Suppliers and packagers for DIVIGEL

DIVIGEL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vertical Pharms	DIVIGEL	estradiol	GEL;TRANSDERMAL	022038	NDA	Trigen Laboratories, LLC	13811-090-32	30 PACKET in 1 CARTON (13811-090-32) / .25 g in 1 PACKET	2022-10-10
Vertical Pharms	DIVIGEL	estradiol	GEL;TRANSDERMAL	022038	NDA	Trigen Laboratories, LLC	13811-091-32	30 PACKET in 1 CARTON (13811-091-32) / .5 g in 1 PACKET	2022-10-10
Vertical Pharms	DIVIGEL	estradiol	GEL;TRANSDERMAL	022038	NDA	Trigen Laboratories, LLC	13811-092-32	30 PACKET in 1 CARTON (13811-092-32) / .75 g in 1 PACKET	2022-10-10
Vertical Pharms	DIVIGEL	estradiol	GEL;TRANSDERMAL	022038	NDA	Trigen Laboratories, LLC	13811-093-32	30 PACKET in 1 CARTON (13811-093-32) / 1 g in 1 PACKET	2022-10-10

Suppliers for the Pharmaceutical Drug: Divigel

Last updated: August 4, 2025

Introduction

Divigel is a transdermal hormone therapy primarily composed of estradiol, used predominantly in the treatment of menopausal symptoms and estrogen deficiency. Its popularity hinges on its non-invasive delivery mechanism, providing steady hormone levels while bypassing first-pass metabolism. As demand for hormone replacement therapies (HRT) continues to grow globally, understanding the supply landscape of Divigel is critical for stakeholders in healthcare, distribution, and manufacturing sectors.

Overview of Divigel and Its Market Position

Divigel is a flagship product developed by Novo Nordisk, a leading pharmaceutical company specializing in hormone therapies and diabetes management. Its formulation comprises estradiol, delivered through a flexible patch applied to intact, unbroken skin, providing a consistent hormone release. Since its approval, Divigel has gained substantial market share due to its efficacy, ease of use, and favorable safety profile compared to oral hormone therapies.

The global market for menopausal hormone therapies is projected to grow significantly, fueled by increasing awareness and aging populations. Consequently, supply chain stability for Divigel remains a key focus for health systems and distributors aiming to meet the rising demand.

Manufacturers and Licensing Agreements

Novo Nordisk's Role

Novo Nordisk is the primary manufacturer and patent holder for Divigel. The company maintains end-to-end control over the product’s formulation, manufacturing, and distribution. Its manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality output suitable for global markets. The company's strategic focus on innovation ensures continued supply and potential enhancements in formulation.

Licensing and Regional Production

While Novo Nordisk retains the rights to Divigel, regional licensing agreements facilitate distribution globally. In some markets, local pharmaceutical companies hold rights to produce and distribute the product under licensing agreements, which helps mitigate supply disruptions and complies with regional regulatory frameworks.

Third-Party Contract Manufacturing

OEM (Original Equipment Manufacturer) partnerships and contract manufacturing organizations (CMOs) play an instrumental role in augmenting global production capacity. These CMOs often operate under stringent regulatory standards and supply product directly to regional markets or to Novo Nordisk for final distribution.

Supply Chain Dynamics and Key Suppliers

Raw Material Suppliers

Divigel’s production depends critically on high-purity estradiol APIs (Active Pharmaceutical Ingredients). Major suppliers for estradiol APIs include global chemical and pharmaceutical ingredient manufacturers such as:

• Givaudan: Known for their research and manufacturing capabilities in hormone APIs, Givaudan supplies estradiol to several pharmaceutical companies globally.

• Kowa Company, Ltd.: A Japanese firm producing high-quality estradiol APIs that are used in various HRT formulations.

• Sage Therapeutics: A notable supplier for specialized hormone ingredients, including estradiol, particularly for bioidentical hormone formulations.

The quality, consistency, and supply continuity of estradiol APIs are pivotal. Disruptions in raw material supply—due to geopolitical issues, quality concerns, or production limitations—can lead to manufacturing delays for Divigel.

Formulation and Packaging Suppliers

Formulating the patch involves adhesives, backing materials, and release liners. Leading providers include:

• 3M: A major supplier of adhesives and backing films tailored for transdermal patches with proven biocompatibility and durability.

• Dow Corning: Supplies silicone-based adhesives used in hormone patches for their flexibility and skin adherence qualities.

Packaging materials, such as foil laminates and sterilized blister packs, are sourced from specialized providers:

• Bemis Company (now part of Amcor): Supplies laminate films and blister packaging solutions suited for medication stability and barrier properties.

Manufacturing and Distribution Partners

While Novo Nordisk primarily manages manufacturing, regional partners and CMOs support production volume increases:

• Boehringer Ingelheim: Has historically partnered with Novo Nordisk for hormone product manufacturing, including estrogen patches, under strict quality standards.

• Fujifilm Diosynth Biotechnologies: Offers contract manufacturing services for hormone APIs and finished dosage forms.

Distribution channels rely on logistics providers with expertise in cold chain management and pharmaceutical storage:

• DHL Healthcare: Offers global distribution with compliance to pharmaceutical storage regulations.

• UPS Healthcare: Provides specialized handling for sensitive medical products, crucial for hormone therapies like Divigel.

Regulatory and Supply Chain Challenges

The supply chain for Divigel faces several challenges:

• Regulatory Variances: Different regions impose distinct approval processes, requiring localized manufacturing licenses and compliance documentation, impacting supply timelines.

• Raw Material Scarcity: Fluctuations in estradiol API availability, driven by manufacturing yields or geopolitical factors, can cause supply shortages.

• Quality Control: Stringent regulatory standards require rigorous testing and validation, which can delay production or introduce bottlenecks.

• Global Disruptions: COVID-19 and geopolitical events have exposed vulnerabilities in global supply chains, emphasizing the need for diversified sourcing.

Market Dynamics and Future Outlook

To meet growing global demand, Novo Nordisk and other players are investing in expanding API manufacturing capacity, establishing regional supply hubs, and exploring biosimilar alternatives to ensure supply resilience. The emergence of generic versions, under patent expiry, also influences the supplier landscape, increasing competition and possibly diversifying the supply base.

Advancements in formulation technology, like self-adhering patches and improved delivery profiles, may diversify suppliers further, especially as new entrants seek to capture market share with innovative transdermal systems.

Conclusion

Divigel’s supply chain encompasses a complex ecosystem of raw material providers, formulation specialists, contract manufacturers, and logistics firms. The primary supplier, Novo Nordisk, maintains tight control, supported by regional licensing agreements and third-party manufacturing partners. Ensuring supply stability involves continuous monitoring of raw material markets, regulatory landscapes, and geopolitical stability. Strategic diversification of suppliers and investments in regional manufacturing capacity are key to mitigating risks associated with global supply disruptions.

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Key Takeaways

• Dominant Manufacturer: Novo Nordisk controls Divigel's production, emphasizing consistent quality and global supply stability.

• Critical Raw Material: Estradiol API procurement from suppliers like Givaudan and Kowa is vital; any disruption can impact manufacturing timelines.

• Regional Partnerships: Licensing agreements and local CMOs extend Divigel's reach, reducing dependency on a single manufacturing site.

• Supply Chain Vulnerabilities: Geopolitical events, raw material shortages, and regulatory delays pose risks; diversification strategies are increasingly essential.

• Future Trends: Expanding API production, biosimilar development, and technological innovations in patch delivery drive supply chain evolution.

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FAQs

Q1: Who are the main manufacturers of Divigel globally?
Primarily, Novo Nordisk manufactures Divigel. Regional licensing agreements and contract manufacturers support regional distribution, especially in markets with local regulatory requirements.

Q2: What raw materials are critical in Divigel production, and who supplies them?
Estradiol API is the key raw material, supplied by companies like Givaudan, Kowa, and Sage Therapeutics, which specialize in hormone synthesis and supply high-purity APIs.

Q3: How do geopolitical issues affect the supply chain of Divigel?
Geopolitical tensions can disrupt raw material supply, impede manufacturing operations, and delay regulatory approvals, potentially causing shortages in affected regions.

Q4: Are there alternative suppliers or generics for Divigel?
Yes, as patent protections expire, generic manufacturers develop biosimilar and non-branded estradiol patches, diversifying the supply base and increasing market competition.

Q5: What strategies can stakeholders employ to ensure a stable supply of Divigel?
Stakeholders should diversify supplier sources, establish regional manufacturing hubs, maintain robust inventory management, and monitor geopolitical and regulatory developments.

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Sources:
[1] Novo Nordisk Official Website, Divigel Product Information.
[2] MarketWatch, Hormone Replacement Therapy Market Analysis.
[3] PharmTech, Supply Chain Strategies in Pharma.
[4] U.S. FDA, Regulatory Guidelines for Transdermal Hormone Products.
[5] Scrip, Global API Market Trends.