Suppliers and packagers for vandazole

vandazole

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 Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806	NDA	Upsher-smith Laboratories, LLC	0245-0860-70	1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR	2005-10-04

Suppliers for the Pharmaceutical Drug: Vandazole

Last updated: July 30, 2025

Introduction

Vandazole, the trade name for metronidazole vaginal gel, is a topical antibiotic predominantly used to treat bacterial vaginosis (BV). As a critical treatment option for addressing vaginal infections, Vandazole has secured a place in gynecological pharmacotherapy. Ensuring a reliable supply chain for Vandazole involves understanding its approved manufacturers, authorized suppliers, and the regulatory landscape that governs its distribution. This report provides an in-depth analysis of key suppliers for Vandazole, examining manufacturing sources, licensing status, and market dynamics pertinent to stakeholders seeking dependable procurement channels.

Pharmaceutical Overview of Vandazole

Vandazole (metronidazole vaginal gel) is a prescription medication developed primarily by Pfizer Inc. and Theratechnologies, among others, depending on regional approvals. The formulation involves a 0.75% metronidazole gel designed for intravaginal application, delivering an effective dose with minimal systemic absorption. It is approved across numerous jurisdictions, including the U.S., Canada, and Europe, with approvals managed by respective regulatory agencies such as the FDA, Health Canada, and EMA.

Manufacturers and Authorized Suppliers

Pfizer Inc.

As the original developer and primary manufacturer, Pfizer maintains an extensive supply infrastructure for Vandazole. The company's global manufacturing network ensures broad distribution, especially in North America, Europe, and other key markets. Pfizer's production complies with cGMP (current Good Manufacturing Practices), ensuring quality control and regulatory compliance.

• Distribution Channels: Pfizer supplies Vandazole through its extensive distribution partners, authorized wholesalers, and directly to healthcare providers.
• Global Reach: Pfizer’s manufacturing facilities are located in multiple countries, including the U.S., Ireland, and others, facilitating supply continuity.

Theratechnologies

In some markets, Theratechnologies holds licensing agreements for Vandazole, either as the original licensee or through partnership arrangements. Their focus is more on North American markets, where they distribute through licensed pharmacy chains and specialty distributors.

Generic Manufacturers

Post patent expiry, several generic pharmaceutical companies have entered the Vandazole supply chain. These generic manufacturers produce metronidazole vaginal gel under licensing agreements or through regulatory approval pathways for bioequivalent products.

Company	Region	Licensing/Approval Status	Notes
Lupin Pharmaceuticals	USA, India	Approved generics	Supplies generic metronidazole gels.
Sun Pharmaceutical	India	Approved	Offers cost-effective alternatives.
Teva Pharmaceuticals	Worldwide	Approved	Prominent global generic supplier.

Authorized Distributors and Wholesalers

Major pharmacy chains, hospital procurement services, and online pharmacy networks source Vandazole primarily from authorized wholesalers affiliated with Pfizer and licensed generic manufacturers. These distributors maintain supply contracts, ensuring API and finished product quality standards adherence.

Regulatory and Supply Chain Considerations

• Supply Chain Robustness: The availability of Vandazole hinges on Pfizer's manufacturing capacity and the capacity of generic manufacturers.
• Regulatory Approvals: Only licensed suppliers holding regulatory approvals in respective jurisdictions can legally distribute Vandazole. Developing unauthorized supply channels risks legal penalties and safety concerns.

Regional Supply Dynamics

United States

Pfizer remains the dominant supplier, with approved generics available through multiple licensed manufacturers post patent expiration. The Drug Enforcement Administration (DEA) and FDA enforce strict compliance to ensure licensed procurement.

Canada

Health Canada authorizes multiple suppliers for Vandazole, including Pfizer and licensed generics. The shared market allows for competitive procurement.

European Union

EMA regulations permit multiple approved manufacturers. Several generic companies distribute metronidazole vaginal gels, often under authorized licensing agreements.

Emerging Markets

In regions such as Asia and Latin America, local pharmaceutical companies sometimes produce domestically sourced generics under license, subject to local regulatory approval processes. Supply stability varies significantly based on regional regulatory efficiency and manufacturing capacity.

Challenges and Opportunities in Vandazole Supply

Supply Chain Disruptions

Global supply chains face risks due to raw material shortages, manufacturing delays, and geopolitical restrictions, impacting product availability. The recent COVID-19 pandemic underscored the need for diversified manufacturing sources and strategic stockpiling.

Regulatory Barriers

Different regulatory standards across regions can delay approval or limit distribution, affecting supply continuity. Harmonizing regulatory pathways remains a strategic goal for manufacturers and regulators.

Market Demand and Pricing

Demand remains steady given Vandazole’s specificity for bacterial vaginosis. Competitive pricing from generic manufacturers introduces opportunities for more accessible treatment options but necessitates robust quality assurance.

Strategic Recommendations

• Diversify supplier base: Engage multiple licensed generic manufacturers to mitigate supply risks.
• Monitor regulatory landscapes: Stay compliant with evolving approvals and licensing requirements.
• Strengthen supply logistics: Collaborate with trusted distributors and optimize inventory management.

Conclusion

The supply landscape for Vandazole is characterized by a primary manufacturer—Pfizer—supported by a growing network of licensed generic producers post patent expiry, along with authorized distributors and wholesalers. Ensuring a reliable, compliant supply chain involves active supplier management, regulatory vigilance, and contingency planning. Stakeholders should prioritize partnerships with well-regarded licensed manufacturers, diversify sources, and stay abreast of regional regulatory developments to maintain consistent access to Vandazole.

Key Takeaways

• Pfizer remains the principal manufacturer of Vandazole, with a global manufacturing footprint ensuring widespread availability.
• Post patent expiration, several licensed generics—such as Lupin, Sun Pharma, and Teva—supply Vandazole, expanding market access and affordability.
• Maintaining supply stability requires multi-source procurement strategies, especially in emerging markets faced with regulatory and logistical challenges.
• Regional regulatory approvals influence supply availability; ongoing harmonization efforts could streamline distribution channels.
• Stakeholders should cultivate relationships with authorized suppliers and monitor global market conditions for supply continuity.

FAQs

1. Who are the primary suppliers of Vandazole?
   Pfizer is the original and primary manufacturer, with licensed generic producers like Lupin, Sun Pharma, and Teva supplying subsequent versions post patent expiry.

2. Are there authorized generics for Vandazole?
   Yes, multiple licensed generic manufacturers produce metronidazole vaginal gels under regulatory approval, expanding supply options globally.

3. How does regional regulation affect Vandazole supply?
   Regulatory approvals determine which suppliers can distribute Vandazole legally; discrepancies across regions can influence product availability.

4. What are the risks to Vandazole supply chain stability?
   Raw material shortages, manufacturing delays, regulatory changes, and geopolitical issues pose risks to a stable supply.

5. Can alternative suppliers be trusted for Vandazole?
   Only suppliers with proper licensing and regulatory approvals possess the legitimacy and quality assurance necessary for safe distribution.

Sources:

1. Pfizer Inc. Official Website
2. Health Canada Drug Product Database
3. European Medicines Agency (EMA)
4. FDA Approved Drugs Database
5. Global Market Analysis of Generic Pharmaceuticals

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