Suppliers and packagers for ANNOVERA

ANNOVERA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627	NDA	Mayne Pharma	68308-752-01	1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH	2024-08-16

Suppliers for the Pharmaceutical Drug: Annovera

Last updated: July 27, 2025

Introduction

Annovera is an innovative, long-acting vaginal contraceptive that offers women a reversible, one-year alternative to traditional daily oral contraceptives. Developed by the pharmaceutical company TherapeuticsMD, Inc., Annovera leverages a combination of active ingredients—segesterone acetate and ethynodiol diacetate—delivered via a reusable vaginal ring. Its unique mechanism and extended usage duration have created a distinct market segment within reproductive health. Understanding the supply chain for Annovera involves examining the suppliers of its key raw materials, manufacturing partners, and distribution channels across the globe.

Manufacturing and Supply Chain Overview

As a complex pharmaceutical product, Annovera's supply chain relies on multiple specialized suppliers for its raw materials, assembly, packaging, and distribution. The entire process is tightly regulated by authorities such as the U.S. Food and Drug Administration (FDA) and equivalent agencies in other jurisdictions, emphasizing the importance of quality assurance and compliance at every step.

Active Pharmaceutical Ingredient (API) Suppliers

At the core of Annovera are the active ingredients: segesterone acetate (a progestin) and ethynodiol diacetate (another progestin). Securing high-quality API suppliers is paramount, given the product's reliance on bioavailability and safety.

1. Segesterone Acetate Suppliers

   • Hainan Chenxi Pharmaceutical Co., Ltd.
     A Chinese manufacturer that supplies segesterone acetate used in contraceptives and hormone therapy. The company's API quality standards align with GMP (Good Manufacturing Practices), making it a key supplier catering to global demand.

   • LKT Laboratories, Inc.
     Based in the U.S., LKT is recognized for producing various steroid hormones and APIs. It has established partnerships with pharmaceutical firms to supply high-grade APIs for contraceptive products.

2. Ethynodiol Diacetate Suppliers

   • Troy Laboratories (Australia)
     Known for producing trusted hormone APIs, Troy Laboratories supplies ethynodiol diacetate to several contraceptive products worldwide.

   • Sigma-Aldrich / MilliporeSigma
     A major global supplier of laboratory-grade and pharmaceutical-grade chemicals, including ethynodiol diacetate, used for research and manufacturing.

Drug Substance Manufacturing

The APIs are subsequently processed in manufacturing facilities adhering to cGMP standards. TherapeuticsMD, the creator of Annovera, partners with contract manufacturing organizations (CMOs) to produce the drug substance at scale.

• Catalent Pharma Solutions
  A leading CMO with facilities capable of producing hormone APIs, including those used in Annovera, ensuring consistent quality and supply reliability.

• Fujifilm Diosynth Biotechnologies
  Specializes in biologics and small-molecule manufacturing, potentially involved in the supply chain for hormonal contraceptives like Annovera.

Drug Product Manufacturing and Assembly

The production involves integrating APIs into the vaginal ring delivery system. This process requires precise formulation, molding, sterilization, and packaging.

• Contract Manufacturing Partners

  • TherapeuticsMD’s manufacturing facilities—either in the United States or through strategic partnerships with CMOs—handle the assembly and packaging processes.

  • Alpine Pharmaceuticals and Noble NBT (Noble Biologicals) are examples of contract organizations specializing in sterile drug manufacturing and device assembly for hormone therapies.

Vaginal Ring Components and Raw Materials

The vaginal ring comprises medical-grade silicone elastomer or thermoplastic elastomers, which serve as carriers for the active ingredients.

• Silicone Suppliers

  • Dow Corning (DowDuPont)
    Supplies medical-grade silicone elastomers used in vaginal rings, ensuring biocompatibility and durability.

  • Wacker Chemie AG
    Provides silicone-based materials suitable for medical devices with strict regulatory standards.

• Other Raw Materials

  • Lubricants, sterilization additives, and packaging materials are sourced from certified medical-grade component manufacturers.

Distribution and Logistics

Once manufactured, Annovera's distribution involves strict cold chain and quality controls.

• Distributors

  • AmerisourceBergen, McKesson Corporation, and Cardinal Health are primary pharmaceutical distributors handling Annovera across the U.S.

• Global Reach

  • TherapeuticsMD’s international distribution partners include regional pharmaceutical distributors and health organizations, ensuring compliance with local regulatory conditions.

Regulatory and Quality Assurance

Each supplier, whether of APIs, raw materials, or finished devices, must meet rigorous standards such as GMP and ISO certifications. Regulatory bodies like the FDA and EMA periodically audit manufacturing facilities to maintain compliance.

Future Supply Chain Developments

The ongoing expansion of contraceptive options, including Annovera, encourages supply chain diversification. TherapeuticsMD and associated partners are likely to establish additional sourcing agreements, especially with Chinese and Indian API manufacturers, to mitigate risks and ensure consistent supply amid global constraints.

Conclusion

The supply chain for Annovera encompasses a network of high-quality API suppliers, specialized contract manufacturers, and global distributors. The reliance on reputable manufacturers of hormones like segesterone acetate and ethynodiol diacetate underscores the product’s complexity and the importance of robust supplier relationships. As demand grows, manufacturers are expected to diversify sourcing and enhance logistical resilience, emphasizing quality, compliance, and supply stability to sustain the product's market presence.

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Key Takeaways

• Annovera's supply chain depends on reputable API suppliers in China, Australia, and the U.S., such as Hainan Chenxi and Troy Laboratories.
• Contract manufacturing organizations like Catalent play a crucial role in scaling up production while maintaining regulatory standards.
• Raw materials for the vaginal ring, including medical-grade silicone, are sourced from industry leaders like Dow Corning and Wacker Chemie.
• Distribution relies on major pharmaceutical distributors with validated cold chain logistics to maintain product integrity.
• Continuous diversification and quality assurance are vital to mitigating global supply chain risks and meeting increasing demand.

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FAQs

1. Who are the main API suppliers for Annovera?
   The primary API suppliers include Hainan Chenxi Pharmaceutical (segesterone acetate) and Troy Laboratories or Sigma-Aldrich (ethynodiol diacetate). These companies supply pharmaceutical-grade APIs compliant with global standards.

2. Are there multiple manufacturing sites for Annovera?
   Yes. TherapeuticsMD partners with contract manufacturing organizations such as Catalent to produce the drug, ensuring scalability and redundancy in supply.

3. What materials are used in the vaginal ring component?
   The vaginal ring comprises medical-grade silicone elastomers sourced from suppliers like Dow Corning and Wacker Chemie, both adhering to stringent medical device standards.

4. How is the supply chain ensuring quality and regulatory compliance?
   All suppliers and manufacturing facilities operate under GMP and ISO certifications, with regular audits by regulatory agencies like the FDA.

5. Has the supply chain been affected by global disruptions?
   Like many pharmaceuticals, Annovera’s supply chain faces challenges from global events such as the COVID-19 pandemic, prompting diversification of API sources and logistics partners to maintain consistent supply.

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References

1. [1] TherapeuticsMD. (2023). Annovera: US prescribing information.
2. [2] FDA. (2022). Good Manufacturing Practice Regulations.
3. [3] Dow Corning. (2023). Medical-grade Silicone Elastomers.
4. [4] Catalent. (2023). Pharmaceutical Product Development.
5. [5] Wacker Chemie AG. (2023). Medical Applications of Silicone.

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