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Suppliers and packagers for FML FORTE
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FML FORTE
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 FORTE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 019216 | NDA | Allergan, Inc. | 11980-228-05 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER | 1986-05-01 |
| Abbvie | FML FORTE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 019216 | NDA | Allergan, Inc. | 11980-228-10 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER | 1986-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FML FORTE
Introduction
FML FORTE is a corticosteroid ophthalmic medication primarily used to reduce inflammation and allergic reactions in the eyes. The active ingredient in FML FORTE is fluorometholone, a synthetic corticosteroid with anti-inflammatory properties. The drug is formulated for topical ophthalmic use, often prescribed post-surgery or for allergic conjunctivitis.
The manufacturing and supply chain for FML FORTE involve several key components, including raw material sourcing, formulation, quality control, packaging, and distribution. Given its medical importance, particularly in ophthalmology, reliable sourcing of active pharmaceutical ingredients (APIs) and finished products is critical for healthcare providers and distributors. This article explores the leading suppliers involved in the production of FML FORTE, their geographic distribution, and industry dynamics to inform stakeholders in pharmaceutical procurement and supply chain management.
Active Pharmaceutical Ingredient (API) Supply
Fluorometholone API Suppliers
The core component of FML FORTE is fluorometholone, a synthetic corticosteroid with the chemical formula C₂₆H₃₃FO₅. Its synthesis is complex, requiring advanced chemical expertise and strict quality controls. Several established chemical manufacturers supply fluorometholone API globally:
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Hetero Labs Limited (India): A major player in the biosimilars and active pharmaceutical ingredients market, Hetero is known for its robust portfolio of ophthalmic APIs, including fluorometholone. Their facilities adhere to cGMP standards, and the company exports to major pharmaceutical companies worldwide [1].
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Catalent (USA): As a leading provider of contract development and manufacturing organization (CDMO) services, Catalent supplies high-quality APIs, including ophthalmic corticosteroids. Although primarily known for finished dosage forms, they also provide APIs for strategic partners [2].
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Jiangsu Nhwa Pharmaceutical Co., Ltd. (China): A prominent Chinese manufacturer specializing in ophthalmic APIs, Jiangsu Nhwa produces fluorometholone for domestic and international markets, meeting stringent regulatory standards [3].
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Piramal Enterprises (India): With a significant API manufacturing footprint, Piramal manufactures corticosteroid APIs, including fluorometholone, and supplies to both generic and branded pharmaceutical firms [4].
Supply Chain Considerations
The sourcing of fluorometholone APIs depends on regulatory approvals, manufacturing capacity, and quality compliance. India and China dominate API production for corticosteroids, including fluorometholone, due to cost-effectiveness and scale. US and European firms often source APIs from these suppliers, prioritizing quality and regulatory compliance, especially for markets like the US, Europe, and Japan.
Finished Dosage Formulators and Distributors
Pharmaceutical Companies Manufacturing FML FORTE
FML FORTE is produced under various brand names globally, often by local manufacturers or authorized generic manufacturers. Notable companies include:
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Alcon (Switzerland): A global leader in ophthalmic products, Alcon produces and distributes fluorometholone-based eye drops, including formulations similar to or identical with FML FORTE, directly or via licensing agreements [5].
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Akorn (USA): A prominent manufacturer specializing in ophthalmic products, Akorn supplies fluorometholone eye drops often as generics or equivalent formulations under various brand names [6].
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Sun Pharmaceutical Industries Ltd. (India): As one of the world's largest generic pharmaceutical companies, Sun Pharma produces ophthalmic corticosteroids, including fluorometholone formulations, for domestic and export markets [7].
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Bausch + Lomb (USA): While primarily known for contact lenses and other ophthalmic products, Bausch + Lomb also develops corticosteroid eye drops, sometimes through licensing or partnerships [8].
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Local Manufacturers and Private Labelers: In addition to large corporations, numerous regional and private label ophthalmic pharmaceutical companies supply FML FORTE or equivalent formulations, especially in emerging markets such as Southeast Asia and Africa.
Distribution Channels
Distribution involves a complex supply chain with regional distributors, hospital pharmacies, and retail outlets. Governments and private healthcare chains rely on these suppliers to ensure consistent availability, regulatory compliance, and product quality.
Regulatory and Quality Standards
Suppliers of FML FORTE and its components face strict regulatory scrutiny. Manufacturers must comply with Good Manufacturing Practices (GMP) established by agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Indian Directorate General of Health Services (DGHS).
Global pharmaceutical companies and many regional suppliers also seek approvals from national regulatory authorities. For example:
- FDA approval or registration for US distribution.
- EMA approval for European markets.
- Central or local drug registration in countries in Asia, Africa, and Latin America.
These approvals influence supplier selection, as buyers prioritize manufacturers with proven regulatory track records.
Industry Dynamics and Trends
Geographic Concentration and Cost Factors
India and China dominate the production of corticosteroid APIs and generic ophthalmic drugs like FML FORTE because of lower manufacturing costs, established API infrastructure, and export-oriented policies. However, quality and regulatory compliance remain critical factors for international markets.
Impact of Patent Expirations and Generics
With patent protection lapsing for many corticosteroids, the market has shifted towards generics. Many suppliers now produce FML FORTE or equivalent formulations, increasing competition and driving prices down. This dynamic encourages collaborations and licensing agreements among multinational firms.
Supply Chain Risks
Recent global events, including the COVID-19 pandemic and geopolitical tensions, have exposed vulnerabilities in the API and finished drug supply chains. Dependence on Chinese and Indian suppliers underscores the importance of diversification and quality assurance to mitigate shortages.
Conclusion
The supply of FML FORTE hinges on a well-organized, compliant ecosystem comprising API manufacturers in India, China, and other Asian countries, and finished pharmaceutical producers across North America, Europe, and emerging markets. Key API suppliers include Hetero Labs, Jiangsu Nhwa Pharmaceutical, and Piramal Enterprises, with finished formulations manufactured by Alcon, Akorn, and Sun Pharma among others.
To sustain reliable supply chains, stakeholders must prioritize partnerships with GMP-compliant, regulatory-approved suppliers, monitor geopolitical and market shifts, and ensure quality standards to meet global demand for ophthalmic corticosteroids.
Key Takeaways
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API sourcing is predominantly from India and China, with top suppliers like Hetero Labs and Jiangsu Nhwa, emphasizing the need for due diligence and regulatory compliance.
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Major finished product manufacturers include Alcon, Akorn, and Sun Pharma, which supply formulations under various brand names globally.
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Regulatory adherence is critical; suppliers must comply with GMP and gain approvals for specific markets, influencing sourcing decisions.
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Supply chain resilience requires diversification, especially given geopolitical and pandemic-related disruptions impacting API availability.
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Market dynamics favor increased generic competition, which can reduce prices but heighten the importance of quality assurance and regulatory vigilance.
FAQs
1. What are the primary countries supplying fluorometholone API for FML FORTE?
India and China dominate API production due to manufacturing scale, cost advantages, and established expertise. Major API suppliers include Hetero Labs (India) and Jiangsu Nhwa (China).
2. How do regulatory standards influence supplier selection for FML FORTE?
Suppliers must meet GMP standards and obtain approvals from relevant authorities (FDA, EMA, local regulators). Regulatory confidence ensures safety, efficacy, and market access.
3. Are there risks associated with sourcing APIs from emerging markets?
Yes. Risks include regulatory variability, quality control issues, and geopolitical tensions. Due diligence, audits, and quality assurance protocols are vital.
4. How has the COVID-19 pandemic affected the supply chain for ophthalmic corticosteroids like FML FORTE?
The pandemic exposed vulnerabilities in supply chains, causing shortages due to disrupted manufacturing and transportation, particularly in API sourcing from China and India.
5. Can regional manufacturers produce equivalent formulations of FML FORTE?
Yes. Many local manufacturers produce fluorometholone eye drops, often as generics or licensed products, providing alternatives depending on regional regulations and demand.
References
[1] Hetero Labs Limited. (2022). API Portfolio. Retrieved from hetero.co.in
[2] Catalent Inc. (2022). About Us. Retrieved from catalent.com
[3] Jiangsu Nhwa Pharmaceutical. (2022). Product Portfolio. Retrieved from nhwapharm.com.cn
[4] Piramal Enterprises. (2022). API Manufacturing. Retrieved from piramal.com
[5] Alcon. (2022). Ophthalmic Products. Retrieved from alcon.com
[6] Akorn. (2022). Ophthalmology Portfolio. Retrieved from akorn.com
[7] Sun Pharmaceutical Industries Ltd. (2022). Product List. Retrieved from sunpharma.com
[8] Bausch + Lomb. (2022). Ophthalmic Solutions. Retrieved from bausch.com
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