Suppliers and packagers for AZOPT

AZOPT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816	NDA	Novartis Pharmaceuticals Corporation	0078-0722-10	1 BOTTLE in 1 CARTON (0078-0722-10) / 10 mL in 1 BOTTLE	1998-04-30
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6014-70	1 BOTTLE, PLASTIC in 1 CARTON (0781-6014-70) / 10 mL in 1 BOTTLE, PLASTIC	2021-03-08
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6014-85	1 BOTTLE, PLASTIC in 1 CARTON (0781-6014-85) / 15 mL in 1 BOTTLE, PLASTIC	2021-03-08

Suppliers for the Pharmaceutical Drug: AZOPT

Last updated: August 1, 2025

Overview of AZOPT

AZOPT, commercially known as brinzolamide ophthalmic suspension, is a topical carbonic anhydrase inhibitor primarily prescribed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. Approved by the U.S. Food and Drug Administration (FDA) in 2005, AZOPT is marketed by Alcon, a subsidiary of Novartis. As a specialized ophthalmic drug, its production involves a complex supply chain comprising active pharmaceutical ingredient (API) providers, formulation manufacturers, and packaging vendors.

Understanding AZOPT's suppliers is vital for stakeholders across the pharmaceutical value chain, including healthcare providers, investors, and competitors. This report details its primary suppliers, global manufacturing landscape, and significant factors influencing its sourcing.

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Active Pharmaceutical Ingredient (API) Suppliers

Brinzolamide: The Core API

The fundamental component of AZOPT is brinzolamide, a sulfonamide derivative that inhibits carbonic anhydrase enzymes. The API's production is concentrated among specialized chemical manufacturers capable of synthesizing high-purity compounds consistent with regulatory standards.

Leading API Suppliers

1. Novartis / Alcon's In-house API Production

   Alcon, under Novartis, maintains integrated API manufacturing facilities, particularly within its global manufacturing network in countries like Switzerland, the U.S., and India. This vertical integration ensures control over API quality and supply continuity for AZOPT. The company’s global manufacturing strategy encompasses in-house synthesis, especially considering the high-value nature of ophthalmic APIs.

2. Contract Manufacturing Organizations (CMOs)

   When in-house production is insufficient or strategic, Alcon partners with specialized CMOs. These external entities are often selected based on regulatory compliance, capacity, and quality standards.

   • Hikal Ltd. (India): Known for custom synthesis of active pharmaceutical ingredients, Hikal supplies various APIs globally, including derivatives like brinzolamide.

   • Siegfried AG (Switzerland): An established CMO with capabilities in small-molecule synthesis, Siegfried may supply completed intermediates or APIs for ophthalmic formulations.

   • Lannette International (India): A manufacturer recognized for high-purity specialty chemicals, potentially serving as an API supplier for ophthalmic drugs.

3. Generic Manufacturers

   Post-patent expiration or in markets with biosimilar or generic competition, other entities may produce brinzolamide APIs under licensing agreements, although for AZOPT, Alcon retains primary sourcing rights.

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Formulation and Finished Dosage Form Suppliers

While Alcon primarily manages the formulation, some regional manufacturing partners are involved in producing AZOPT ophthalmic suspensions:

• Alcon Manufacturing Facilities

  Alcon's global manufacturing sites in the U.S., Switzerland, and India handle formulation, filling, and packaging under strict quality controls aligning with GMP standards.

• Third-party Contract Packagers

  For packaging, Alcon collaborates with specialized sterile-packaging providers, especially in India and Europe, to meet regional distribution needs.

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Global Manufacturing Landscape and Supply Chain Dynamics

Manufacturing Locations

• United States: Facilities in Fort Worth, Texas, produce both APIs and formulations, leveraging robust regulatory oversight.
• Switzerland: Alcon's headquarters and manufacturing units benefit from advanced infrastructure, emphasizing quality.
• India and China: Increasingly significant, these regions supply intermediates and finished products owing to cost efficiencies and growing capacity.

Supply Chain Challenges

• Regulatory Compliance: API and formulation suppliers must adhere to stringent cGMP standards. Variability in regulatory requirements across countries can impact supplier selection.
• Raw Material Scarcity: Ensuring a consistent supply of starting materials and chemical precursors is complex due to geopolitical issues or supply disruptions.
• Quality Assurance: Maintaining high purity levels for ophthalmic APIs is imperative to prevent ocular toxicity, constraining supplier choices to those with proven quality records.

Strategic Importance of Supply Chain Diversification

Given the critical nature of ophthalmic drugs like AZOPT, Alcon emphasizes supplier diversification to mitigate risks related to supply disruption, quality deterioration, or geopolitical tensions—particularly in regions with developing manufacturing capacity.

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Key Factors Influencing Supplier Selection

• Regulatory Track Record: Suppliers with an established history of compliant manufacturing processes.
• Capacity and Scalability: Ability to meet surging demand and supply stability.
• Cost Efficiency: Competitive pricing within the constraints of quality and regulatory compliance.
• Supply Chain Resilience: Proven track record of delivering on time amidst logistical or geopolitical challenges.
• Technological Capabilities: Expertise in synthesizing complex molecules with high purity requirements.

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Future Outlook and Emerging Trends

The supply landscape for AZOPT is evolving toward increased regional manufacturing in India and China, driven by cost pressures and regulatory harmonization. Alcon’s strategic partnerships aim to secure diversified, high-quality API sources while investing in capacity expansions for APIs and formulations.

Additionally, advancements in bioengineering and synthetic chemistry may influence future API sourcing, enabling more sustainable and scalable production methods. The ongoing global emphasis on supply chain resilience and compliance underscores the need for continuous supplier evaluation and diversification.

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Key Takeaways

• AZOPT's core API, brinzolamide, is predominantly supplied by Alcon's integrated manufacturing facilities, supplemented by qualified CMOs in India and Switzerland.
• Regional manufacturing hubs in India and China are increasingly vital to meet global demand efficiently.
• Supply chain stability hinges on strict regulatory compliance, quality assurance, and geopolitical risk management.
• Diversification across multiple suppliers enhances supply resilience, especially vital amid global disruptions.
• Strategic investment in advanced synthesis methods and regional manufacturing will likely shape the future AZOPT supply chain.

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FAQs

1. Who are the primary API suppliers for AZOPT?
Alcon primarily produces brinzolamide internally, complemented by partnerships with CMOs such as Hikal (India) and Siegfried (Switzerland), ensuring high-quality supply.

2. How does Alcon manage supply chain risks for AZOPT?
By diversifying suppliers across regions, maintaining in-house manufacturing, and adhering to strict quality standards, Alcon mitigates risks related to supply disruptions.

3. Are there generic equivalents of AZOPT, and who supplies their APIs?
While various generics exist, they typically source APIs from local chemical manufacturers in India and China, with the original API production mainly by licensed or in-house suppliers.

4. What factors influence the choice of API suppliers for ophthalmic drugs?
High purity standards, regulatory compliance, manufacturing capacity, cost, and logistical reliability are key determinants.

5. What trends are shaping AZOPT's supply chain moving forward?
Increasing regional manufacturing, technological advancements in synthesis, and heightened focus on supply chain resilience are prominent trends.

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Sources
[1] U.S. Food and Drug Administration (FDA). AZOPT Prescribing Information.
[2] Novartis and Alcon official websites.
[3] Industry reports on pharmaceutical supply chains and API manufacturing.
[4] Market analyses on ophthalmic drug production in India and China.