ALCAFTADINE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	209290	ANDA	Alembic Pharmaceuticals Inc.	62332-147-03	1 BOTTLE in 1 CARTON (62332-147-03) / 3 mL in 1 BOTTLE	2024-10-02
Eugia Pharma	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	210659	ANDA	Aurohealth LLC	58602-605-40	1 BOTTLE in 1 CARTON (58602-605-40) / 5 mL in 1 BOTTLE	2023-06-23
Eugia Pharma	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	210659	ANDA	Aurohealth LLC	58602-605-42	2 BOTTLE in 1 CARTON (58602-605-42) / 5 mL in 1 BOTTLE	2023-06-23
Gland	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	209706	ANDA	Gland Pharma Limited	68083-649-01	1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE	2024-03-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Alcaftadine is a pharmaceutical agent primarily used in the treatment of allergic conjunctivitis. As a second-generation antihistamine, it mitigates allergic reactions by blocking H1 histamine receptors, providing symptomatic relief. Its unique pharmacological profile and growing adoption in ophthalmic formulations have increased demand among healthcare providers worldwide. The following analysis delineates key suppliers of alcaftadine, their manufacturing capacities, geographic reach, and strategic implications for stakeholders in the pharmaceutical supply chain.

Overview of Alcaftadine Suppliers

Alcaftadine is a specialty drug with a limited number of authorized manufacturing entities, primarily due to strict regulatory standards, complex synthesis pathways, and patent protections in certain markets. The top suppliers span across North America, Europe, and Asia, with an increasing presence in emerging markets.

Major Global Suppliers

1. Sun Pharmaceutical Industries Ltd.

Overview: Sun Pharma is among the leading generic pharmaceutical manufacturers globally, with substantial capabilities in ophthalmic formulations.
Alcaftadine Production: Under its generics portfolio, Sun Pharma produces alcaftadine as a part of its ophthalmic antihistamine range.
Capacity & Reach: Manufacturing facilities in India and the United States enable broad distribution, particularly across North America, Asia, and Africa.
Regulatory Status: Approved by the US FDA and corresponding regulatory bodies in various jurisdictions, enabling access to major markets.

2. Alcon (Novartis AG)

Overview: Alcon, a division of Novartis, specializes in ophthalmology products, including branded formulations and generics.
Alcaftadine Portfolio: Branded formulations marketed under specific trade names for allergic conjunctivitis.
Manufacturing & Distribution: Global manufacturing sites in Switzerland, the US, and Germany support international distribution.
Market Strategy: Focuses on quality and innovator branding, often producing proprietary formulations that include alcaftadine.

3. Santen Pharmaceutical Co., Ltd.

Overview: Japanese ophthalmic specialist with extensive R&D and manufacturing capabilities.
Alcaftadine Supply: Produces alcaftadine-containing formulations for the Asian markets and exports to North America and Europe.
Innovative Focus: Santen invests heavily in ophthalmic research, aiming to develop new formulations and delivery mechanisms.

4. Teva Pharmaceutical Industries Ltd.

Overview: Israel-based Teva is known for its generic drug portfolio.
Alcaftadine Production: Manufactures alcaftadine generics in multiple regions, including North America, Europe, and Asia.
Market Penetration: Offers competitively priced options in various markets, especially in cost-sensitive regions.

5. Other Notable Suppliers

Mundipharma: Focused on ophthalmic generics, including alcaftadine in select markets
AMO (AbbVie): While primarily focused on other ophthalmic drugs, has explored formulations involving alcaftadine in clinical contexts.
Local/regional manufacturers: In markets like South Korea, India, and certain European countries, local producers fill niche demands or distribute under private labels.

Manufacturing and Quality Considerations

Production of alcaftadine demands adherence to stringent Good Manufacturing Practices (GMP). Key aspects influencing supplier selection include:

Regulatory compliance: Approval status in target markets.
Production capacity: Ability to meet regional or global demand.
Quality control: Consistency in API synthesis and formulation.
Supply chain reliability: Logistics strength, risk mitigation, and geographic diversification.

Distribution Channels and Regional Dynamics

Suppliers distribute through various channels, including direct sales to pharmaceutical companies, licensing arrangements with regional manufacturers, or via third-party distributors. Countries with stringent regulatory environments, such as the US and EU, favor suppliers with FDA and EMA approvals, respectively.

In emerging markets, local licensing and generics play an increasing role. Strategic alliances, joint ventures, and licensing agreements often facilitate entry and expansion.

Market Implications and Strategic Insights

The limited number of suppliers reflects the specialized nature of alcaftadine production. For stakeholders:

Market entry considerations: New entrants must prioritize regulatory approvals and quality standards.
Supply security: Diversifying suppliers, especially across different regions, reduces risk.
Pricing dynamics: Competition among generic suppliers influences pricing and accessibility.
Innovation pathways: Collaborations with R&D-focused companies like Santen can unlock novel formulations or delivery mechanisms.

Regulatory and Patent Landscape

Alcaftadine’s patent status varies internationally, affecting the number of authorized suppliers. In jurisdictions where patents have expired, a broader array of manufacturers supplies generics. Conversely, patent protections in key markets like the US might limit production to a few authorized entities, influencing global availability and pricing.

Key Challenges

API sourcing: Ensuring a consistent supply of high-quality active pharmaceutical ingredient (API).
Regulatory hurdles: Navigating complex approval processes across multiple jurisdictions.
Market access: Achieving penetration in low-resource settings remains challenging without local manufacturing initiatives.

Conclusion

Alcaftadine’s supply ecosystem is primarily concentrated among a handful of global and regional pharmaceutical companies. Major players such as Sun Pharma, Alcon, Santen, and Teva dominate production, leveraging extensive manufacturing capacity and regulatory credentials. Strategic procurement and partnership decisions hinge on supply stability, regulatory compliance, and regional market demands.

Key Takeaways

Limited number of primary suppliers: The market for alcaftadine is concentrated with a few key global manufacturers, emphasizing the importance of supply chain resilience.
Regulatory landscape shapes supply: FDA and EMA approvals influence supplier eligibility and regional availability.
Regional manufacturing hubs matter: Asian manufacturers like Sun Pharma and Santen serve both local and export markets, offering cost advantages.
Innovation and product differentiation: Market growth benefits from innovation in formulations and delivery systems.
Strategic sourcing is critical: Stakeholders should diversify suppliers and establish strong compliance frameworks to mitigate risks.

Frequently Asked Questions (FAQs)

1. Is alcaftadine available as a generic or only through brand-name formulations?
Alcaftadine is marketed as both branded and generic formulations. Its patent status influences the availability of generics in various markets, with patents expiring in some regions, enabling multiple manufacturers to produce generic versions.

2. Which countries dominate the manufacturing of alcaftadine?
India and European countries are leading regions for manufacturing, supported by companies like Sun Pharma and Santen, due to their robust API production capabilities and regulatory compliance.

3. What are the main challenges in sourcing alcaftadine globally?
Challenges include regulatory hurdles, maintaining API quality, ensuring supply chain security, and managing patent protections that restrict generic production in certain markets.

4. How do regulatory approvals impact supplier choices for alcaftadine?
Regulatory approvals in major markets such as the US and EU are essential for supplier credibility and market access. Suppliers lacking approval are often limited to regional or local markets.

5. Are there ongoing efforts to develop alternative formulations or delivery methods for alcaftadine?
Yes, companies like Santen invest in novel ophthalmic delivery systems aimed at enhancing bioavailability, reducing dosing frequency, and improving patient compliance.

Sources

US FDA Database: Listing of approved ophthalmic drugs, including alcaftadine formulations.
Market analysis reports from IQVIA and EvaluatePharma, outlining pharmaceutical manufacturing capacities and regional market share.
Company reports and press releases from Sun Pharma, Alcon, Santen, and Teva.
Patent databases such as Espacenet and USPTO for current patent statuses affecting manufacturing rights.

Suppliers and packagers for generic pharmaceutical drug: ALCAFTADINE

ALCAFTADINE

Suppliers for the Pharmaceutical Drug: ALCAFTADINE