputable pharmaceutical manufacturers. Understanding the landscape of primary suppliers is crucial for healthcare providers, investors, and regulatory agencies seeking transparency, quality assurance, and strategic sourcing.

Overview of Desogestrel and Ethinyl Estradiol

Desogestrel is a third-generation progestin with high selectivity for progesterone receptors, minimizing androgenic side effects. It’s primarily used as a component of combined oral contraceptives (COCs). Ethinyl Estradiol is a synthetic estrogen synthetic estrogen widely utilized across various hormonal therapy applications. When combined, these compounds offer effective contraception with a favorable side effect profile.

The combination’s manufacturing quality directly influences therapeutic efficacy and safety, necessitating stringent regulatory compliance and quality assurance from suppliers.

Major Global Suppliers of Desogestrel

1. Bayer AG

Market Position: Bayer is a dominant player in the global pharmaceutical market, particularly in hormonal contraceptives.

Manufacturing & Supply: Bayer produces Desogestrel as part of its portfolio of oral contraceptive formulations, such as Marvelon and Desogen, with facilities adhering to Good Manufacturing Practices (GMP).

Global Reach: Bayer’s extensive distribution network ensures broad availability. The company maintains strict quality controls aligning with international standards, including FDA and EMA compliance.

2. Sandoz (Novartis)

Market Position: A leading generics manufacturer, Sandoz supplies Desogestrel as an affordable alternative to branded formulations.

Manufacturing & Supply: Sandoz’s manufacturing facilities are certified by global regulatory agencies, ensuring high-quality generics.

Global Reach: Sandoz distributes across North America, Europe, and Asia, making its products accessible worldwide.

3. Teva Pharmaceutical Industries Ltd.

Market Position: As one of the largest generic drug manufacturers globally, Teva offers Desogestrel formulations.

Manufacturing & Supply: Teva’s compliance with GMP and extensive R&D capabilities enable it to produce high-quality API (Active Pharmaceutical Ingredient) and finished dosage forms.

Global Reach: Teva’s expansive distribution channels support supply consistency in multiple markets.

4. Zheijang Huarun Sanjiu Medical & Pharmaceutical Co., Ltd. (China)

Market Position: A prominent Chinese pharmaceutical manufacturer producing Desogestrel APIs, primarily targeting Southeast Asian and domestic markets.

Manufacturing & Supply: Their API production complies with Chinese GMP standards, with increasing adherence to international quality certifications for export.

5. Others Emerging and Regional Suppliers

Macleods Pharmaceuticals (India)
Hetero Labs (India)
Gedeon Richter (Hungary)

These companies mainly supply API or finished dosage forms within regional markets, often adhering to local regulatory standards.

Suppliers of Ethinyl Estradiol

1. Pfizer Inc.

Market Position: Pfizer is a pioneer in estrogen production, with extensive experience producing Ethinyl Estradiol.

Manufacturing & Supply: Renowned for high purity and regulatory compliance, Pfizer supplies APIs and finished pharmaceuticals globally.

2. Bursa Sebi (Turkey)

Market Position: A significant regional supplier, Bursa Sebi produces Ethinyl Estradiol for export markets, especially in Eastern Europe and Asia.

Standards: GMP compliance ensures the quality of estrogenic compounds meets international standards.

3. Sun Pharmaceutical Industries Ltd.

Market Position: As India’s leading pharmaceutical manufacturer, Sun Pharma produces Ethinyl Estradiol for domestic and international markets.

4. Teva Pharmaceuticals

In addition to Desogestrel, Teva manufactures Ethinyl Estradiol, often in combination products, leveraging their sizable production facilities.

5. Dr. Reddy’s Laboratories

Market Position: A key supplier of Ethinyl Estradiol, with a focus on high-quality APIs and affordability.

Regulatory and Quality Considerations

Manufacturers supplying Desogestrel and Ethinyl Estradiol must comply with stringent regulatory standards such as:

FDA Compliance: For US markets, GMP adherence and approval from the Food and Drug Administration ensure safety and efficacy.
EMA Standards: European medicines regulators enforce rigorous quality requirements.
ISO Certifications: ISO 9001 for quality management systems and ISO 13485 for medical devices related to delivery.

Suppliers’ ability to maintain consistent batch quality, supply chain transparency, and documentation integrity is critical.

Market Dynamics and Supply Chain Challenges

Supply Security: With a diversified supplier base, companies mitigate risks associated with geopolitical issues, manufacturing disruptions, or raw material shortages.
Pricing Pressures: The presence of multiple generics producers exerts downward pressure on API and finished product prices.
Regulatory Compliance: Strict adherence to evolving standards influences supplier selection and quality assurance strategies.

Emerging Trends

Vertical Integration: Large manufacturers increasingly control multiple stages—from API synthesis to finished dosage production—to ensure quality and supply chain resilience.
Sustainability Initiatives: Eco-friendly manufacturing practices are gaining importance among suppliers to meet sustainability standards.
Regional Production Growth: Countries like India and China remain key centers for API manufacturing, catering to global demand.

Conclusion

A diverse array of global and regional manufacturers supply Desogestrel and Ethinyl Estradiol, with key players including Bayer, Sandoz, Teva, Pfizer, and Sun Pharma. These suppliers maintain rigorous quality standards to ensure therapeutic efficacy and safety, driven by regulatory compliance and market demand. Strategic sourcing requires balancing cost, quality, regulatory adherence, and supply reliability, especially amid shifting geopolitical and economic landscapes.

Key Takeaways

Major global suppliers such as Bayer, Sandoz, and Teva predominantly supply Desogestrel and Ethinyl Estradiol, ensuring widespread availability.
Regional manufacturers in China, India, and Turkey serve local markets and contribute significantly to global supply.
Regulatory compliance, including GMP, FDA, and EMA standards, is a non-negotiable criterion for reputable suppliers.
Supply chain resilience is increasingly important, prompting diversification of suppliers and vertical integration strategies.
Emerging trends focus on sustainable practices and regional API manufacturing growth to meet global healthcare needs.

FAQs

1. What are the primary factors to consider when sourcing Desogestrel and Ethinyl Estradiol suppliers?
Quality assurance, regulatory compliance, supply chain stability, cost-effectiveness, and manufacturing capacity are crucial considerations.

2. Are there regional differences in supplier quality standards for these compounds?
Yes. While major multinationals adhere to strict international standards, regional manufacturers may follow local regulations, necessitating due diligence for global quality assurance.

3. How does regulatory approval impact supplier selection?
Suppliers with proven compliance and approval from agencies like the FDA and EMA ensure product safety, efficacy, and market acceptance.

4. What is the role of generic manufacturers in the supply of these compounds?
Generics manufacturers offer cost-effective alternatives, increasing market accessibility and supply robustness.

5. Are there any recent disruptions in the supply of Desogestrel or Ethinyl Estradiol?
Supply disruptions can occur due to raw material shortages, GMP non-compliance, or geopolitical issues; diversification mitigates these risks.

Sources:
[1] Bayer Pharmaceuticals, Official Website.
[2] Sandoz Global API Portfolio.
[3] Teva Pharmaceuticals, Product Catalogue.
[4] EMA and FDA Regulatory Guidelines.
[5] Industry Reports on API Manufacturing and Supply Chain Dynamics.

Suppliers and packagers for generic pharmaceutical drug: DESOGESTREL; ETHINYL ESTRADIOL