Suppliers and packagers for generic pharmaceutical drug: KETOTIFEN FUMARATE

KETOTIFEN FUMARATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038-05	1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE	2013-09-03
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038-10	1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE	2013-09-03
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA AUTHORIZED GENERIC	Rugby Laboratories	0536-1252-40	1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER	2020-09-18
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Target Corporation	11673-064-05	1 BOTTLE in 1 CARTON (11673-064-05) / 5 mL in 1 BOTTLE	2014-01-02

Suppliers for the Pharmaceutical Drug: Ketotifen Fumarate

Last updated: July 29, 2025

Introduction

Ketotifen fumarate, a selective antihistamine and mast cell stabilizer, is widely used to prevent asthma, allergic conjunctivitis, and other hypersensitivity conditions. Its growing demand across global markets highlights the importance of a reliable supply chain. This report examines the key suppliers manufacturing ketotifen fumarate, analyzing their capabilities, geographic distribution, regulatory status, and market positioning to inform pharmaceutical companies, distributors, and stakeholders involved in procurement and strategic sourcing.

Overview of Ketotifen Fumarate

Ketotifen fumarate is marketed under various brand names and as a generic drug. It functions primarily as a non-competitive antihistamine, blocking H1 receptors, and stabilizes mast cells to prevent the release of inflammatory mediators. The compound's stability, safety profile, and efficacy have cemented its role in allergy management.

Global demand is projected to increase owing to rising allergy prevalence, especially in emerging economies. Ensuring uninterrupted supply necessitates working with established manufacturers adhering to international quality standards such as Good Manufacturing Practice (GMP).

Leading Suppliers and Manufacturers

1. Novartis

Overview:
Novartis is a prominent Swiss multinational with a significant presence in the allergy medication segment. It manufactures authentic ketotifen fumarate formulations and active pharmaceutical ingredients (APIs).

Capabilities:

• Compliance with strict GMP standards.
• Extensive R&D and quality assurance systems.
• Supply chain spanning North America, Europe, and Asia.

Market Position:
As a pioneer in allergy therapeutics, Novartis supplies both branded and generic ketotifen fumarate products. Their global reach ensures consistent supply to major markets, maintaining regulatory approvals across various jurisdictions.

2. Sandoz (A Novartis division)

Overview:
Sandoz specializes in generic pharmaceuticals and APIs, including ketotifen fumarate.

Capabilities:

• Large-scale API manufacturing facilities in India and Europe.
• ISO-certified production processes.
• Focused on affordable generics for emerging markets.

Market Position:
Sandoz's manufacturing capabilities enable cost-effective supply, particularly for countries with price-sensitive markets. Their extensive distribution network secures their role as a key supplier globally.

3. Alchemy Laboratories

Overview:
An Indian pharmaceutical company known for producing APIs and intermediates for antihistamines.

Capabilities:

• GMP-certified facilities approved by the FDA and other regulatory bodies.
• Specialization in antihistamine APIs; offers ketotifen fumarate at competitive prices.
• Established export channels to North America, Europe, and Asia.

Market Position:
Alchemy has positioned itself as a reliable source of high-quality ketotifen fumarate for global generic manufacturers, capitalizing on India's infrastructure to supply cost-effective APIs.

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

Overview:
A leading Chinese pharmaceutical manufacturer, Zhejiang Hisun produces various APIs for cardiovascular and allergy indications.

Capabilities:

• Advanced R&D for process optimization.
• Compliance with international quality standards.
• Dedicated production lines for APIs like ketotifen fumarate.

Market Position:
Chinese API manufacturers like Hisun are increasingly expanding their footprints in international markets, offering competitive pricing and scaling production capacities for ketotifen fumarate.

5. Jiangsu Hengrui Medicine Co., Ltd.

Overview:
A top-tier Chinese pharmaceutical firm with a diversified product portfolio, including APIs.

Capabilities:

• GMP and ISO certification.
• Robust supply chain mechanisms.
• Focus on quality control and continuous process improvement.

Market Position:
Jiangsu Hengrui actively supplies ketotifen fumarate APIs to both domestic and international markets, emphasizing affordable pricing without compromising quality.

6. Others: Domestic and Regional Manufacturers

Smaller, regional manufacturers in India, Turkey, and Eastern Europe also produce ketotifen fumarate, often catering to specific markets with customized formulations. These companies typically fulfill niche or regional demand but may not meet stringent global regulatory standards without partnering or accreditation.

Regulatory and Quality Considerations

The reputation of ketotifen fumarate suppliers hinges on compliance with international standards such as:

• GMP Certification: Ensures manufacturing processes meet quality benchmarks.
• ISO Certification: Validates quality management systems.
• Regulatory Approvals: Suppliers should hold approvals from agencies like the US FDA, EMA, or PMDA depending on target markets.

Due diligence includes verifying batch-to-batch consistency, stability data, and adherence to pharmacopoeial monographs (USP, EP, BP).

Market Dynamics Influencing Supplier Selection

• Price Sensitivity: Generic suppliers from India and China dominate due to competitive pricing.
• Quality Assurance: Manufacturers with established certifications and regulatory approvals are preferred.
• Supply Chain Reliability: Producers with large-scale facilities, diversified sourcing, and contingency planning ensure consistent supply.
• Geographical Reach: Suppliers with robust international distribution channels facilitate timely delivery across different regions.

Emerging Trends and Challenges

• Regulatory Stringency: Increasing regulatory oversight may influence supplier eligibility, emphasizing quality compliance.
• Supply Chain Disruptions: Global disruptions, such as those caused by pandemics, underscore the importance of diversified supplier bases.
• Intellectual Property: As generic markets mature, some patent protections may fade, expanding supplier options but also raising quality concerns.
• Sustainability Initiatives: Suppliers adopting environmentally sustainable manufacturing processes are gaining favor.

Conclusion

The supply landscape for ketotifen fumarate is characterized by a mix of multinational pharmaceutical giants, regional API manufacturers, and emerging players in Asia. Leading suppliers like Novartis, Sandoz, Alchemy Laboratories, Zhejiang Hisun, and Jiangsu Hengrui possess robust manufacturing capabilities, regulatory compliance, and extensive distribution networks, making them reliable sources for global procurement. Strategic partnerships with certified suppliers that prioritize quality, compliance, and supply chain resilience are essential for maintaining a steady supply of ketotifen fumarate in an increasingly competitive and regulated environment.

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Key Takeaways

• Diverse Supplier Base: International giants and regional manufacturers provide a broad spectrum of options, balancing quality and cost.
• Regulatory Compliance is Critical: Ensuring suppliers hold GMP and relevant regulatory approvals minimizes risks related to product quality and market access.
• Supply Chain Resilience: Diversification and contingency planning mitigate risks from geopolitical, logistical, or pandemic-related disruptions.
• Cost-Quality Balance: Indian and Chinese manufacturers offer cost-effective APIs, but due diligence on quality standards is essential.
• Market Trends: Increased regulatory oversight and sustainability considerations are shaping supplier evaluation criteria.

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FAQs

1. Which countries dominate the manufacturing of ketotifen fumarate APIs?
India and China are the primary producers of ketotifen fumarate APIs, owing to their large-scale manufacturing facilities, cost advantages, and growing export capabilities.

2. What factors should pharmaceutical companies consider when selecting a ketotifen fumarate supplier?
Key factors include regulatory compliance (GMP, ISO certifications), quality consistency, supply chain reliability, price competitiveness, and the supplier's market reputation.

3. Are there any approved brands of ketotifen fumarate outside generics?
Yes. Novartis markets branded formulations of ketotifen fumarate, particularly in certain regions, ensuring standardized quality and efficacy.

4. How does regulatory approval influence supplier choice?
Regulatory approval from agencies like the FDA or EMA signifies adherence to international quality standards, reducing the risk of non-compliance and facilitating market entry in regulated environments.

5. What are the challenges faced by suppliers of ketotifen fumarate?
Challenges include maintaining consistent quality, meeting evolving regulatory standards, managing supply chain disruptions, and addressing environmental sustainability pressures.

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Sources:
[1] Pharmaceutical Market Research Reports, 2023.
[2] WHO Good Manufacturing Practice Guidelines, 2022.
[3] International Pharmaceutical Regulatory Updates, 2023.