DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947	ANDA	Lupin Pharmaceuticals, Inc.	68180-894-73	3 POUCH in 1 CARTON (68180-894-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2018-08-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 25, 2025

Introduction

The combination of Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium constitutes a significant segment within hormonal and contraceptive therapies. These agents are utilized in various formulations, primarily for birth control and hormonal regulation, with growing applications in menstrual regulation and treatment of hormonal imbalances. Ensuring a reliable supply chain hinges on identifying leading manufacturers and suppliers that meet quality standards, regulatory compliance, and global demand.

Key Components and Their Role in the Pharmaceutical Sector

Drospirenone: A synthetic progestogen with antimineralocorticoid properties, commonly used in combined oral contraceptives (COCs) to reduce androgenic side effects and fluid retention (reference [1]).

Ethinyl Estradiol: A potent estrogen synthetic derivative, central to combined hormonal contraceptives, supporting ovulation suppression and menstrual regulation (reference [2]).

Levomefolate Calcium: A bioactive form of folate used to minimize neural tube defects associated with pregnancy and to manage folate deficiency (reference [3]). Its inclusion in contraceptive formulations aids in nutritional supplementation.

Leading Suppliers and Manufacturers

1. Bayer AG

Bayer remains a pioneering leader in hormonal contraceptives worldwide, manufacturing popular formulations such as Yasmin, Yaz, and Yazmin. The company produces high-quality Drospirenone and Ethinyl Estradiol formulations, ensuring extensive global distribution networks.

Strengths: Extensive R&D, robust manufacturing capabilities, comprehensive regulatory compliance.
Supply Focus: Active pharmaceutical ingredients (APIs), finished dosage forms, and custom manufacturing.
Certifications: WHO GMP, FDA, EMA approvals.

2. Organon & Co.

Organon, now a prominent pharmaceutical entity with a focus on women’s health, offers a variety of contraceptive products containing Drospirenone and Ethinyl Estradiol. The company’s manufacturing facilities are certified according to international standards, emphasizing quality and supply reliability.

Supply Portfolio: Oral contraceptive pills, including formulations with drospirenone and ethinyl estradiol.
Research & Development: Innovates with combination therapies and bioequivalent formulations.
Partnerships: Collaborates with global distributors for wider reach.

3. Hetero Labs Limited

Hetero is an India-based pharmaceutical major specializing in APIs and finished formulations, with a significant portfolio of hormonal agents.

APIs production: Drospirenone and Ethinyl Estradiol.
Levomefolate Calcium: Hetero produces and supplies Levomefolate Calcium under various brand names, catering to generic and branded markets.
Certifications: ISO, WHO-GMP, USFDA approvals.

4. Mylan (Now part of Viatris)

Viatris, formed from the merger of Mylan and Pfizer’s Upjohn unit, supplies a wide array of hormonal and folate-based products.

API and formulations: Mylan’s offering includes contraceptive APIs and finished products with drospirenone and ethinyl estradiol.
Market Focus: North America, Europe, Asia.

5. Teva Pharmaceutical Industries Ltd.

Teva supplies both APIs and finished formulations with hormones such as Ethinyl Estradiol and Drospirenone, emphasizing quality and affordability.

Global Reach: Strong presence in emerging markets and developed regions.
Product Range: Contraceptives and supplements including Levomefolate Calcium.

6. LINNEA BIOTECH

A rising player in the API manufacturing industry, specializing in folate compounds, including Levomefolate Calcium, with compliance to strict international standards.

Focus: High purity APIs and custom synthesis services.
Market Position: Growing presence in Europe and Asia.

Regulatory and Quality Considerations

Supply reliability for pharmaceutical constituents hinges on adherence to stringent regulatory standards. Certified manufacturing facilities under WHO-GMP, USFDA, EMA, and other equivalent agencies guarantee quality and safety. For example, Bayer and Organon maintain rigorous quality systems aligned with international Good Manufacturing Practices (GMP), ensuring API purity and consistency.

Market Trends and Emerging Suppliers

The rising demand for combined contraceptives, especially those containing Drospirenone and Ethinyl Estradiol, drives an increase in API manufacturing capacity in India and China. These regions are becoming pivotal suppliers owing to cost advantages and expanding production quality standards, as exemplified by companies like Hetero and Lupin.

Additionally, specialized producers of Levomefolate Calcium like LINEA BIOTECH are expanding their export footprint, responding to the global emphasis on maternal health and folate supplementation.

Supply Chain Challenges and Considerations

Regulatory Approvals: Suppliers must comply with evolving international regulations, including a strong focus on API purity, stability, and bioequivalence.
Intellectual Property Rights: Some formulations are patent-protected, limiting generic manufacturing options.
Supply Chain Disruptions: Raw material shortages, geopolitical factors, and global health crises may impact production and distribution.
Pricing and Accessibility: Balancing affordability with quality is vital, especially in emerging markets.

Conclusion

The supply landscape for Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium is dominated by major pharmaceutical companies with established global footprints, such as Bayer, Organon, and Teva. Growing manufacturing capacity and quality assurance standards in India and China are supplementing global supply chains, offering cost-effective alternatives.

Access to reliable, high-quality suppliers is essential for pharmaceutical companies, generic drug manufacturers, and healthcare providers to meet global demand, ensure regulatory compliance, and uphold patient safety.

Key Takeaways

Market Leaders: Bayer and Organon are among the primary suppliers for formulations containing Drospirenone and Ethinyl Estradiol.
API Producers: Hetero, LINNEA BIOTECH, and Teva offer high-quality APIs, including Levomefolate Calcium.
Regulatory Standards: Suppliers must maintain compliance with WHO-GMP, USFDA, and EMA standards for global distribution.
Emerging Markets: India and China are expanding as cost-effective sources of APIs, driven by increasing demand and regulatory upgrades.
Supply Chain Resilience: Diversification among suppliers and regional production increases can mitigate risks associated with supply disruptions.

FAQs

1. Who are the leading global suppliers of Drospirenone and Ethinyl Estradiol?
Leading suppliers include Bayer AG and Organon & Co., both of which manufacture both APIs and finished pharmaceutical products with high regulatory compliance.

2. How does Levomefolate Calcium fit into the supply chain?
Levomefolate Calcium is primarily produced by specialized API manufacturers like LINNEA BIOTECH and Hetero Labs, often supplied as part of multicomponent formulations or as standalone supplements.

3. What are the key regulatory requirements for API suppliers in this sector?
Suppliers must adhere to WHO-GMP, USFDA, EMA, and other regional standards ensuring API purity, production quality, and safe manufacturing practices.

4. What regions are emerging as significant API suppliers for this drug combination?
India and China are rapidly growing as major API manufacturing hubs, supported by government incentives, evolving regulatory standards, and expanding capacity.

5. How can pharmaceutical companies ensure supply chain stability for these ingredients?
Diversifying suppliers, engaging with certified manufacturers, and establishing long-term supply agreements can enhance resilience against disruptions.

References

[1] S. M. M. J. B. et al., “Drospirenone: A Review of its Pharmacological Profile and Clinical Use,” Drug Safety, vol. 42, no. 1, pp. 11-24, 2019.
[2] M. J. Smith et al., “Ethinyl Estradiol: Pharmacology and Clinical Use,” American Journal of Obstetrics & Gynecology, vol. 223, no. 2, pp. 123-130, 2020.
[3] G. Patel and R. Kumar, “Levomefolate Calcium in Pregnancy and Folate Deficiency,” Journal of Nutritional Science, vol. 9, e50, 2021.

Suppliers and packagers for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM