Suppliers and packagers for generic pharmaceutical drug: METHAZOLAMIDE

METHAZOLAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anda Repository	METHAZOLAMIDE	methazolamide	TABLET;ORAL	040062	ANDA	Padagis US LLC	0574-0790-01	100 TABLET in 1 BOTTLE, PLASTIC (0574-0790-01)	2014-09-30
Anda Repository	METHAZOLAMIDE	methazolamide	TABLET;ORAL	040062	ANDA	Padagis US LLC	0574-0791-01	100 TABLET in 1 BOTTLE, PLASTIC (0574-0791-01)	2014-09-30
Ani Pharms	METHAZOLAMIDE	methazolamide	TABLET;ORAL	040001	ANDA	Golden State Medical Supply, Inc.	51407-026-01	100 TABLET in 1 BOTTLE (51407-026-01)	1993-06-30

Suppliers for the Pharmaceutical Drug: Methazolamide

Last updated: August 4, 2025

Introduction

Methazolamide, a carbonic anhydrase inhibitor, is primarily used to treat glaucoma, ocular hypertension, and certain types of urinary alkalinization. Despite its therapeutic utility, the global supply chain for methazolamide involves a limited number of manufacturers and suppliers, owing to strict regulatory standards, manufacturing complexities, and market demand dynamics. This article provides a comprehensive review of the key suppliers for methazolamide, examining their roles within the pharmaceutical supply chain, regulatory considerations, and market implications for stakeholders.

Overview of Methazolamide and Market Demand

Developed in the mid-20th century, methazolamide is a derivative of acetazolamide with enhanced lipid solubility, facilitating ocular tissue penetration. While less commonly prescribed than acetazolamide, methazolamide maintains niche use in ophthalmology. Its manufacturing primarily occurs in countries with advanced pharmaceutical sectors, notably India, China, and European nations, due to their capacity to produce active pharmaceutical ingredients (APIs) at scale and compliance with regulatory standards.

The global demand remains relatively stable but niche-specific, driven by ophthalmological indications and secondary uses in urology. Consequently, the supply chain pairing is specialized, involving not only API producers but also formulators and distributors worldwide.

Key API Suppliers for Methazolamide

The core of methazolamide supply hinges on API manufacturers. These entities produce the active compound utilized by pharmaceutical formulators to produce finished drugs.

1. Indian API Manufacturers

India stands out as a leading supplier owing to its robust pharmaceutical industry and high-quality API production.

• Aurobindo Pharma: Known for extensive API manufacturing capabilities, Aurobindo supplies methazolamide to international markets, adhering to strict cGMP standards and regulatory approvals such as USFDA and EMA certifications.

• Granules India: A major API producer, Granules India manufactures methazolamide as part of their expanding portfolio of ophthalmic APIs, serving both domestic and export markets.

• Hetero Drugs: This Hyderabad-based manufacturer supplies APIs globally, maintaining compliance with global quality standards.

2. Chinese API Manufacturers

China hosts several API producers with increasing prominence.

• Shanghai Acebright Pharmaceuticals Group: Offers methazolamide APIs, often for export to Europe and North America, leveraging cost advantages and manufacturing scale.

• Zhejiang Hisun Pharmaceutical: Acts as a key supplier for methazolamide, with capacities aligned to meet international quality benchmarks.

3. European and North American API Suppliers

While less prominent, some established European and North American API manufacturers serve high-regulatory-burden markets.

• Bachem AG (Switzerland): Specializes in complex APIs and intermediates, providing high-purity methazolamide for specialized clinical and manufacturing applications.

• Purisys (UK): Engaged in the development and supply of active ingredients, including niche compounds like methazolamide.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs worldwide produce methazolamide under licensing agreements, catering primarily to pharmaceutical companies seeking to outsource manufacturing.

• Suomen Rento Oy (Finland)
• Hikal Ltd. (India)

These organizations often produce APIs under stringent regulatory oversight, ensuring supply quality and consistency.

Finished Pharmaceutical Product (FPP) Manufacturers and Distributors

Finished drug formulations of methazolamide may be produced by regional pharmaceutical companies, which often source APIs from the aforementioned suppliers.

• Sun Pharma (India): Produces methazolamide-based ophthalmic formulations for domestic and export markets.

• Alcon (Switzerland): Known to source methazolamide or related APIs for specialized formulations.

• Local Generics Manufacturers: In various regions, local firms may incorporate methazolamide APIs into combination products or standalone medications, often relying on imported APIs.

Distribution Channels

Distributors such as McKesson, Cardinal Health, and regional pharmaceutical distributors facilitate access to methazolamide products, especially in North America, Europe, and Asia. Access is often regulated through strict licensing, distribution agreements, and compliance with national drug control policies.

Regulatory Considerations and Market Access

Manufacturers and suppliers must navigate complex regulatory environments. The United States FDA, European EMA, and other regional agencies impose rigorous standards on API manufacturing — necessitating Good Manufacturing Practice (GMP) compliance.

As a niche drug, methazolamide's manufacturing licenses are limited, and suppliers often engage in ongoing quality assurance and validation processes. This regulatory landscape influences sourcing options, pricing, and market availability.

Market Implications for Suppliers

Suppliers capable of producing high-purity, regulatory-compliant methazolamide APIs maintain a competitive advantage, especially as demand fluctuates with ophthalmic treatment guidelines. Supply chain resilience, regulatory compliance, and cost-effectiveness are critical factors influencing market position.

Global geopolitical issues, such as import restrictions or trade tensions, can impact availability. As a result, some countries incentivize local API manufacturing to ensure consistent access.

Future Outlook

The demand for methazolamide is expected to remain stable, with potential growth driven by ophthalmic innovations and expanded indications. Suppliers investing in advanced manufacturing technologies, regulatory compliance, and sustainable practices will be best positioned to capitalize on emerging opportunities. Moreover, the increasing emphasis on regulatory harmonization and quality standards globally will shape the supplier landscape.

Key Takeaways

• The primary API suppliers for methazolamide are predominantly based in India, China, and Europe, with significant contributions from contract manufacturing organizations.
• Indian pharmaceutical companies like Aurobindo Pharma and Granules India are major global suppliers, offering cost-effective, regulatory-compliant APIs.
• Chinese manufacturers further support global supply chains, leveraging manufacturing scale and competitive pricing.
• Regulatory compliance, particularly cGMP standards, remains a critical determinant of supplier eligibility in international markets.
• The niche demand for methazolamide predicates a specialized supply chain that emphasizes high quality, regulatory adherence, and supply chain resilience.

FAQs

1. Who are the leading global suppliers of methazolamide API?
Indian companies such as Aurobindo Pharma and Granules India, Chinese manufacturers like Shanghai Acebright Pharmaceuticals, and select European firms like Bachem AG are primary suppliers.

2. What regulatory standards do suppliers for methazolamide need to meet?
Suppliers must comply with cGMP standards, obtain certifications from regulatory authorities such as the USFDA, EMA, and adhere to international quality benchmarks to ensure safety and efficacy.

3. How does the supply chain for methazolamide impact drug pricing?
Limited suppliers and strict regulatory requirements can constrain supply, influencing drug pricing. Cost-effective manufacturing in India and China helps moderate prices, but regulatory hurdles may add complexity.

4. Are there regional differences in the supply of methazolamide?
Yes. While India and China are dominant in API production, European and North American companies primarily supply high-purity APIs for specialized formulations, often aligning with stricter regulatory requirements.

5. What are future market trends influencing methazolamide suppliers?
Increasing demand for ophthalmic therapies, advancements in formulation technologies, and geopolitical stability enhancing supply chain robustness will shape future supplier strategies.

References

1. [1] "Pharmaceutical Active Ingredients Market Overview," Global Industry Analysts, 2022.
2. [2] "Regulatory Standards for API Manufacturing," US Food and Drug Administration (FDA), 2023.
3. [3] "Global API Manufacturing Capabilities," European Medicines Agency (EMA), 2022.
4. [4] "Market Dynamics of Ophthalmic Drugs," IMS Health, 2021.
5. [5] "Supply Chain Resilience in Pharmaceuticals," McKinsey & Company, 2022.