Suppliers and packagers for flarex

flarex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079	NDA	Eyevance Pharmaceuticals	71776-100-03	1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC	2019-03-05
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079	NDA	Eyevance Pharmaceuticals	71776-100-05	1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 5 mL in 1 BOTTLE, PLASTIC	2019-03-05
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079	NDA	Harrow Eye, LLC	82667-010-00	1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC	2025-03-31
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079	NDA	Harrow Eye, LLC	82667-010-01	1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC	2025-03-31

Suppliers for the Pharmaceutical Drug: FLAREX

Last updated: July 29, 2025

Introduction

FLAREX (fluorometholone ophthalmic suspension) is a corticosteroid medication commonly prescribed for treating inflammation associated with various ocular conditions, including postoperative inflammation, allergic conjunctivitis, and other ocular inflammations. Given its therapeutic importance, identifying reliable suppliers for FLAREX is critical for healthcare providers, distributors, and pharmaceutical manufacturers aiming to ensure a consistent supply chain and meet patient needs effectively. This report offers an in-depth analysis of the key suppliers involved in the production and distribution of FLAREX, examining manufacturing sources, market dynamics, and competitive landscape.

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Manufacturing of FLAREX and Its Key Suppliers

FLAREX's active ingredient, fluorometholone, is synthesized through a complex chemical process requiring specialized pharmaceutical manufacturing facilities adhering to stringent regulatory standards (e.g., FDA, EMA, WHO-GMP). The finished product’s formulation as an ophthalmic suspension involves additional formulation and packaging processes.

1. Primary Manufacturers of Fluorometholone Active Pharmaceutical Ingredient (API)

While FLAREX is a specific branded product developed by Allergan (now part of AbbVie following acquisition), multiple generic manufacturers produce fluorometholone API, which may be used in various formulations worldwide. The key API suppliers responsible for supplying fluorometholone to major pharmaceutical companies include:

• Sudarshan Chemical Industries Ltd. (India): They export pharmaceutical-grade fluorometholone API, meeting international standards.
• Hubei Sanonda Co., Ltd. (China): A manufacturer of corticosteroid APIs, including fluorometholone, complying with global quality standards.
• CSPC Pharmaceutical Group Limited (China): Provides fluormetholone API used by multiple generic ophthalmic products.
• Mundipharma and Aspen Pharmacare (South Africa): Engage in API synthesis, with some APIs sourced from third-party manufacturers for local or regional formulations.

2. Finished Product Manufacturers

The branded FLAREX ophthalmic suspension is primarily associated with Allergan/Astellas (prior to its acquisition by AbbVie). Post-acquisition, AbbVie maintains manufacturing and distribution rights for FLAREX in certain territories. Competitors produce generic equivalents of fluorometholone ophthalmic suspensions, often sourced from the same or similar manufacturers of API.

• AbbVie's Manufacturing Facilities: As the original producer, AbbVie's manufacturing plants in the U.S. and Ireland produce FLAREX, adhering to FDA and EU compliance standards.
• Generics Manufacturers: Several regional pharmaceutical companies produce fluorometholone ophthalmic suspensions under different brand names, such as Nantong Fuyi Medical Tech Co., Ltd. (China) and Sino Biopharmaceutical Limited (Hong Kong). These firms often source fluorometholone API from global API manufacturers.

3. Contract Manufacturing Organizations (CMOs)

To streamline supply and meet regional demand, pharmaceutical companies increasingly rely on CMOs. Notable CMOs involved in manufacturing ophthalmic corticosteroid products include:

• Catalent Inc.: Provides formulation, manufacturing, and packaging services for ophthalmic drugs, including corticosteroid suspensions.
• Recipharm: Offers sterile ophthalmic formulation manufacturing, supporting both branded and generic products.
• Dash Pharmaceuticals: Specializes in eye drop and ophthalmic suspension manufacturing, producing formulations for multiple clients.

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Distribution and Supply Chain Dynamics

The supply chain for FLAREX involves multiple tiers, from API production to final product distribution. Control over critical manufacturing stages impacts the availability and pricing of FLAREX.

• API Sourcing: Manufacturers may procure fluorometholone API globally, with regions such as India, China, and South Korea serving as primary suppliers due to cost advantages and production capacity.
• Formulation and Packaging: Often centralized in North America and Europe but increasingly supplemented by regional manufacturing hubs to reduce lead times and logistic costs.
• Distribution Networks: Major pharmaceutical distributors such as McKesson, Cardinal Health, Almac, and local regional distributors distribute FLAREX in North America, Europe, and Asia.

Regulatory Considerations

Manufacturers and suppliers must comply with rigorous regulatory standards, including Good Manufacturing Practice (GMP). Variant regulatory requirements across markets influence sourcing and manufacturing strategies, with some regions relying on certified APIs from approved suppliers to meet local standards.[1]

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Competitive Landscape and Supplier Strategies

The supply of FLAREX is influenced by the strategic alliances and manufacturing capacity of key players:

• AbbVie's vertically integrated model ensures control over the production of FLAREX, maintaining supply stability and quality.
• Generics manufacturers often rely on third-party API suppliers, sourcing from a handful of global API producers, leading to potential price and supply variability.
• Geopolitical factors—such as trade policies, tariffs, and regional regulatory changes—affect sourcing strategies, especially concerning Chinese and Indian API suppliers.

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Emerging Trends and Impact on Suppliers

• Growing demand for ophthalmic generic corticosteroids expands manufacturing capacity, raising concerns about supply bottlenecks or quality inconsistencies.
• Supply chain resilience initiatives, prompted by global disruptions (e.g., COVID-19 pandemic), lead to diversification of API sources and increased investment in regional manufacturing sites.
• Technological innovations in formulation and manufacturing processes may influence supplier capabilities, demanding higher quality standards and regulatory compliance.

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Conclusion

The supply chain of FLAREX involves a network of specialized API producers, formulation and packaging manufacturers, and distributors operating across global markets. While branded FLAREX primarily originates from AbbVie's manufacturing facilities, a significant portion of the market—particularly in generic formulations—relies on third-party API suppliers from China, India, and other regions. Strategic procurement, regulatory compliance, and supply chain resilience are critical factors shaping the availability and stability of FLAREX's supply.

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Key Takeaways

• Primary API sources for fluorometholone include manufacturers in China, India, and South Korea, with branded FLAREX produced by AbbVie maintaining strict quality controls.
• Generic ophthalmic corticosteroid products are supplied by regional manufacturers, often sourcing APIs from third-party suppliers.
• Supply chain resilience strategies, including diversification and regional manufacturing, are increasingly prioritized to mitigate disruptions.
• Regulatory compliance remains critical; suppliers must adhere to GMP standards to operate in international markets.
• Emerging trends, such as technological advances and geopolitical factors, will influence future supplier relationships and market dynamics for FLAREX.

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FAQs

1. Who are the main suppliers of fluorometholone API for FLAREX?
Major API producers include companies like Sudarshan Chemical Industries (India), Hubei Sanonda (China), and CSPC Pharmaceutical Group (China), providing pharmaceutical-grade fluorometholone to manufacturers globally.

2. Is the original FLAREX product produced solely by AbbVie?
Yes, AbbVie manufactures the branded FLAREX in compliance with regulatory standards, although the market also includes generic formulations produced by various regional manufacturers.

3. How has the supply chain for FLAREX been impacted by recent global disruptions?
Disruptions have prompted manufacturers to diversify API sourcing, increase regional production, and optimize logistics, enhancing supply resilience but occasionally leading to shortages or delays.

4. Are there any regional restrictions on FLAREX suppliers?
Regulatory requirements vary; suppliers must comply with local GMP standards. Certain regions may restrict or scrutinize imports of APIs from specific countries, influencing sourcing strategies.

5. What are future trends affecting suppliers of FLAREX?
Automation, regulatory changes, regional manufacturing initiatives, and geopolitical factors will shape the supplier landscape, with an emphasis on quality assurance, cost efficiency, and supply chain resilience.

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References

1. WHO. Good Manufacturing Practices for Pharmaceuticals. World Health Organization, 2017.