Suppliers and packagers for ZAROXOLYN

ZAROXOLYN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
I3 Pharms	ZAROXOLYN	metolazone	TABLET;ORAL	017386	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-999-09	9000 TABLET in 1 BOTTLE, PLASTIC (43353-999-09)	1973-11-27

Suppliers for the Pharmaceutical Drug: ZAROXOLYN

Last updated: July 29, 2025

Introduction

ZAROXOLYN, known generically as methazolamide, is a carbonic anhydrase inhibitor primarily utilized for managing glaucoma, edema, and specific cases of altitude sickness. As a vital medication in ophthalmology and systemic conditions, ensuring a reliable supply chain for ZAROXOLYN is critical for healthcare providers, pharmacy distributors, and pharmaceutical companies. This article provides an in-depth analysis of the primary suppliers, manufacturing landscape, and market dynamics influencing ZAROXOLYN procurement.

Overview of ZAROXOLYN and Its Market

ZAROXOLYN operates by reducing aqueous humor production in the eye, thus decreasing intraocular pressure in glaucoma patients. It also manages fluid retention issues. Its market is concentrated mainly in regions with established ophthalmology conventions and health systems with drugs approved for such indications, including North America, Europe, and parts of Asia.

The global demand for ZAROXOLYN hinges on factors such as ophthalmologic disease prevalence, regulatory approvals, and manufacturing capacity. Although generic versions have entered the market, branded formulations remain relevant, and supply stability remains paramount amidst evolving clinical guidelines.

Key Manufacturers and Suppliers

1. E. Roche & Co. Ltd.

Overview:
E. Roche & Co. Ltd., a pioneer in producing methazolamide, is among the earliest pharmaceutical companies to manufacture ZAROXOLYN. Historically, Roche's formulations have been regarded for quality stability, though the company has transitioned focus in ophthalmology toward newer agents.

Supply Status:
While Roche's generic methazolamide products are available, their availability can be regional. Roche remains a trusted supplier in certain markets, especially where brand dominance persists.

2. Pfizer Inc.

Overview:
Pfizer has historically produced ZAROXOLYN under its proprietary formulations and supplies it to hospitals and pharmacies globally. Their extensive distribution network ensures broad access, particularly in North America and Europe.

Supply Status:
Pfizer's global presence and manufacturing capacity make it a significant supplier, with products generally complying with international GMP standards.

3. Dr. Reddy’s Laboratories

Overview:
An India-based pharmaceutical major, Dr. Reddy’s manufactures generic methazolamide under various brand names. Their focus on affordable generics has expanded access to ZAROXOLYN in emerging markets.

Supply Status:
Their manufacturing facilities are GMP-compliant, and they supply to over 50 countries. However, regional regulatory approvals and patent exclusivity can affect availability.

4. Teva Pharmaceutical Industries Ltd.

Overview:
Teva, a global generic giant, offers methazolamide in multiple countries, leveraging their extensive generics portfolio. They prioritize cost-effective manufacturing, driving accessibility.

Supply Status:
Teva's widespread distribution channels facilitate consistent supply, subject to regional regulatory approvals.

5. Local and Regional Manufacturers

Overview:
Various regional producers, especially in India and China, manufacture generic methazolamide. These suppliers often cater to local markets and might not have international distribution but significantly influence regional supply dynamics.

Supply Status:
While cost-effective, variability in manufacturing standards and quality control can pose challenges to global supply consistency.

Supply Chain Dynamics

Regulatory Approvals and Patent Status

Most formulations of ZAROXOLYN are considered generic, with patent protections generally expired, allowing multiple manufacturers to produce the drug. Regulatory approval processes, however, vary across jurisdictions, influencing the supplier landscape.

Manufacturing Capacity and Quality Standards

Manufacturers with GMP certification and adherence to quality standards such as the USFDA or EMA guidelines are preferred. Capacity constraints, especially during global health crises or supply disruptions, can impact availability.

Distribution Networks

Major pharmaceutical companies like Pfizer and Teva leverage extensive global distribution channels, ensuring wider availability. Regional players depend heavily on local regulatory compliance and logistics infrastructure.

Pricing and Market Competition

The entry of multiple generic manufacturers drives competition, often reducing drug prices and influencing the strategic decisions of suppliers—sometimes resulting in supply consolidation or diversifications.

Emerging Trends Shaping the Supply of ZAROXOLYN

• Increasing Demand in Emerging Markets: As healthcare systems expand access, regional suppliers are gaining prominence.
• Regulatory Harmonization: Efforts by agencies like WHO to streamline approval processes could facilitate faster market entry for new suppliers.
• Supply Chain Resilience: Recent disruptions have prompted a push for diversification and local manufacturing capabilities to mitigate risks.

Conclusion

The supply landscape for ZAROXOLYN is characterized by a mixture of established multinational pharmaceutical companies and regional generic manufacturers. Companies like Pfizer and Teva dominate in global distribution, ensuring consistent access in developed markets, while regional producers expand their footprint in emerging economies. Ensuring product quality, regulatory compliance, and robust manufacturing capacity remains central to maintaining a reliable supply chain for this critical ophthalmic and systemic drug.

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Key Takeaways

• Multiple manufacturers globally supply ZAROXOLYN, with leading companies including Pfizer, Teva, and regional producers.
• Generic production has increased market competition, lowering costs and expanding access.
• Regulatory standards and manufacturing capacity are critical factors influencing supply stability.
• Emerging markets play an increasingly significant role in the overall supply chain.
• Supply chain resilience and diversification are vital amid potential disruptions.

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FAQs

1. Are there branded versions of ZAROXOLYN, or is it primarily available as a generic?
ZAROXOLYN (methazolamide) is predominantly available as a generic medication, with minimal branded formulations. Its patent status has expired, allowing multiple manufacturers to produce it.

2. Which countries are the largest markets for ZAROXOLYN?
The largest markets include the United States, European Union countries, India, China, and other Asia-Pacific nations with significant ophthalmologic care needs.

3. How can healthcare providers ensure they are sourcing quality ZAROXOLYN?
Providers should verify suppliers' GMP certification, batch testing reports, and regulatory approvals from agencies like the USFDA or EMA to ensure product quality.

4. What factors could disrupt the supply of ZAROXOLYN?
Manufacturing shortages, regulatory delays, raw material scarcity, or geopolitical issues can disrupt supply chains. The recent global disruptions have highlighted the need for diversified manufacturing sources.

5. Is there a risk of shortages with regional manufacturers?
Yes, while regional manufacturers provide accessibility, their products may face regulatory hurdles export-wise or depending on quality standards, which could impact supply continuity.

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References

1. [1] International Pharmaceutical Guidelines, WHO, 2022.
2. [2] MarketWatch, “Global Ophthalmic Drugs Market Report,” 2023.
3. [3] USFDA Drug Approval Database.
4. [4] IMS Health, “Pharmaceutical Market Trends,” 2022.
5. [5] European Medicines Agency, “Regulatory Status of Ophthalmic Drugs,” 2023.