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

Suppliers for the Pharmaceutical Drug: Seasonique

Last updated: July 30, 2025

Introduction

Seasonique, a combination oral contraceptive marketed primarily for extended-cycle or continuous use, offers women a contraceptive option with fewer periods per year. The drug combines ethinylestradiol and levonorgestrel, providing effective hormonal birth control. As with many pharmaceuticals, the availability, quality, and sourcing of ingredients are critical for manufacturer compliance, safety, and market supply. This analysis explores the key suppliers involved in producing Seasonique, including active pharmaceutical ingredient (API) suppliers, finished drug manufacturers, and distribution channels.

Overview of Seasonique’s Composition and Manufacturing Process

Seasonique’s formulation relies on two active components: ethinylestradiol and levonorgestrel. These compounds are synthesized, purified, and formulated into pills by licensed pharmaceutical manufacturers. The manufacturing process involves sourcing raw materials, synthesizing APIs under Good Manufacturing Practices (GMP), and filling finished dosage forms.

Ethinylestradiol is a synthetic estrogen, primarily produced by large-scale chemical manufacturers.
Levonorgestrel is a synthetic progestin, synthesized through complex chemical pathways requiring specialized chemistry providers.

The final product undergoes rigorous testing for purity, stability, and bioavailability before distribution to clinics and pharmacies.

Key API Suppliers for Seasonique

1. Ethinylestradiol Suppliers

Major suppliers of ethinylestradiol are established pharmaceutical ingredient manufacturers with global presence:

• Glyndon Laboratories, Inc. – Known for producing high-purity ethinylestradiol used in oral contraceptives.
• Hetero Labs Ltd. – An Indian API manufacturer with a significant share in hormonal APIs, supplying to global markets.
• Dr. Reddy's Laboratories – Produces ethinylestradiol for both generic and branded drugs, with extensive manufacturing capacities.
• Mitsubishi Tanabe Pharma Corporation – Japanese company providing high-quality hormonal APIs.

These suppliers follow stringent GMP standards, complying with regulations such as the FDA and EMA.

2. Levonorgestrel Suppliers

Levonorgestrel production is concentrated among specialized chemical companies:

• Bayer HealthCare – Original patent holder and a major supplier of levonorgestrel-based contraceptives, including raw materials.
• Hetero Labs Ltd. – Supplies levonorgestrel APIs for generic formulations.
• Sandoz (Novartis) – Provides a variety of hormonal APIs, including levonorgestrel.
• Sun Pharmaceutical Industries Ltd. – Indian manufacturer involved in hormone API production and supply.

The API's synthesis involves multiple chemical steps requiring high-level process control and purity standards.

Finished Drug Manufacturing and Packaging

While API suppliers provide the foundational ingredients, the actual finished product—Seasonique tablets—is manufactured by specialized pharmaceutical companies with licensed manufacturing facilities that adhere to health regulatory standards.

• Allergan (now part of AbbVie) – As the original manufacturer of Seasonique, Allergan oversaw the formulation, production, and distribution.
• Contract Manufacturing Organizations (CMOs) – Many pharmaceutical companies utilize CMOs for large-scale fill-finish, packaging, and distribution operations, often sourcing APIs from the aforementioned suppliers.

The manufacturing plants are located in regions with strict GMP compliance, such as the United States, Europe, and India.

Distribution and Supply Chain

The distribution network for Seasonique encompasses global pharmaceutical distributors, wholesalers, and pharmacy chains. These entities source the finished product from manufacturing plants and ensure compliance with regional import/export regulations.

Specialized pharmaceutical distributors such as:

• McKesson Corporation
• AmerisourceBergen Corporation
• Cardinal Health

partner with manufacturers to facilitate the broad market availability of Seasonique.

Regulatory Considerations

Suppliers of Seasonique must meet regulatory approvals from agencies like the FDA, EMA, and other relevant bodies. API suppliers are critical in maintaining the quality and safety-profile of the drug, given that impurities or variability in APIs can compromise efficacy or safety.

Manufacturing facilities undergo regular audits and inspections to ensure conformity with GMP standards. These regulations influence sourcing decisions, quality assurance, and supply chain robustness.

Current Dynamics in the Supplier Market

The marketplace for hormonal APIs, including ethinylestradiol and levonorgestrel, has experienced ongoing shifts driven by:

• Patent expirations and emergence of generics – Increasing competition among API manufacturers in India and China, reducing costs.
• Supply chain disruptions – Due to geopolitical factors, global crises like pandemics, and manufacturing capacity constraints.
• Regulatory tightening – Demanding higher API purity and adherence to environmentally sustainable manufacturing practices.

These factors influence pharmaceutical companies' sourcing strategies, emphasizing supply stability and Quality by Design (QbD).

Conclusion

Securing reliable suppliers for Seasonique involves comprehensive vetting of API producers, finished drug manufacturers, and distribution channels. Leading API suppliers such as Hetero Labs, Dr. Reddy’s, Bayer, and Sun Pharma play central roles. The manufacturing process's regulatory environment underscores the importance of quality, safety, and compliance. Pharmaceutical companies' strategic sourcing must account for the current dynamics in the API market, regulatory landscape, and geopolitical considerations to maintain consistent supply of this contraceptive product.

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Key Takeaways

• API Quality is Paramount: Suppliers like Hetero, Dr. Reddy’s, Bayer, and Sun Pharma are critical due to their proven quality and regulatory compliance.
• Market Dynamics Impact Supply Chain: Patent expirations and increasing generic production have expanded API sourcing options, but geopolitical risks necessitate diversified supplier relationships.
• Regulatory Compliance is Critical: Suppliers must adhere to GMP standards and regulatory approvals, which safeguard the efficacy and safety of Seasonique.
• Regional Manufacturing Hubs: India and China dominate the hormonal API manufacturing landscape, extending cost benefits but requiring rigorous oversight.
• Supply Chain Resilience is Vital: Manufacturers should develop contingency plans to mitigate risks related to API shortages or logistical disruptions.

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FAQs

1. Who are the primary API suppliers for ethinylestradiol used in Seasonique?
Leading producers include Hetero Labs, Dr. Reddy’s Laboratories, Mitsubishi Tanabe Pharma, and Glyndon Laboratories, all following strict GMP standards (sources: [1], [2]).

2. What are the main challenges in sourcing levonorgestrel APIs?
Challenges include meeting high purity standards, regulatory compliance, and geopolitical risks impacting manufacturing stability, chiefly in regions like India and China (sources: [3]).

3. How does regulatory oversight influence API quality in Seasonique production?
Regulatory bodies such as the FDA mandate rigorous GMP compliance, regular inspections, and testing, ensuring API purity and safety standards that directly affect drug efficacy (sources: [4]).

4. Are there alternative suppliers for Seasonique’s ingredients?
Yes, aside from traditional suppliers, emerging manufacturers in Southeast Asia and South America are entering the market, offering competitive options with regulatory approvals (sources: [5]).

5. How does geopolitical instability affect the supply chain for Seasonique?
It can disrupt API manufacturing, cause delays, or increase costs. Companies are increasingly diversifying suppliers and regions to mitigate such risks (sources: [6]).

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Sources

1. [Insert source related to Glyndon Laboratories or major API suppliers]
2. [Insert source regarding Hetero Labs and Dr. Reddy’s API manufacturing]
3. [Insert source about levonorgestrel synthesis and suppliers]
4. [Insert source on GMP standards and regulatory oversight]
5. [Insert analysis on emerging API markets]
6. [Insert report on geopolitical and supply chain risks]