BRIMONIDINE TARTRATE; BRINZOLAMIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-25	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER	2013-05-06
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-27	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER	2013-05-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Brimonidine tartrate and brinzolamide are critical pharmacological agents used primarily in the treatment of glaucoma and ocular hypertension. Their global demand underscores the importance of reliable suppliers capable of ensuring consistent quality, regulatory compliance, and supply chain stability. This report analyzes the key suppliers for these drugs, the landscape of manufacturing capacity, and strategic considerations for pharmaceutical companies and healthcare providers seeking dependable sourcing options.

Overview of Brimonidine Tartrate and Brinzolamide

Brimonidine Tartrate: An alpha-2 adrenergic receptor agonist, brimonidine reduces intraocular pressure by decreasing aqueous humor production and increasing uveoscleral outflow. It is available in various formulations and is a frontline agent in glaucoma management [1].

Brinzolamide: A carbonic anhydrase inhibitor, brinzolamide lowers intraocular pressure by reducing aqueous humor secretion. It is commonly used either alone or in combination therapies for glaucoma [2].

The effective production of both drugs depends on complex chemical synthesis, which involves proprietary manufacturing processes and strict regulatory standards.

Major Suppliers for Brimonidine Tartrate

1. Allergan (AbbVie Inc.)

Overview: Historically, Allergan was a leading manufacturer with a broad portfolio including brimonidine tartrate formulations, notably Alphagan P.
Market Role: As of 2020, AbbVie acquired Allergan's ophthalmology portfolio, continuing production and distribution of these drugs.
Manufacturing Capacity: AbbVie maintains a vertically integrated manufacturing process across multiple facilities globally, ensuring robust supply channels [3].

2. Santen Pharmaceutical

Overview: A significant Japanese ophthalmic pharmaceutical company with manufacturing capabilities encompassing brimonidine tartrate.
Market Role: Santen supplies both domestic and international markets, often providing generic formulations.
Key Advantages: Known for high-quality production standards aligned with Japanese Good Manufacturing Practice (GMP) regulations [4].

3. Dr. Reddy's Laboratories

Overview: An Indian API and pharmaceutical company producing both the active ingredient and finished formulations.
Capacity: Reddy’s has invested heavily in GMP-certified manufacturing sites with considerable capacity for brimonidine tartrate [5].

4. Aurobindo Pharma

Overview: An Indian pharmaceutical major with significant API manufacturing capabilities and formulation production.
Market Role: Supplies generic brimonidine tartrate products globally, often at competitive prices [6].

Leading Suppliers for Brinzolamide

1. Alcon (Novartis Group)

Overview: The original developer of brinzolamide (marketed as Azopt), Alcon remains the primary manufacturer and global leader.
Market Role: Dominates the commercial landscape with extensive manufacturing infrastructure and distribution networks.
Strategic Position: As a dedicated ophthalmic specialist, Alcon’s high-quality standards and R&D investments secure their leadership position [7].

2. Sun Pharmaceutical Industries

Overview: An Indian multinational that produces generic ophthalmic drugs including brinzolamide.
Capacity: Operates GMP-compliant manufacturing plants capable of meeting international quality benchmarks.
Market Role: Supplies both branded and generic formulations across various regions [8].

3. Zydus Cadila

Overview: An Indian pharmaceutical company with a growing portfolio of ophthalmic generics.
Manufacturing: Capable of producing both API and finished formulations for brinzolamide under GMP conditions.
Regional Reach: Focused on expanding its footprint in North America and Europe [9].

4. Aurobindo Pharma

Overview: Also supplies brinzolamide, leveraging its API production capabilities.
Market Reach: Distributes generics across the US, Europe, and emerging markets [6].

Emerging and Contract Manufacturing Options

Beyond the established players, several Contract Manufacturing Organizations (CMOs) specialize in ophthalmic APIs and formulations, supporting supply chain flexibility and capacity scaling. Examples include Syncorp and Aesica Pharmaceuticals, which produce APIs or finished dosages under strict GMP adherence [10].

Key Considerations in Supplier Selection

Regulatory Compliance: Suppliers must adhere to GMP standards (e.g., US FDA, EMA) to ensure legal compliance and product safety [11].
Quality Assurance: Certification and rigorous quality control processes are essential to maintain efficacy and safety.
Supply Chain Stability: Geographic diversification mitigates risks associated with geopolitical issues, pandemics, or raw material shortages.
Cost and Lead Times: Competitive pricing and responsive logistics impact procurement strategies.
Traceability: Transparency and traceability in sourcing holdings are crucial, especially amid rising regulatory scrutiny.

Market Trends and Strategic Implications

The ongoing patent expirations and the rise of generic manufacturers have expanded the supplier landscape but also increased competition. Pharmaceutical firms are increasingly engaging in strategic sourcing agreements, licensing deals, and joint ventures with Asian suppliers to ensure cost efficiency and supply assurance [12].

In tandem, regulatory harmonization efforts aim to streamline approvals for APIs such as brimonidine tartrate and brinzolamide, further facilitating global distribution and manufacturing expansion [13].

Conclusion

The landscape for suppliers of brimonidine tartrate and brinzolamide is characterized by a mix of established multinational corporations and robust Indian manufacturers. Leaders like Alcon and Novartis (through Alcon) dominate the market, supported by a wide global distribution network and significant R&D investments. Meanwhile, Indian companies such as Dr. Reddy’s, Aurobindo, and Sun Pharma offer competitive options, especially in cost-sensitive markets.

Supply chain resilience depends increasingly on diversifying sources, ensuring strict regulatory adherence, and fostering long-term strategic partnerships with trusted manufacturers.

Key Takeaways

Market Leaders: Alcon and Novartis are the primary suppliers for brinzolamide, while Allergan/AbbVie remains dominant in brimonidine tartrate.
Robust Opportunities in India: Indian firms like Dr. Reddy’s and Aurobindo offer high-quality, cost-effective options, consolidating their global presence.
Regulatory Vigilance: Compliance with GMP standards (FDA, EMA, local authorities) remains critical to ensure uninterrupted supply.
Diversification Strategies: Procurement from multiple suppliers reduces dependency risks and enhances supply chain stability.
Emerging CMOs: Contract manufacturing organizations are increasingly supporting capacity expansion, especially for API production.

FAQs

1. Who are the top global suppliers for brimonidine tartrate?
The leading global manufacturers include Allergan/AbbVie, Santen Pharmaceutical, Dr. Reddy’s Laboratories, and Aurobindo Pharma, with AbbVie maintaining a dominant market share post-2019 acquisition of Allergan’s ophthalmic portfolio.

2. Which companies are the primary producers of brinzolamide?
Alcon (Novartis) remains the principal manufacturer, complemented by strong competition from Indian companies such as Sun Pharma, Zydus Cadila, and Aurobindo Pharma.

3. Are generic suppliers of these drugs reliable?
Yes, provided they comply with international GMP standards, have robust quality assurance protocols, and maintain supply chain transparency.

4. What are the risks associated with sourcing from emerging markets?
Potential risks include variability in regulatory standards, intellectual property concerns, supply chain disruptions, and quality control challenges—mitigated through rigorous qualification and audits.

5. How is the landscape expected to evolve in the coming years?
Increased manufacturing capacity through global expansion, technological innovations, and regulatory harmonization are projected to enhance supply resilience and reduce costs.

References

[1] "Brimonidine Tartrate," Drugs.com, 2023.
[2] "Brinzolamide," Lancet Global Health, 2022.
[3] AbbVie. "Annual Report," 2022.
[4] Santen Pharmaceutical. "Corporate Overview," 2023.
[5] Dr. Reddy’s Laboratories. "Pipeline and Capacity," 2023.
[6] Aurobindo Pharma. "Global Operations," 2023.
[7] Alcon. "Product Portfolio," 2023.
[8] Sun Pharmaceutical Industries. "Ophthalmic Portfolio," 2022.
[9] Zydus Cadila. "Ophthalmic Drugs," 2023.
[10] "Contract Manufacturing Trends," Pharmaceutical Technology, 2021.
[11] "GMP Standards in API Manufacturing," WHO Guidelines, 2020.
[12] "Market Dynamics of Ophthalmic Generics," IQVIA Reports, 2022.
[13] "Regulatory Pathways for Ophthalmic APIs," EMA, 2023.

Suppliers and packagers for generic pharmaceutical drug: BRIMONIDINE TARTRATE; BRINZOLAMIDE