XALATAN: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597	NDA	Viatris Specialty LLC	58151-419-35	1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER	2024-10-22
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0333-2	1 BOTTLE, DROPPER in 1 CARTON (59762-0333-2) / 2.5 mL in 1 BOTTLE, DROPPER	2010-11-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Xalatan, a trade name for the drug latanoprost, is a widely prescribed medication used primarily for the reduction of intraocular pressure in patients with open-angle glaucoma and ocular hypertension. As a prostaglandin analog, Xalatan has established itself as an essential ophthalmic treatment globally. Its widespread utilization necessitates an understanding of its suppliers, which include both original equipment manufacturers (OEMs) and generic manufacturers. The integrity of the supply chain directly influences drug availability, price stability, and regulatory oversight. This article provides a comprehensive analysis of the current suppliers of Xalatan, examining their manufacturing footprints, regulatory certifications, and market implications.

Overview of XALATAN Supply Chain

The supply chain for Xalatan encompasses raw material producers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, packaging entities, and distributors. The API, latanoprost, is synthesized through complex chemical processes, often requiring specialized chemical intermediates and regulated manufacturing environments. Once produced, the API is compounded into ophthalmic solutions by licensed pharmaceutical manufacturers before reaching pharmacies and hospitals.

The original patent holder, Pfizer Inc., historically dominated the production and distribution of Xalatan. However, patent expirations in numerous jurisdictions have led to an influx of generic manufacturers, expanding global supply sources.

Original Manufacturers and Suppliers of XALATAN

Pfizer Inc.

Pfizer, the original patent holder, has historically been the primary supplier of Xalatan. The company oversees the production of the branded product, ensuring compliance with pharmacopoeia standards and regulatory requirements globally. Pfizer operates facilities certified by health authorities such as the FDA (US Food and Drug Administration), EMA (European Medicines Agency), and other national agencies, maintaining high-quality control over their manufacturing processes.

Regulatory and Quality Standards

Pfizer's manufacturing sites for Xalatan are typically certified under the cGMP (current Good Manufacturing Practice) guidelines, confirming adherence to stringent quality parameters necessary for ophthalmic drugs. As the originator, Pfizer's supply is characterized by consistency and rigorous batch validation.

Generic Manufacturers and Suppliers

Following patent expiry in many regions, numerous generic pharmaceutical companies entered the Xalatan market, diversifying the supply sources. The proliferation of generics has increased competition, leading to cost reductions but also raising considerations over quality assurance.

Key Generic Suppliers

Sun Pharmaceutical Industries Ltd.

Based in India, Sun Pharma has established itself as a leading generic manufacturer of ophthalmic products, including latanoprost. The company's facilities are inspected by regulatory authorities worldwide, and its products often hold approvals from Indian (DCGI), US (FDA), European, and other agencies.
Molecule Pharmaceuticals

Operating primarily in Latin America, Molecule Pharmaceuticals supplies generic latanoprost formulations, often sourced through local regulatory approvals and partnerships.
Sandoz (Novartis)

As a division of Novartis, Sandoz produces ophthalmic generics, including latanoprost, with manufacturing plants certified under international standards.
U.S. and European Regulatory-Approved Generics

Several other companies, such as Allergan (now part of AbbVie), Teva Pharmaceuticals, and Amneal Pharmaceuticals, manufacture approved generic latanoprost. These entities adhere to quality standards dictated by respective regulatory bodies, ensuring efficacy and safety.

Manufacturing Locations

Generic API production typically occurs in India, China, and Europe. These regions host API facilities with certifications from US FDA, EMA, and other authorities, ensuring compliance with global quality benchmarks.

API Suppliers for Latanoprost

The quality of the API is pivotal for the safety and efficacy of Xalatan. Leading API manufacturers include:

WuXi AppTec (China)
Shaanxi Top Pharmaceutical (China)
Sachem Inc. (USA)
LUPIN Limited (India)
Dr. Reddy's Laboratories (India)

These suppliers provide bulk latanoprost API to pharmaceutical companies manufacturing both the branded and generic formulations.

Supply Considerations

The API production process involves complex organic synthesis, typically starting from chlorinated intermediates and involving multiple reaction steps. Keeping the supply chain resilient involves diversified sourcing, quality assurance, and compliance monitoring.

Regulatory Certification and Quality Assurance

Suppliers of Xalatan and latanoprost API are subject to rigorous inspections and certifications, including:

FDA inspections for US-market approved APIs and finished formulations.
EMA certification for European market approval.
WHO prequalification programs, which facilitate procurement by WHO for developing countries.
ISO certifications (primarily ISO 9001) for manufacturing quality management systems.

Due to the critical nature of ophthalmic drugs, manufacturers often participate in external audits, stability testing, and batch validation to maintain licensing.

Market Dynamics and Supply Chain Challenges

The supply landscape has experienced shifts driven by patent expirations, geopolitical factors, and regulatory changes. Notable challenges include:

Supply disruptions due to manufacturing delays, regulatory compliance issues, or geopolitical tensions, notably in regions like China and India.
Pricing pressures resulting from increased generic competition.
Quality assurance concerns stemming from variable manufacturing standards among third-party API suppliers.
Regulatory compliance that may limit entry or cause market withdrawals if standards are not maintained.

Developers and distributors mitigate these risks through diversified supplier networks, strategic stockpiling, and strict quality audits.

Conclusion

The supply of Xalatan is now characterized by a complex global ecosystem comprising original manufacturers like Pfizer and a broad spectrum of generic producers. API supply chains are distributed across Asia, Europe, and North America, emphasizing the importance of regulatory compliance and quality management. Ensuring the stability of this supply chain requires ongoing diligence, particularly amidst geopolitical shifts and evolving regulatory standards.

Key Takeaways

The original producer of Xalatan, Pfizer, maintains high-quality manufacturing standards but faces increased competition from multiple generic manufacturers following patent expiry.
The global API supply chain for latanoprost involves suppliers in China, India, and Europe, with certifications from major health authorities vital for market access.
Quality assurance and regulatory compliance are critical for maintaining drug safety and efficacy; suppliers with stringent certifications are favored.
Supply chain risks, including geopolitical tensions and regulatory non-compliance, necessitate diversified sourcing and robust quality management systems.
Market dynamics favor reduced prices due to increased generic competition, but quality consistency across suppliers remains a pivotal concern.

FAQs

Who are the main suppliers of latanoprost API used in Xalatan?
Major API suppliers include WuXi AppTec (China), Shaanxi Top Pharmaceutical (China), Lupin Limited (India), and Dr. Reddy’s Laboratories (India). These companies provide bulk latanoprost API to various pharmaceutical manufacturers globally.
How does patent expiration affect the supply chain of Xalatan?
Patent expiration enables generic manufacturers to produce biosimilar versions, increasing supply diversity and competition. This shift often lowers prices and expands geographic availability, but raises concerns around quality assurance and regulatory compliance among new entrants.
What quality standards govern the manufacturing of Xalatan and its ingredients?
Manufacturers must adhere to cGMP guidelines, hold certifications from regulatory agencies such as the FDA or EMA, and participate in programs like WHO prequalification to ensure product safety, efficacy, and quality.
Are there supply risks associated with Xalatan?
Yes. Risks include manufacturing disruptions, geopolitical issues, regulatory delays, and quality failures. Supply chain diversification and rigorous quality controls are strategies to mitigate these risks.
What role do regulatory agencies play in ensuring supplier quality?
Agencies such as the FDA and EMA conduct inspections, approve manufacturing facilities, and monitor ongoing compliance. They set standards that suppliers must meet, facilitating the safe and effective distribution of Xalatan globally.

Sources:

Pfizer Inc. official website
U.S. Food & Drug Administration (FDA) database on approved ophthalmic drugs
World Health Organization (WHO) prequalification programs
Indian regulatory authority (DCGI) approvals and certifications
Industry reports on generic ophthalmic medications

Suppliers and packagers for XALATAN

XALATAN

Suppliers for the Pharmaceutical Drug: XALATAN