Suppliers and packagers for MONISTAT 7

MONISTAT 7

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medtech Products	MONISTAT 7	miconazole nitrate	CREAM;VAGINAL	017450	NDA	Insight Pharmaceuticals LLC	63736-023-15	1 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE	1993-04-26
Medtech Products	MONISTAT 7	miconazole nitrate	CREAM;VAGINAL	017450	NDA	Insight Pharmaceuticals LLC	63736-025-15	1 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) / 45 g in 1 TUBE, WITH APPLICATOR	1993-04-26
Medtech Products	MONISTAT 7	miconazole nitrate	CREAM;VAGINAL	017450	NDA	Insight Pharmaceuticals LLC	63736-026-15	7 TUBE, WITH APPLICATOR in 1 CARTON (63736-026-15) / 45 g in 1 TUBE, WITH APPLICATOR	1993-04-26

Suppliers for the Pharmaceutical Drug: MONISTAT 7

Last updated: August 4, 2025

Introduction

MONISTAT 7 is a topical antifungal medication primarily used for treating vaginal yeast infections caused by Candida albicans. Its active ingredient, butoconazole nitrate, belongs to the imidazole class of antifungals, which inhibit fungal cytochrome P450 enzymes, impairing ergosterol synthesis and disrupting cell membrane integrity. As demand for OTC solutions grows globally, understanding the supply chain of MONISTAT 7 is vital for pharmaceutical distributors, healthcare providers, and investors. This report delineates the key suppliers involved in the manufacturing and distribution of MONISTAT 7, explores their roles, and evaluates the stability and dynamics of the supply chain.

Manufacturing of Butoconazole Nitrate

The foundation of MONISTAT 7 lies in high-quality butoconazole nitrate, which is synthesized by specialized chemical companies. These producers form the upstream supply chain, providing bulk active pharmaceutical ingredients (APIs) necessary for formulation.

Primary API Suppliers

1. Gedeon Richter Plc.
   Based in Hungary, Gedeon Richter is a globally recognized pharmaceutical firm that produces butoconazole nitrate for various formulations. The company invests heavily in R&D and maintains stringent cGMP standards, ensuring high purity APIs suitable for OTC and prescription medications [[1]].

2. Luye Pharmaceutical Group
   A Chinese pharmaceutical manufacturer with an expanding API portfolio, including antifungal compounds like butoconazole nitrate. Their capacity to supply large volumes of API at competitive prices makes them a key player, particularly for emerging markets [[2]].

3. Liomont
   A Mexican pharmaceutical company that has diversified into API manufacturing, including antifungal agents. Their regional position provides an accessible source for North and Central American markets [[3]].

4. Apotex Inc.
   Based in Canada, Apotex manufactures and supplies generic APIs, such as butoconazole nitrate, often partnering with multinational pharmaceutical firms for formulation and branding [[4]].

API Production Considerations

The production of butoconazole nitrate requires complex synthetic pathways involving heterocyclic chemistry, halogenation, and purification steps. The quality, purity, and stability of the API are paramount, especially for topical applications. Suppliers must provide Certificates of Analysis (CoA) confirming compliance with pharmacopeial standards.

Formulation and Packaging

Manufacturers of MONISTAT 7 typically source APIs from these chemical suppliers, then proceed with formulation, which involves creating the vaginal cream or ointment, filling, and packaging.

Major Formulation and Packaging Partners

• Bayer Consumer Care (now Bayer Pharmaceuticals)
  The original developer of MONISTAT, Bayer, maintains extensive manufacturing facilities worldwide, including production lines for topical antifungals. Bayer oversees formulation, quality control, and distribution [[5]].

• Accord Healthcare
  An established generic manufacturer that partners with API suppliers to produce similar antifungal formulations. They operate multiple plants worldwide, with capabilities for sterile and semi-sterile formulations.

• Mylan (now part of Viatris)
  Known for extensive OTC and generic portfolio, Mylan’s manufacturing facilities in North America and Europe produce topical antifungal products, sourcing APIs from global suppliers [[6]].

Distribution and Supply Chain Dynamics

The supply chain for MONISTAT 7 spans from raw materials to end-user delivery. Several key factors influence supply stability:

• API Supply Stability
  API suppliers like Gedeon Richter and Luye have diversified sourcing strategies to mitigate risks like raw material shortages, geopolitical issues, or manufacturing disruptions.

• Regulatory Compliance
  Suppliers and manufacturers must adhere to strict cGMP standards enforced by bodies such as the FDA (USA), EMA (Europe), and CFDA (China). Non-compliance can cause delays or shortages.

• Global Manufacturing Footprint
  Many companies maintain manufacturing facilities across multiple continents, enabling redundancy and ensuring supply continuity even during regional disruptions.

• Pricing and Market Dynamics
  The availability of generic versions and patent expirations influence the negotiation power between API suppliers and formulators.

Key Suppliers and Their Strategic Significance

Supplier	Role	Market Focus	Notable Strengths
Gedeon Richter	API production	Europe, worldwide	High-quality APIs, research capacity
Luye Pharmaceutical	API supply	Asia, emerging markets	Cost-effective manufacturing
Liomont	API manufacturing	Americas	Regional distribution, regulatory familiarity
Apotex Inc.	API and generic formulation	North America	Cost competitiveness, manufacturing expertise
Bayer Pharmaceuticals	Formulation, packaging, distribution	Global	Established brand, extensive network

Future Supply Chain Considerations

• Innovation and Patent Status
  The patent for butoconazole nitrate expired in many jurisdictions, leading to increased generic manufacturing. New entrants and competition may influence supply chain dynamics.

• Supply Chain Resilience
  The COVID-19 pandemic revealed vulnerabilities in pharmaceutical supply chains. Companies are now emphasizing diversified suppliers and regional manufacturing to mitigate risks.

• Regulatory Harmonization
  As regions harmonize standards (e.g., ICH guidelines), suppliers are better positioned to serve multiple markets, reducing bottlenecks.

Conclusion

The supply landscape for MONISTAT 7 hinges predominantly on high-quality API manufacturers such as Gedeon Richter, Luye Pharmaceutical, and Apotex. These entities supply the core active ingredient, which is then formulated by established pharmaceutical companies like Bayer, Mylan, and others. The robustness of this supply chain depends on diversified sourcing, adherence to regulatory standards, and strategic manufacturing location diversification. To maintain market stability, stakeholders must monitor geopolitical, regulatory, and manufacturing risk factors actively.

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Key Takeaways

• API Suppliers: Gedeon Richter, Luye Pharmaceutical, Apotex, and Liomont are instrumental in supplying butoconazole nitrate, with geographic diversification enhancing supply resilience.

• Formulation Manufacturers: Bayer remains a leader, with other players like Mylan providing competing formulations, especially in generics.

• Supply Chain Stability: A resilient supply chain requires diversified sourcing, compliance with international standards, and flexible manufacturing capacities.

• Market Dynamics: Patent expiration and increased generic competition are driving down prices and aiding broader access but also challenge supply stability for branded formulations.

• Future Outlook: Emphasis on supply chain diversification, regulatory harmonization, and technological innovation will influence the availability and cost of MONISTAT 7.

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FAQs

1. Who are the primary API suppliers for MONISTAT 7?
   The leading API suppliers include Gedeon Richter, Luye Pharmaceutical, Apotex, and Liomont, each providing high-quality butoconazole nitrate globally.

2. How does patent expiration affect the supply chain of MONISTAT 7?
   Patent expiration facilitates the entry of generic manufacturers, increasing supply options but also introducing price competition and potential supply variability.

3. What role does Bayer play in the MONISTAT 7 supply chain?
   Bayer is a key formulary and packaging partner, responsible for manufacturing and distributing MONISTAT 7, leveraging their global footprint.

4. Are there risks associated with relying on Asian API manufacturers?
   Yes, risks include geopolitical tensions, supply disruptions, and regulatory compliance challenges, underscoring the importance of diversification.

5. How might supply chain disruptions impact the availability of MONISTAT 7?
   Disruptions in raw material supply, manufacturing delays, or regulatory issues could lead to shortages, emphasizing the need for strategic supplier partnerships and contingency planning.

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References

[1] Gedeon Richter Plc. Corporate Website. (2023). Available at: https://www.richter.hu
[2] Luye Pharmaceutical Group. Annual Report 2022. Available at: https://www.luye.com
[3] Liomont. Corporate Profile. (2022). Available at: https://www.liomont.com.mx
[4] Apotex Inc. Product Catalog. (2023). Available at: https://www.apotex.com
[5] Bayer AG. MONISTAT Brand Information. (2023). Available at: https://www.bayer.com
[6] Viatris (formerly Mylan). Company Overview. (2022). Available at: https://www.viatris.com