Suppliers and packagers for GYNAZOLE-1

GYNAZOLE-1

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-01	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-02	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Gynazole-1

Introduction
Gynazole-1 is a widely prescribed topical antifungal medication primarily used to treat vulvovaginal candidiasis, commonly known as yeast infections. Its active ingredient, butoconazole nitrate, belongs to the imidazole class of antifungals. As a marketed pharmaceutical product, Gynazole-1 is produced and supplied by various manufacturers globally, with key suppliers playing pivotal roles in distribution channels across different regions. Understanding the landscape of Gynazole-1 suppliers is critical for healthcare providers, pharmacies, and procurement organizations aiming to ensure consistent access to quality-assured medications.

Manufacturers and Supply Chain Overview
Gynazole-1’s production involves several stages, including synthesis of butoconazole nitrate, formulation, packaging, and distribution. The drug’s global supply hinges on a combination of patent-held manufacturing rights, licensed generic producers, and authorized distributors.

Primary Manufacturer: Core Pharmaceutical and Licensing Agreements
The original patent holder for Gynazole-1 was Watson Pharmaceuticals (now Allergan, after acquisition and restructuring) [1]. This company, at the time, was the primary manufacturer and supplier of the brand-name product. After patent expiry or license agreements, numerous generic manufacturers entered the market, increasing supply diversity and competitive pricing.

Generic Manufacturers and Key Suppliers
Once the patent expired, several pharmaceutical companies obtained manufacturing licenses or entered agreements to produce butoconazole nitrate formulations, including Gynazole-1. Notable suppliers include:

• Lupin Limited (India): As a prominent generics manufacturer, Lupin produces topical antifungals including butoconazole nitrate, supplying to various markets worldwide [2].
• Hetero Drugs (India): Known for producing a wide array of dermatological and gynecological products, Hetero offers generic versions comparable to Gynazole-1 and supplies global markets [3].
• Sandoz (Novartis): As a leading biosimilar and generic drug manufacturer, Sandoz distributes similar antifungal formulations, including butoconazole nitrate, in licensed markets [4].
• Mundipharma: Though primarily involved in pain management, Mundipharma holds licensing rights for some antifungal medications in specific regions, including Gynazole-1 variants [5].

Regional Suppliers and Distribution Networks
In North America, Gynazole-1 is often supplied directly by Allergan or licensed generic counterparts. The distribution is managed through established pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen, ensuring broad accessibility across healthcare settings.

In European markets, suppliers tend to include local generic manufacturers licensed by the original patent holders or through regional licensing agreements, with distribution managed via regional pharmaceutical networks.

In emerging markets and developing economies, local manufacturers often produce biosimilar or generic versions under licensing agreements, sometimes with regulatory approvals from local agencies such as the Central Drugs Standard Control Organization (CDSCO) in India or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Regulatory Considerations and Quality Assurance
Suppliers must comply with stringent regulatory standards, including Good Manufacturing Practices (GMP), to ensure drug safety and efficacy. The WHO, FDA, and EMA regulations influence supplier quality control and approval processes.

Procurement professionals must verify the suppliers’ certifications, WHO Good Manufacturing Practices (GMP) compliance, and product licensing status to mitigate risks of counterfeit or substandard supplies.

Supply Chain Challenges and Risk Factors
The supply chain for Gynazole-1 faces several challenges:

• Patent and licensing disputes influencing production rights.
• Regulatory delays impacting approval and distribution in certain regions.
• Manufacturing disruptions due to raw material shortages or geopolitical factors.
• Counterfeit risks, especially in unregulated markets, highlighting the need for thorough supplier validation.

Key Takeaways

• The primary supplier of Gynazole-1 is historically linked to the original patent holder, now often complemented by licensed generic manufacturers across the globe.
• Indian companies like Lupin and Hetero are significant players in producing and supplying generic butoconazole nitrate, expanding access in various markets.
• Regional regulatory requirements and licensing agreements greatly influence supplier options and market availability.
• Ensuring supplier compliance with rigorous quality standards is crucial to maintaining medication safety and efficacy.
• Geopolitical, regulatory, and supply chain risks necessitate diversification in sourcing strategies, especially in international procurement.

Conclusion
A comprehensive understanding of Gynazole-1’s suppliers underscores the importance of establishing relationships with reputable manufacturers and distributors to secure a reliable, high-quality supply. As the market evolves with patent expirations and generics proliferation, business professionals and healthcare providers must stay vigilant to regulatory changes, licensing agreements, and quality standards to optimize procurement and ensure patient safety.

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FAQs

1. Who is the original manufacturer of Gynazole-1?
The original patent holder was Watson Pharmaceuticals, which is now part of Allergan. They initially developed and marketed Gynazole-1 prior to patent expiry and licensing by generic companies.

2. Which countries are major suppliers of generic Gynazole-1?
India and China are key regions producing generic butoconazole nitrate, with companies such as Lupin and Hetero being prominent suppliers. These generics are distributed globally through regional licensing and partnerships.

3. How do regulatory agencies influence Gynazole-1 suppliers?
Regulatory agencies like the FDA, EMA, and local agencies enforce standards that suppliers must meet, including GMP compliance, licensing, and product approval before market entry, ensuring drug safety and quality.

4. What should healthcare providers consider when sourcing Gynazole-1?
Providers should verify supplier certifications, ensure the product’s regulatory approval, confirm GMP compliance, and prefer sources with transparent supply chains to mitigate counterfeit or substandard risks.

5. Are there regional differences in Gynazole-1 supply?
Yes. Availability and authorized suppliers vary by region, influenced by patent laws, licensing agreements, and local manufacturing capabilities, affecting access and pricing.

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References

[1] Allergan’s product licensing and historical corporate documents.
[2] Lupin Limited. "Product Portfolio." Lupin Corporate Website.
[3] Hetero Drugs. "Product Information and Global Reach." Hetero Pharmaceuticals.
[4] Sandoz. "Generics Portfolio." Sandoz Official Website.
[5] Mundipharma. "Global Licensing and Product Distribution." Mundipharma Corporate Reports.