Suppliers and packagers for yaz

yaz

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	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-405-03	3 BLISTER PACK in 1 PACKAGE (50419-405-03) / 1 KIT in 1 BLISTER PACK	2006-03-16

Last updated: August 7, 2025

ppliers for the Pharmaceutical Drug: Yaz

Introduction
Yaz, a combined oral contraceptive containing 3 mg drospirenone and 20 mcg ethinyl estradiol, is manufactured primarily by Bayer Pharma AG. As a popular U.S. Food and Drug Administration (FDA)-approved hormonal contraceptive, Yaz’s supply chain extends across various stages, including active pharmaceutical ingredient (API) sourcing, formulation, and finished drug manufacturing. This document examines the key suppliers involved in Yaz's production, focusing on API procurement, excipient sourcing, and manufacturing operations, along with implications for stakeholders.

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1. Active Pharmaceutical Ingredient (API) Suppliers

Drospirenone Suppliers
Drospirenone, the progestin component of Yaz, is a synthetic hormone derived through complex chemical synthesis. Bayer Pharma AG is the sole marketed producer of drospirenone for Yaz, but the API's precursor chemicals are sourced globally.

• Bayer’s API Production: Bayer operates integrated manufacturing facilities for drospirenone, primarily situated in Germany and associated countries. The company maintains strict quality controls and regulatory standards to meet global drug approval requirements.
• External API Suppliers: While Bayer produces the API internally, raw chemical intermediates such as 2,3,4,6-tetra-O-acetyl-β-D-glucopyranose or other complex precursors might be procured from specialized chemical suppliers across Europe, Asia, and the United States. Notable chemical providers in this domain include:
  • Sachem (USA)
  • Merck KGaA (Germany)
  • Advanced Chemical Suppliers in India and China (e.g., Shandong Haili High-tech Co., Ltd., and Corbion).

Ethinyl Estradiol Suppliers
Ethinyl estradiol (EE), the estrogen component in Yaz, is produced by multiple API manufacturers.

• Market Players: Major producers include:

  • Laboratorios Betel (Spain)
  • GTL (Global Technologies Ltd.) (India)
  • Hovione (Portugal and US-based facilities)
  • Patheon (now part of Thermo Fisher Scientific)

• Supply Chain Dynamics: Given the criticality of EE’s purity and stability, manufacturers often source from multiple suppliers, ensuring supply security and regulatory compliance.

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2. Excipients and Formulation Components

Yaz’s formulation requires high-quality excipients, including fillers, binders, and disintegrants.

• Microcrystalline Cellulose: Sourced globally from companies such as FMC and JRS Pharma.
• Lactose Monohydrate: Supplied by Meggle, Pfizer, or other pharmaceutical-grade lactose producers.
• Magnesium Stearate and Corn Starch: Widely supplied by specialty chemical firms like Ashland and Affiliated/Contract manufacturers.

The selection of excipient suppliers depends on their ability to meet Good Manufacturing Practice (GMP) standards and regulatory approval.

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3. Contract Manufacturing Organizations (CMOs)

In addition to Bayer’s internal manufacturing, several contract manufacturers worldwide support Yaz’s supply chain, especially for fill-and-finish. Notable CMOs include:

• Thermo Fisher Scientific (formerly Patheon): Offers formulation, fill, and packaging services aligned with regulatory requirements.
• Catalent: Known for advanced formulations and packaging.
• Recipharm: Provides manufacturing services in Europe and India.

These partnerships expand supply capacity and ensure regulatory agility to respond to market demand fluctuations.

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4. Supply Chain Risks and Considerations

• Regulatory Review and Compliance: API and excipient suppliers must adhere to cGMP standards mandated by regulatory agencies like the FDA and EMA. Non-compliance risks supply disruptions.
• Concentration Risk: Reliance on a limited number of API suppliers can expose manufacturers to supply chain disruptions—diversification of sourcing and dual sourcing strategies mitigate this risk.
• Geopolitical Factors: Trade policies, tariffs, and geopolitical tensions can impact commodity prices and sourcing logistics, especially for Asian suppliers.

5. Strategic Sourcing Trends

• Vertical Integration: Bayer’s control over drospirenone production minimizes dependency.
• Regional Diversification: Any pharmaceutical company producing Yaz or similar products often diversify their supplier base across Europe, North America, and Asia.
• Sustainability and Quality Assurance: Suppliers are increasingly required to demonstrate sustainable practices and high-quality controls, aligning with global regulatory expectations.

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Conclusion

The supply chain for Yaz involves a combination of Bayer’s internal API production, supplemented by external suppliers for key ingredients like drospirenone and ethinyl estradiol. The global nature of these suppliers underscores the importance of supply chain resilience, regulatory compliance, and strategic partnerships. Ensuring high-quality sourcing and managing geopolitical risks are vital for uninterrupted access to this widely used contraceptive.

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Key Takeaways

• Bayer is the primary manufacturer of drospirenone used in Yaz, sourcing chemical precursors globally.
• Multiple suppliers provide ethinyl estradiol, often competing to meet quality and regulatory standards.
• Excipient sourcing is diversified across global chemical suppliers committed to GMP standards.
• Contract manufacturing organizations expand production capacity and support packaging and distribution needs.
• Supply chain risks stem from regulatory compliance, geopolitical issues, and concentration of suppliers; diversification and rigorous quality assurance mitigate these concerns.

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FAQs

Q1: Who are the main active pharmaceutical ingredient (API) suppliers for Yaz?
A1: Bayer produces drospirenone internally, sourcing chemical precursors globally. Ethinyl estradiol is supplied by several manufacturers, including Laboratorios Betel, Hovione, and GTL.

Q2: How does Bayer ensure the quality of ingredients used in Yaz?
A2: Bayer adheres to strict cGMP and regulatory standards, conducting comprehensive quality control, supplier qualification, and audit programs to ensure API and excipient quality.

Q3: Are there alternative suppliers if current sources face disruptions?
A3: Yes, manufacturers often maintain multiple suppliers for key ingredients, with diversification across regions like Europe, Asia, and North America.

Q4: Which regions dominate the supply chain for Yaz ingredients?
A4: Europe (Germany, Spain, Portugal), North America (USA), and Asia (India, China) are key hubs for API and excipient sourcing.

Q5: What are potential risks affecting the supply of Yaz?
A5: Risks include regulatory non-compliance among suppliers, geopolitical tensions, supply chain disruptions, and reliance on a limited number of API producers.

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Sources

1. Bayer Pharmaceuticals Annual Reports and Supply Chain Disclosures.
2. Public API manufacturer data (GMP certifications, product catalogs).
3. Market analyses of hormonal contraceptive supply chains.
4. Regulatory agency databases (FDA, EMA).
5. Industry reports on pharmaceutical ingredient sourcing and supply chain management.