Suppliers and packagers for YASMIN

YASMIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098	NDA AUTHORIZED GENERIC	TEVA PHARMACEUTICALS USA, INC.	0555-9131-67	3 BLISTER PACK in 1 PACKAGE (0555-9131-67) / 1 KIT in 1 BLISTER PACK (0555-9131-79)	2001-06-11
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-402-03	3 BLISTER PACK in 1 PACKAGE (50419-402-03) / 1 KIT in 1 BLISTER PACK	2001-05-11

Suppliers for the Pharmaceutical Drug: YASMIN

Last updated: July 30, 2025

Introduction

YASMIN is a combined oral contraceptive containing drospirenone and ethinyl estradiol, marketed primarily for birth control and hormonal regulation. Since its inception, YASMIN has been a popular choice for women worldwide, owing to its efficacy and added health benefits. The drug is produced by Bayer Pharmaceuticals and closely monitored for quality and safety standards across global markets. Understanding the landscape of suppliers involved in the manufacturing, sourcing, and distribution of YASMIN is vital for stakeholders, including healthcare providers, investors, and regulatory bodies aiming to assess supply chain stability, regulatory compliance, and market strategy.

Manufacturing and Primary Suppliers

Bayer Pharmaceuticals:

Bayer AG, a German multinational, is the primary manufacturer of YASMIN. The company owns the patent and oversees the entire production process, including raw material sourcing, formulation, and packaging. Bayer’s manufacturing facilities are located globally, with major operations in Germany, the United States, and several Asian countries. The company maintains strict compliance with Good Manufacturing Practices (GMP) standards to ensure product quality and regulatory approval across jurisdictions.

Active Pharmaceutical Ingredient (API) Suppliers:

YASMIN’s formulation hinges on two active ingredients: drospirenone and ethinyl estradiol. The supply chain for these APIs is complex, involving several specialized chemical manufacturing firms.

• Drospirenone: Bayer historically sourced drospirenone from dedicated licensors and manufacturing partners specializing in progestins. Notable suppliers include agencies like Teva Pharmaceutical Industries and other licensed chemical manufacturers in India and China, which provide bulk API following licensure agreements.

• Ethinyl Estradiol: This synthetic estrogen is produced by multiple global API manufacturers, including manufacturers in India (e.g., Cipla, Mylan), China, and Europe, which supply pharmaceutical-grade ethinyl estradiol conforming to international quality standards. These suppliers are approved and audited by Bayer to ensure consistency and safety.

Raw Material and Ingredient Suppliers

Apart from APIs, excipients, binders, and stabilizers used during formulation are supplied by vendors specializing in pharmaceutical-grade raw materials. These include pharmaceutical sugars, fillers, and coating agents sourced from trusted global suppliers compliant with pharmacopeia standards. The integrity of these raw materials is critical to maintaining YASMIN’s efficacy and shelf stability.

Distribution and Logistics Partners

YASMIN’s global distribution relies on complex logistics networks involving third-party distributors and wholesalers. Manufacturers such as Bayer coordinate with regional distribution partners to ensure timely delivery to pharmacies, hospitals, and healthcare providers. Key distribution partners include multinational logistics companies like DHL, FedEx, and customs clearance agents in various markets to navigate regulatory complexities.

Regulatory and Patent-Related Suppliers

Suppliers of regulatory data, clinical trial services, and patent management firms play a vital role in ensuring ongoing market access. Bayer’s legal and regulatory teams work closely with third-party consultants and local authorities for continuous compliance and patent protection, especially in markets with patent expirations and biosimilar competition.

Market-Specific Suppliers and Challenges

In emerging markets, local pharmaceutical manufacturers often engage in licensing agreements or contract manufacturing to produce generic versions of YASMIN once patents expire or are challenged. For instance, India’s Mylan and Cipla have marketed generic formulations of drospirenone-ethinyl estradiol-based contraceptives, often sourcing APIs from Chinese or Indian suppliers. This creates a dynamic supplier landscape influenced by patent laws, regulatory approvals, and market demand.

Supply Chain Risks and Management Strategies

The global supply chain for YASMIN faces several risks including geopolitical tensions, raw material shortages, regulatory changes, and manufacturing disruptions (e.g., due to the COVID-19 pandemic). Bayer mitigates these risks by diversifying API sources, maintaining strategic inventories, and conducting rigorous supplier audits. Alternative sourcing and technological investments in quality control also secure supply continuity.

Regulatory Approval and Quality Compliance

Suppliers involved in API and excipient production must comply with strict international standards such as GMP, ISO certifications, and local regulatory demands (e.g., FDA approval in the U.S., EMA in Europe). Regular supplier audits and batch testing are essential components of Bayer’s quality assurance processes.

Conclusion

The supply of YASMIN involves a sophisticated network comprising Bayer’s manufacturing facilities, multiple API suppliers, excipient providers, and third-party logistics companies. While Bayer maintains control over the core manufacturing process, its reliance on global suppliers for raw materials requires ongoing management and risk mitigation strategies to ensure uninterrupted availability of this widely used contraceptive. As patent protections evolve and generics proliferate, the supplier landscape continues to diversify, emphasizing the importance of regulatory compliance and supply chain resilience.

Key Takeaways

• Bayer Pharmaceuticals is the primary producer and oversees the manufacturing of YASMIN, leveraging global facilities and stringent quality standards.
• API suppliers for drospirenone and ethinyl estradiol are key components, sourced from licensed manufacturers in India, China, and Europe.
• The supply chain's complexity necessitates robust risk management, including supplier diversification and strategic inventory holdings.
• OEM and licensing agreements significantly influence the supplier landscape, especially with patent expirations leading to generic competition.
• Regulatory compliance, quality assurance, and supply chain transparency are critical factors ensuring YASMIN’s global availability.

FAQs

Q1: Who are the main suppliers of drospirenone for YASMIN?

Main suppliers include licensed API manufacturers such as Teva Pharmaceutical Industries and other specialized chemical firms in India and China, adhering to Bayer’s quality standards.

Q2: How does Bayer ensure quality control across its supply chain?

Bayer conducts regular audits, batch testing, and enforces strict GMP compliance among all API and excipient suppliers to maintain consistent product quality.

Q3: Are there regional differences in YASMIN’s supply chain?

Yes, regional variations exist, especially in emerging markets where local manufacturers may produce generic versions under licensing agreements, relying on different API sources.

Q4: What risks threaten the supply chain of YASMIN?

Potential risks include geopolitical instability, raw material shortages, manufacturing disruptions, regulatory changes, and global logistics challenges, which Bayer actively manages through diversification and contingency planning.

Q5: How do patent expirations impact YASMIN’s supplier ecosystem?

Patent expirations allow generic manufacturers to enter the market, often sourcing APIs from the same suppliers but also increasing competition and supply chain complexity in certain regions.

Sources:

1. Bayer AG official website, product information.
2. Pharmaceutical APIs supplier directories and industry reports.
3. Market analysis reports on generic drug manufacturing in India and China.
4. Regulatory guidelines from FDA, EMA, and local authorities.