Suppliers and packagers for BEYAZ

BEYAZ

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	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-4075-15	3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52)	2016-10-12
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-407-00	90 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACK	2010-10-07
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-407-03	3 BLISTER PACK in 1 PACKAGE (50419-407-03) / 1 KIT in 1 BLISTER PACK (50419-407-01)	2010-10-07
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-407-70	90 BLISTER PACK in 1 PACKAGE (50419-407-70) / 1 KIT in 1 BLISTER PACK	2010-10-07
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-407-75	12 PACKAGE in 1 CARTON (50419-407-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-407-71)	2010-10-07

BEYAZ (Drospirenone/Ethinyl Estradiol) Drug Product Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the key suppliers involved in the manufacturing and distribution of BEYAZ (drospirenone/ethinyl estradiol), a combined oral contraceptive. The analysis identifies primary raw material providers, active pharmaceutical ingredient (API) manufacturers, drug product manufacturers, and critical excipient suppliers. Understanding these supply chain components is essential for assessing potential risks, ensuring supply continuity, and identifying strategic partnership opportunities.

What are the Active Pharmaceutical Ingredients in BEYAZ?

BEYAZ contains two active pharmaceutical ingredients: drospirenone and ethinyl estradiol. Drospirenone is a synthetic progestin with anti-androgenic and antimineralocorticoid properties. Ethinyl estradiol is a synthetic estrogen.

Who Manufactures the APIs for BEYAZ?

The manufacturing of the active pharmaceutical ingredients (APIs) for BEYAZ is a critical step in the supply chain. While specific manufacturers can change due to market dynamics and contractual agreements, patent literature and industry reports indicate that these APIs are produced by specialized chemical synthesis companies.

• Drospirenone API: The synthesis of drospirenone is complex, often involving multi-step chemical processes. Companies with advanced organic synthesis capabilities are typically involved.
• Ethinyl Estradiol API: Ethinyl estradiol is a well-established synthetic steroid. Its production also requires specialized expertise in steroid chemistry.

Identifying the exact current API manufacturers requires access to proprietary supply chain information, often not publicly disclosed. However, major global API manufacturers with a strong presence in hormonal compounds are likely candidates.

What Excipients are Used in BEYAZ Formulations?

BEYAZ is formulated as an oral tablet. Excipients are inactive ingredients that facilitate the manufacturing process, improve drug stability, and enhance the drug's delivery and absorption. The specific excipients used can vary slightly between formulations and by manufacturer. Common excients in oral contraceptive tablets include:

• Fillers/Diluents: These provide bulk to the tablet.
  • Lactose Monohydrate
  • Microcrystalline Cellulose
• Disintegrants: These help the tablet break apart in the digestive tract, releasing the APIs.
  • Croscarmellose Sodium
  • Povidone
• Lubricants: These prevent the tablet formulation from sticking to manufacturing equipment.
  • Magnesium Stearate
• Colorants: These are used for identification and aesthetic purposes.
  • Iron Oxide Red (for the active tablet)
  • Titanium Dioxide (for the inactive placebo tablet)
• Coating Agents: These provide a protective layer, improve swallowability, and can mask taste.
  • Hypromellose
  • Macrogol 3350
  • Polysorbate 80
  • Talc

The precise percentages of these excipients are proprietary to the drug manufacturer.

Which Companies Supply Critical Excipients?

The global excipient market is diverse, with several large multinational corporations as key suppliers. The choice of supplier for a pharmaceutical product like BEYAZ is governed by stringent quality control, regulatory compliance (e.g., GMP standards), and consistency of supply.

• Lactose Monohydrate: Suppliers include major dairy cooperatives and specialized carbohydrate manufacturers. Examples of global players include FrieslandCampina Ingredients and Associated British Foods (ABF Ingredients).
• Microcrystalline Cellulose: DuPont (formerly FMC Corporation) is a significant global supplier through its Avicel® brand. Other manufacturers also exist.
• Croscarmellose Sodium: DuPont and Ashland are prominent suppliers of croscarmellose sodium.
• Povidone: BASF and Ashland are key global suppliers of povidone.
• Magnesium Stearate: This is widely produced. Key suppliers include major chemical distributors and manufacturers of oleochemicals. Examples include Peter Greven and Mallinckrodt Pharmaceuticals.
• Titanium Dioxide: Chemours and Venator Materials are significant producers.
• Iron Oxides: Lanxess and Cathay Industries are major suppliers of iron oxide pigments.
• Polyethylene Glycols (e.g., Macrogol 3350): Dow Chemical Company and BASF are leading producers.
• Hypromellose (HPMC): Shin-Etsu Chemical and Dow Chemical are major suppliers of HPMC.

The selection of a specific excipient supplier is often a multi-year contractual relationship, subject to rigorous qualification processes by the pharmaceutical manufacturer.

Who is the Drug Product Manufacturer for BEYAZ?

The drug product manufacturing of BEYAZ, involving the blending of APIs and excipients, tablet compression, coating, and packaging, is typically handled by the pharmaceutical company that owns the brand or by a contract manufacturing organization (CMO) on their behalf. Bayer AG is the original innovator and marketing authorization holder for BEYAZ.

• Bayer AG: As the originator of BEYAZ, Bayer likely has in-house manufacturing facilities or long-standing relationships with CMOs for the production of the finished dosage form. Bayer's global manufacturing network includes sites that specialize in oral contraceptives.

In cases of generic versions of drospirenone/ethinyl estradiol, different CMOs or generic manufacturers will be responsible for drug product manufacturing, adhering to the approved Abbreviated New Drug Application (ANDA) specifications.

What is the Role of Contract Manufacturing Organizations (CMOs)?

CMOs play a crucial role in the pharmaceutical industry, offering specialized expertise and manufacturing capacity. For a product like BEYAZ, a CMO could be involved in:

• API Synthesis: Some CMOs specialize in complex multi-step chemical synthesis for APIs.
• Drug Product Formulation and Manufacturing: This includes blending, granulation, compression, coating, and packaging of the finished tablets.
• Packaging and Labeling: Ensuring the product is packaged and labeled according to regulatory requirements for different markets.

The selection of a CMO is based on factors such as Good Manufacturing Practice (GMP) compliance, regulatory track record, capacity, specialized technology, and cost-effectiveness. Major pharmaceutical companies often diversify their manufacturing base by working with multiple CMOs to mitigate supply chain risks.

How is the Supply Chain for BEYAZ Secured?

Securing the supply chain for BEYAZ involves a multi-faceted approach by the pharmaceutical company:

• Dual Sourcing: Establishing relationships with at least two qualified suppliers for critical raw materials, APIs, and excipients reduces reliance on a single source and mitigates risks associated with supplier disruptions (e.g., quality issues, geopolitical events, natural disasters).
• Supplier Audits and Qualification: Regular audits of manufacturing facilities and quality systems of all suppliers are essential to ensure compliance with GMP and other regulatory standards.
• Inventory Management: Maintaining appropriate safety stock levels for raw materials, intermediates, and finished products buffers against short-term supply interruptions.
• Long-Term Contracts: Negotiating long-term supply agreements with key suppliers provides price stability and ensures commitment to supply volume.
• Regulatory Oversight: Continuous monitoring of regulatory changes in different regions that could impact the sourcing or manufacturing of components.
• Geographic Diversification: Sourcing materials and manufacturing from different geographical locations can reduce exposure to localized risks.
• Quality Agreements: Establishing detailed quality agreements with each supplier outlines responsibilities, quality control procedures, and change control processes.

What are the Potential Supply Chain Risks for BEYAZ?

The supply chain for BEYAZ, like any pharmaceutical product, is subject to various risks:

• Raw Material Scarcity or Quality Issues: Disruptions in the supply of key starting materials or excipients due to manufacturing problems, regulatory actions against suppliers, or geopolitical instability can halt production.
• API Manufacturing Disruptions: The complex synthesis of drospirenone and ethinyl estradiol means that any issue at an API manufacturing site (e.g., equipment failure, environmental incident, regulatory non-compliance) can lead to API shortages.
• Logistics and Transportation Issues: Delays or disruptions in global shipping, port congestion, or customs issues can impact the timely delivery of raw materials and finished products.
• Regulatory Changes: New regulations or stringent enforcement in countries where suppliers are located can impact their ability to produce or export materials.
• Geopolitical Instability: Conflicts or trade disputes in regions where key suppliers operate can disrupt manufacturing and logistics.
• Intellectual Property Challenges: While BEYAZ is an established product, ongoing patent litigation or the emergence of new generic competitors can influence manufacturing and market dynamics.
• Counterfeiting: The risk of counterfeit products entering the supply chain, particularly in regions with weaker regulatory oversight, necessitates robust track-and-trace systems.

Key Takeaways

• BEYAZ relies on two primary APIs: drospirenone and ethinyl estradiol, requiring specialized chemical synthesis.
• A range of standard pharmaceutical excipients, including fillers, disintegrants, lubricants, colorants, and coating agents, are utilized.
• Global chemical and ingredient manufacturers are key suppliers of these excipients.
• Bayer AG is the originator and primary drug product manufacturer, though Contract Manufacturing Organizations (CMOs) may be involved in API synthesis or finished product manufacturing.
• Supply chain security is maintained through dual sourcing, rigorous supplier qualification, inventory management, and long-term contracts.
• Potential risks include raw material scarcity, API manufacturing disruptions, logistics challenges, and geopolitical instability.

FAQs

1. How does Bayer ensure the quality of its API suppliers for BEYAZ?

Bayer employs a stringent supplier qualification program that includes thorough audits of manufacturing facilities, quality management systems, and analytical testing capabilities. They also establish detailed quality agreements outlining specifications, testing protocols, and change control procedures.

2. Are there alternative suppliers for drospirenone and ethinyl estradiol APIs?

While specific supplier contracts are proprietary, pharmaceutical companies typically aim to qualify multiple suppliers for critical APIs to ensure supply continuity and mitigate risks. The availability of alternative suppliers depends on their technical capability, regulatory approval, and capacity to meet stringent pharmaceutical standards.

3. What measures are in place to prevent counterfeit BEYAZ from entering the supply chain?

Counterfeit prevention typically involves implementing serialization and track-and-trace systems, using tamper-evident packaging, and working closely with regulatory authorities and supply chain partners to identify and report suspicious products.

4. How do global shipping disruptions impact the BEYAZ supply chain?

Global shipping disruptions can lead to delays in the delivery of raw materials to manufacturing sites and finished products to distribution centers. This necessitates maintaining higher inventory levels and potentially utilizing alternative, albeit sometimes more expensive, logistics routes.

5. What is the typical lead time for sourcing critical excipients for BEYAZ?

The lead time for sourcing critical excipients can range from several weeks to several months, depending on the specific excipient, the supplier's production schedule, and the required order volume. This long lead time emphasizes the importance of proactive procurement and inventory management.

Citations

[1] Bayer AG. (n.d.). BEYAZ Product Information. Retrieved from [Manufacturer's official website or publicly available product insert information – Note: Specific URL not provided as it's dynamic and specific to region/language.]

[2] Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from FDA website.

[3] United States Pharmacopeia. (n.d.). USP-NF (United States Pharmacopeia–National Formulary). Retrieved from USP website.

[4] Industry reports and market analysis from pharmaceutical supply chain consultants (e.g., IQVIA, GlobalData – Note: Specific reports are proprietary and not cited here.)

[5] Patent databases (e.g., Google Patents, Espacenet) for information related to the synthesis and formulation of drospirenone and ethinyl estradiol.