Suppliers and packagers for seasonique

seasonique

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3134-82	2 POUCH in 1 CARTON (0093-3134-82) / 1 BLISTER PACK in 1 POUCH (0093-3134-91) / 1 KIT in 1 BLISTER PACK	2011-07-28

Seasonique Drug Supplier Landscape

Last updated: February 19, 2026

Key Manufacturers and Suppliers of Seasonique Active Pharmaceutical Ingredients (APIs) and Excipients

This report details the primary manufacturers and suppliers of active pharmaceutical ingredients (APIs) and critical excipients for Seasonique, a low-dose, extended-cycle oral contraceptive. Understanding the supply chain for Seasonique is crucial for assessing manufacturing continuity, potential cost fluctuations, and overall market risk for stakeholders.

Seasonique is a combination oral contraceptive containing levonorgestrel and ethinyl estradiol, with an extended-release iron supplement. Its unique formulation and extended-cycle regimen necessitate specialized manufacturing processes and a reliable supply of high-purity raw materials. The primary APIs are levonorgestrel and ethinyl estradiol, while the extended-release iron component is typically ferrous fumarate. Key excipients include fillers, binders, disintegrants, and coating agents, all requiring strict adherence to pharmacopeial standards.

Levonorgestrel API Suppliers

Levonorgestrel is a synthetic progestogen widely used in hormonal contraceptives. The production of levonorgestrel API is a complex multi-step synthesis. Key global suppliers are concentrated in regions with established chemical and pharmaceutical manufacturing infrastructure.

• Key Manufacturers:

  • Bayer AG: As the originator of Seasonique (marketed as Seasonique in the US and other regions), Bayer likely maintains internal manufacturing capabilities or has long-standing contracts with specific API suppliers. Bayer's primary API manufacturing sites are located in Germany and the United States [1].
  • Ashland Global Holdings Inc.: Ashland is a significant global supplier of specialty excipients and APIs, including levonorgestrel. Their manufacturing capabilities are distributed across North America and Europe [2].
  • IOL Chemicals and Pharmaceuticals Ltd.: This Indian-based company is a major producer of APIs, including levonorgestrel, serving global markets. Their facilities are located in Punjab, India [3].
  • Divi's Laboratories Limited: Another prominent Indian API manufacturer, Divi's Laboratories produces levonorgestrel. Their manufacturing plants are located in Andhra Pradesh, India [4].
  • Chemsol India: A manufacturer and exporter of bulk drugs and APIs, including levonorgestrel, based in India.

• Geographic Concentration: Asia, particularly India and China, along with Europe, are the primary manufacturing hubs for levonorgestrel API due to cost efficiencies and established expertise in steroid synthesis.

Ethinyl Estradiol API Suppliers

Ethinyl estradiol is a synthetic estrogen. Its manufacturing process is also specialized, with a limited number of global producers.

• Key Manufacturers:

  • Bayer AG: As with levonorgestrel, Bayer's internal capabilities or strategic partnerships are significant for ethinyl estradiol supply.
  • Amneal Pharmaceuticals: Amneal is a US-based generics manufacturer that also produces APIs. They have manufacturing capabilities in the US and India [5].
  • Dr. Reddy's Laboratories: A global pharmaceutical company with significant API manufacturing operations in India, Dr. Reddy's is a potential supplier of ethinyl estradiol. Their API facilities are located in Andhra Pradesh, India [6].
  • Sun Pharmaceutical Industries Ltd.: The largest pharmaceutical company in India, Sun Pharma has extensive API manufacturing capabilities and is a known producer of steroidal APIs, including ethinyl estradiol. Their facilities are in India [7].

• Geographic Concentration: Similar to levonorgestrel, the production of ethinyl estradiol is concentrated in India and, to a lesser extent, Europe and North America. The highly regulated nature of estrogen production places a premium on quality and compliance.

Ferrous Fumarate Suppliers

Ferrous fumarate serves as the supplemental iron source in Seasonique. It is a more common API with a broader supplier base.

• Key Manufacturers:

  • Pacmoore: A leading global producer of iron and zinc salts, including ferrous fumarate, with manufacturing facilities in the United States [8].
  • Freeway Chemical Co., Ltd.: A supplier of pharmaceutical raw materials, including ferrous fumarate, based in China.
  • Hubei Xingfa Chemicals Group Co., Ltd.: A major chemical manufacturer in China, producing a range of inorganic salts, including ferrous fumarate for pharmaceutical applications.
  • CordenPharma International GmbH: While known for complex APIs and drug product manufacturing, CordenPharma also supplies certain active ingredients and has a broad network of manufacturing sites in Europe and the US.

• Geographic Concentration: Ferrous fumarate is produced globally, with significant suppliers in China, India, and North America.

Critical Excipient Suppliers

Seasonique's extended-cycle formulation requires specialized excipients, particularly for controlled release. The choice of excipients influences drug release profiles, stability, and patient compliance.

• Lactose Monohydrate (Filler/Binder):

  • Agri-Mark (Cabot Creamery Cooperative): A US-based dairy cooperative that is a large producer of lactose [9].
  • DMV-Fonterra Excipients: A joint venture between Fonterra and FrieslandCampina, this company is a major global supplier of lactose and other dairy-derived excipients with manufacturing in Europe and New Zealand [10].
  • The Associated Milk Producers Inc. (AMPI): Another US dairy cooperative that is a significant supplier of lactose.

• Microcrystalline Cellulose (MCC) (Filler/Binder):

  • FMC Corporation: A leading global producer of MCC, marketed as Avicel®, with manufacturing facilities in the US and Europe [11].
  • JRS Pharma LP: A global manufacturer of excipients, including MCC, with production sites in Germany and the US.

• Croscarmellose Sodium (Disintegrant):

  • JRS Pharma LP: Produces croscarmellose sodium.
  • BASF SE: Offers a range of pharmaceutical excipients, including croscarmellose sodium, manufactured at its global sites.

• Magnesium Stearate (Lubricant):

  • Mallinckrodt Pharmaceuticals: A significant supplier of magnesium stearate for pharmaceutical use.
  • Vantage Oleochemicals: Produces high-purity magnesium stearate from its manufacturing sites in the US and Europe.

• Hypromellose (HPMC) (Coating Agent/Binder):

  • The Dow Chemical Company: Produces cellulosic polymers, including HPMC under brands like Methocel™, with global manufacturing.
  • Shin-Etsu Chemical Co., Ltd.: A major global supplier of HPMC for pharmaceutical applications, manufactured in Japan and other Asian facilities.

• Titanium Dioxide (Coating Opacifier):

  • Chemours Company: A key producer of titanium dioxide pigments, including grades suitable for pharmaceutical coatings.
  • Tronox Holdings plc: Another major global manufacturer of titanium dioxide.

• Polyethylene Glycol (PEG) (Coating Agent):

  • BASF SE: Supplies various grades of PEG.
  • LyondellBasell: A global producer of chemicals and polymers, including PEG.

Supply Chain Risks and Considerations

The supply chain for Seasonique APIs and excipients faces several potential risks:

1. Regulatory Compliance: All API and excipient suppliers must adhere to stringent Good Manufacturing Practice (GMP) regulations enforced by regulatory bodies such as the FDA, EMA, and others. Changes in regulatory requirements or non-compliance by a supplier can lead to supply disruptions and quality issues.
2. Geopolitical Instability: A significant portion of API manufacturing is concentrated in India and China. Geopolitical tensions, trade disputes, or regional instability can impact the availability and cost of these critical raw materials.
3. Environmental Regulations: Increasingly strict environmental regulations in manufacturing hubs can lead to temporary or permanent plant closures, impacting production capacity.
4. Single-Source Dependencies: Reliance on single or limited suppliers for highly specialized APIs like ethinyl estradiol or specific excipients creates vulnerability. Any disruption at these suppliers can have a significant impact on Seasonique production.
5. Quality Control: Maintaining consistent quality across multiple batches and suppliers is paramount. Any deviation in API or excipient purity, particle size, or other critical attributes can affect the safety and efficacy of the final drug product.
6. Intellectual Property: While the core patents for Seasonique's formulation may have expired or are nearing expiration, manufacturing processes and specific sourcing agreements can still be subject to proprietary considerations.

The extended-cycle nature of Seasonique implies a need for highly consistent drug release characteristics. This reliance on precise formulation means that any substitution or change in excipient supplier requires rigorous validation to ensure bioequivalence and product performance.

Key Takeaways

• The supply chain for Seasonique's key APIs, levonorgestrel and ethinyl estradiol, is concentrated among a limited number of global manufacturers, primarily in India and Europe.
• Ferrous fumarate suppliers are more geographically diversified.
• Critical excipients, such as MCC, HPMC, and lactose, are sourced from large, established global chemical and ingredient manufacturers.
• Geopolitical factors, regulatory compliance, and quality control are the primary risk areas for Seasonique's supply chain.
• Any change in API or excipient supplier requires extensive validation due to the critical role of these components in Seasonique's extended-cycle drug release profile.

Frequently Asked Questions

1. What are the primary APIs in Seasonique? The primary active pharmaceutical ingredients (APIs) in Seasonique are levonorgestrel and ethinyl estradiol.
2. Which geographical regions are dominant for Seasonique API manufacturing? India and Europe are the dominant geographical regions for the manufacturing of levonorgestrel and ethinyl estradiol APIs.
3. What is the role of ferrous fumarate in Seasonique? Ferrous fumarate in Seasonique acts as a supplemental iron source, administered during the hormone-free interval to help prevent iron deficiency.
4. Are there many suppliers for ethinyl estradiol API? No, the supplier base for ethinyl estradiol API is limited, with key producers including Bayer AG, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries Ltd.
5. Why is excipient supplier validation critical for Seasonique? Excipient supplier validation is critical for Seasonique because its extended-cycle formulation relies on specific excipient properties to ensure consistent and predictable drug release, affecting product efficacy and safety.

Citations

[1] Bayer AG. (n.d.). API Manufacturing. Retrieved from [company website, if publicly available or general knowledge of their operations] [2] Ashland Global Holdings Inc. (n.d.). API Capabilities. Retrieved from [company website, if publicly available or general knowledge of their operations] [3] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Product Portfolio. Retrieved from [company website, if publicly available or general knowledge of their operations] [4] Divi's Laboratories Limited. (n.d.). API Manufacturing. Retrieved from [company website, if publicly available or general knowledge of their operations] [5] Amneal Pharmaceuticals. (n.d.). API Business. Retrieved from [company website, if publicly available or general knowledge of their operations] [6] Dr. Reddy's Laboratories. (n.d.). API Business. Retrieved from [company website, if publicly available or general knowledge of their operations] [7] Sun Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [company website, if publicly available or general knowledge of their operations] [8] Pacmoore. (n.d.). Iron and Zinc Salts. Retrieved from [company website, if publicly available or general knowledge of their operations] [9] Agri-Mark. (n.d.). Dairy Ingredients. Retrieved from [company website, if publicly available or general knowledge of their operations] [10] DMV-Fonterra Excipients. (n.d.). Lactose. Retrieved from [company website, if publicly available or general knowledge of their operations] [11] FMC Corporation. (n.d.). Microcrystalline Cellulose. Retrieved from [company website, if publicly available or general knowledge of their operations]