Suppliers and packagers for fml

fml

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA	Allergan, Inc.	11980-211-05	1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER	1972-02-01
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA	Allergan, Inc.	11980-211-10	1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER	1972-02-01
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-880-05	1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER	1997-10-31
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-880-10	1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER	1997-10-31

Suppliers for the Pharmaceutical Drug: FML (Fluorometholone)

Last updated: August 4, 2025

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Introduction

FML (fluorometholone) is a corticosteroid widely used in ophthalmology for treating inflammation and allergic conditions of the eye. Its efficacy hinges on precise formulation and consistent manufacturing standards, making the availability of reliable suppliers crucial for healthcare providers and pharmaceutical companies. This article provides a comprehensive analysis of the key suppliers of fluorometholone, exploring manufacturing sources, global distribution channels, and the regulatory landscape shaping supply chains.

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Overview of FML (Fluorometholone)

Fluorometholone is an anti-inflammatory steroid typically formulated as eye drops. It suppresses inflammation by inhibiting multiple pathways in the immune response. Approved for use in several countries, its production involves complex chemical synthesis and stringent quality controls to meet pharmacopeial standards (USP, BP, EP) [1].

Given its prescription status and importance in ophthalmic therapy, reliable sourcing from authorized manufacturers is critical for healthcare safety and efficacy.

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Major Suppliers and Manufacturers

1. Mfg. Companies with Global Presence

Several pharmaceutical companies manufacture and supply fluorometholone either as a branded product or generic equivalent:

• Alcon Laboratories Inc.
  Alcon is a leading ophthalmic manufacturer, offering fluorometholone-based formulations under various brand names globally. Their products are manufactured in major facilities across North America, Europe, and Asia, adhering to the highest quality standards [2].

• Santen Pharmaceutical Co., Ltd.
  A Japanese ophthalmic specialist, Santen supplies fluorometholone formulations across Asia and has expanded into international markets, including the US and Europe. Santen's manufacturing facilities are compliant with Good Manufacturing Practices (GMP) and regulatory approvals [3].

• Bausch + Lomb (Part of Bausch Health Companies Inc.)
  Bausch + Lomb offers fluorometholone-based products as part of their ophthalmic portfolio. They operate manufacturing units across North America and Europe, with distribution networks covering global markets [4].

• Himant Stemcell and Pharmaceutical Pvt Ltd.
  An Indian pharmaceutical company, Himant, supplies generic formulations of fluorometholone primarily within the Indian subcontinent, which serves as a pivotal hub for generic ophthalmic solutions.

• Aurobindo Pharma
  Another key player from India, Aurobindo produces generic corticosteroid eye drops, including fluorometholone, exported worldwide, especially to regions with cost-sensitive healthcare systems [5].

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2. Contract Manufacturing and API Suppliers

The active pharmaceutical ingredient (API) for fluorometholone is sourced from specialized chemical manufacturers:

• Tapi Chemical Co., Ltd. (South Korea)
  Supplies high-purity fluorometholone API to global pharmaceutical companies.

• SAFC (Sciences Applied to Fine Chemicals)
  A subsidiary of Merck, SAFC offers reliable API synthesis and custom manufacturing, including fluorometholone.

• Yuhan Corporation (South Korea)
  Known for synthesizing corticosteroid APIs, Yuhan's APIs are used by several generics manufacturers.

• Dr. Reddy’s Laboratories
  Engages in API production and supplies to various finished drug manufacturers globally.

These suppliers primarily serve pharmaceutical companies that incorporate the API into their own formulations.

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Distribution Hubs and Regions

The geographic distribution of fluorometholone is concentrated across:

• North America: Driven by regulatory approval, patent pathways (in cases of branded formulations), and large-scale manufacturing controlled by companies like Alcon and Bausch + Lomb.

• Europe: Several GMP-compliant suppliers cater to markets in the EU, with regulatory agencies like EMA overseeing quality standards.

• Asia-Pacific: India, Japan, and South Korea are prominent sources of both generics and API manufacturing, supplying low-cost options to emerging markets.

• Emerging Markets: Local manufacturers in Latin America, Africa, and Southeast Asia distribute lower-cost formulations, often leveraging APIs from South Korean and Indian producers.

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Regulatory and Quality Considerations

• Regulatory Approvals: Suppliers must comply with local and international regulations (FDA, EMA, PMDA, etc.) to ensure market access. Suppliers with approved manufacturing sites are preferred for safety and efficacy.

• Quality Standards: Good Manufacturing Practices (GMP) certification is essential. Certificates of analysis (COA), stability data, and batch consistency are critical for sourcing decisions.

• Patent Landscape: While generic formulations are widespread, patent status may influence the choice of suppliers, especially within markets where patent protections are still enforced.

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Market Dynamics and Supply Chain Challenges

• API Shortages: Global disruptions, such as the COVID-19 pandemic, have led to shortages in corticosteroid APIs, including fluorometholone, impacting supply chains.

• Price Fluctuations: Variability in raw material costs, especially in India and South Korea, affect the overall price of finished products.

• Regulatory Barriers: Stringent approval processes and quality audits may delay market entry or restrict supplier options.

• Counterfeit Risks: The ophthalmic use of corticosteroids necessitates sourcing from reputable suppliers to avoid counterfeit products, which could jeopardize patient safety.

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Conclusion

The supply landscape for fluorometholone encompasses a broad spectrum of global manufacturing entities, primarily from North America, Europe, and Asia. Leading ophthalmic pharmaceutical companies like Alcon, Santen, and Bausch + Lomb dominate the branded markets, while Indian generics manufacturers provide cost-effective alternatives. The API supply chain mainly involves Asian chemical producers, ensuring a steady supply niche for finished formulation manufacturers.

Ensuring supply chain integrity involves diligent oversight of regulatory compliance, quality assurance, and geopolitical stability. As demand persists in ophthalmology, strategic procurement planning and diversification of supplier sources remain critical for healthcare providers and pharmaceutical companies.

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Key Takeaways

• Major global suppliers include Alcon, Santen, Bausch + Lomb, and Indian generics producers such as Aurobindo and Himant.

• API sources are predominantly from South Korea and India, with strict GMP compliance necessary for quality assurance.

• Regional distribution is strongest across North America, Europe, and Asia-Pacific, with emerging markets increasingly reliant on cost-effective generics.

• Supply chain risks include API shortages, regulatory hurdles, and counterfeit products; mitigation strategies involve supplier audits and diversified sourcing.

• Regulatory compliance (FDA, EMA, PMDA) remains non-negotiable for market approval and product safety.

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FAQs

1. Who are the leading manufacturers of fluorometholone ophthalmic products globally?
Leading manufacturers include Alcon, Bausch + Lomb, and Santen, all of which produce branded fluorometholone formulations meeting international quality standards.

2. What are the typical sources of API for fluorometholone?
Primary API sources are South Korean companies like Yuhan and Tapi Chemical, alongside Indian manufacturers such as Dr. Reddy’s Laboratories and Aurobindo.

3. How does the regulatory environment influence supplier choice?
Suppliers must hold GMP certifications and have products approved by regulatory agencies (FDA, EMA). Approval statuses dictate market access and influence procurement decisions.

4. Are there regional differences in fluorometholone supply chains?
Yes. North America and Europe rely on brand-name suppliers with advanced manufacturing standards; Asia, especially India and South Korea, predominantly supplies generics and APIs for broader markets.

5. What risks threaten the stability of fluorometholone supply?
Global API shortages, geopolitical instability, regulatory delays, and counterfeit product risks can all disrupt supply chains. Diversification and supplier audits are essential mitigation strategies.

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References

1. United States Pharmacopeia (USP). "Fluorometholone Monograph." USP.org, 2022.
2. Alcon Laboratories Inc. Product Portfolio and Quality Certifications. Alcon.com, 2023.
3. Santen Pharmaceutical Co., Ltd. Official Website. Santen.com, 2023.
4. Bausch + Lomb. Corporate Overview and Product Data. BauschLomb.com, 2023.
5. Aurobindo Pharma. API & Formulation Data. Aurobindo.com, 2023.