Suppliers and packagers for generic pharmaceutical drug: FLUOROMETHOLONE

FLUOROMETHOLONE

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
Amneal	FLUOROMETHOLONE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	216348	ANDA	Amneal Pharmaceuticals NY LLC	60219-1585-3	1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER	2023-01-09
Amneal	FLUOROMETHOLONE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	216348	ANDA	Amneal Pharmaceuticals NY LLC	60219-1586-6	1 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER	2023-01-09

Comprehensive Analysis of Fluorometholone Suppliers in the Global Pharmaceutical Market

Fluorometholone, a synthetic glucocorticoid corticosteroid, is widely used in ophthalmic formulations to treat inflammatory conditions such as conjunctivitis, keratitis, and postoperative ocular inflammation. Its anti-inflammatory properties make it a critical therapeutic agent, driving demand across global markets. This report provides an exhaustive analysis of the fluorometholone supply chain, highlighting key manufacturers, regulatory landscapes, market dynamics, and emerging challenges.

---

Global Supplier Landscape of Fluorometholone

The fluorometholone market is characterized by a diverse network of active pharmaceutical ingredient (API) manufacturers, formulation developers, and distributors. Suppliers operate across continents, with significant concentrations in Asia, North America, and Europe.

Key API Manufacturers

Symbiotec Pharmalab (India)

Symbiotec Pharmalab specializes in corticosteroid APIs, including fluorometholone. The company holds certifications such as USDMF (U.S. Drug Master File) and CEP (Certification of Suitability to the European Pharmacopoeia), ensuring compliance with stringent international quality standards[2][7]. Symbiotec’s vertically integrated production facilities enable cost-effective scaling, making it a preferred supplier for generic drug manufacturers.

Gonane Pharma (India)

Gonane Pharma, another major Indian API producer, focuses on steroid hormones and corticosteroids. With WHO-GMP certification, the company supplies fluorometholone to regulated markets, including the U.S. and EU[2][9]. Its expertise in complex synthesis processes ensures high-purity APIs, critical for ophthalmic formulations.

Teva Pharmaceutical Industries (Israel)

Teva, a global generics leader, produces fluorometholone APIs and finished formulations. The company’s vertically integrated supply chain and 14 international manufacturing sites position it as a resilient supplier amid geopolitical and logistical disruptions[9].

ACS Dobfar (Italy)

ACS Dobfar, part of the multinational STADA group, manufactures fluorometholone acetate, a derivative used in sustained-release formulations. The company’s EU-WC (Written Confirmation) certification facilitates seamless exports to European markets[7].

Finished Product Suppliers

Allergan (U.S.)

Allergan, now part of AbbVie, historically dominated the branded fluorometholone market with products like FML® Liquifilm. However, the company discontinued its fluorometholone ointment in 2024, creating supply gaps[8]. Allergan’s suspension formulations remain available, but competitors like Amneal Pharmaceuticals have capitalized on this exit[3].

Amneal Pharmaceuticals (U.S.)

Amneal launched a generic fluorometholone ophthalmic suspension in 2024, securing 180-day competitive generic therapy (CGT) exclusivity. This strategic move strengthened its position in the U.S. market, particularly in serving hospital and retail pharmacy networks[3].

AdvaCare Pharma (China)

AdvaCare Pharma operates GMP-compliant facilities in China, producing fluorometholone eye drops for export to 65 countries. The company emphasizes affordability, pricing its products 20–30% below Western counterparts, making it a key supplier for low- and middle-income markets[4].

Cipla and Sun Pharma (India)

Indian pharmaceutical giants Cipla and Sun Pharma offer fluorometholone-tobramycin combination drops, addressing bacterial superinfections in inflammatory eye conditions. Their extensive distribution networks across Africa and Southeast Asia ensure widespread access[5][13].

---

Regulatory Environment and Compliance

Good Manufacturing Practices (GMP)

Fluorometholone manufacturers must adhere to GMP guidelines to ensure product safety and efficacy. For example, Symbiotec Pharmalab’s FDA-inspected facilities undergo biannual audits, while AdvaCare Pharma aligns with WHO-GMP standards to serve emerging markets[2][4].

Market-Specific Certifications

• USDMF: Required for U.S. market entry, this dossier details API manufacturing processes. Companies like Symbiotec and Gonane Pharma maintain active USDMFs[2][9].
• CEP: Issued by the European Directorate for the Quality of Medicines, CEP certification allows suppliers like ACS Dobfar to distribute APIs across the EU[7].
• KDMF: South Korea’s Drug Master File system mandates rigorous stability testing, a hurdle cleared by manufacturers such as Teva[9].

Impact of Regulatory Actions

The FDA’s 2024 warning letter against a Chinese API manufacturer for data integrity violations disrupted the fluorometholone supply chain, underscoring the importance of robust quality systems[9]. Conversely, the European Medicines Agency’s approval of biosimilar corticosteroids has intensified competition, pressuring suppliers to reduce prices[10].

---

Market Dynamics and Competitive Landscape

Market Size and Growth

The global fluorometholone eye drops market was valued at $290 million in 2023, projected to grow at a 4.8% CAGR through 2030. Key drivers include rising prevalence of allergic conjunctivitis and post-cataract surgery inflammation[10].

Regional Demand

• North America: Accounts for 38% of market share, driven by high healthcare spending and frequent corticosteroid prescriptions. Amneal’s 2024 launch exemplifies strategic market entry tactics[3][10].
• Asia-Pacific: Expected to grow at 6.2% CAGR, fueled by expanding generic drug industries in India and China. Suppliers like Niksan Pharmaceutical leverage low production costs to dominate regional markets[11][13].
• Europe: Stringent pricing reforms have shifted demand toward biosimilars, though fluorometholone retains niche use in chronic uveitis management[7][10].

Competitive Strategies

• Vertical Integration: Teva and Sun Pharma control API synthesis, formulation, and distribution, mitigating raw material shortages[9][13].
• First-to-Market Exclusivity: Amneal’s 180-day CGT exclusivity for its generic suspension allowed premium pricing before competitor entry[3].
• Portfolio Diversification: Companies like Cipla combine fluorometholone with antibiotics (e.g., tobramycin) to address comorbid infections, enhancing product differentiation[5].

---

Pricing and Supply Chain Considerations

Cost Structures

• API Pricing: Fluorometholone API prices range from $40–$60 per gram, influenced by purity grades (USP vs. EP) and order volumes. Indian manufacturers offer bulk discounts, reducing costs by 15–20% for orders exceeding 100 kg[6][9].
• Finished Products: A 5 mL bottle of fluorometholone ophthalmic suspension retails for $74–$139 in the U.S., while Indian generics like Flomex® cost under $15 locally[5][12].

Supply Chain Risks

• Geopolitical Instability: The 2024 Red Sea shipping disruptions delayed API shipments from India to Europe, increasing lead times by 3–4 weeks[13].
• Regulatory Delays: In 2024, the FDA’s increased scrutiny of Indian manufacturing sites caused temporary API shortages, boosting prices by 12%[9][11].

Procurement Strategies

Hospitals and pharmacies increasingly use consortium purchasing to negotiate volume discounts. For example, a 2024 Group Purchasing Organization (GPO) contract in the U.S. secured a 22% price reduction for fluorometholone suspensions[12].

---

Challenges and Future Outlook

Patent Expiries and Generic Competition

Allergan’s FML® Liquifilm patent expiry in 2022 opened the door for generics, eroding branded sales by 34% annually. However, complex formulation patents for combination products (e.g., fluorometholone + NSAIDs) remain in force until 2030, limiting competition[3][10].

Supply Chain Localization

Post-pandemic, governments prioritize API self-sufficiency. India’s Production-Linked Incentive (PLI) scheme subsidizes fluorometholone API production, aiming to cut import reliance from 60% to 30% by 2030[11]. Similarly, the U.S. Defense Production Act allocates $50 million to domestic corticosteroid manufacturing[8].

Sustainable Manufacturing

Environmental regulations are reshaping production practices. Symbiotec Pharmalab’s zero-liquid discharge facility, operational since 2023, reduces water usage by 40%, setting a benchmark for eco-friendly API synthesis[2].

---

Fluorometholone’s critical role in ophthalmic care ensures sustained demand, but suppliers must navigate regulatory complexities, geopolitical risks, and pricing pressures. Strategic partnerships, vertical integration, and investment in sustainable technologies will define market leadership in the coming decade.

References

1. https://www.keelerusa.com/fluorometholone-drops-0-1-5ml.html
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/fluorometholone
3. https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Launches-Complex-Generic-Fluorometholone-Ophthalmic-Suspension/default.aspx
4. https://www.advacarepharma.com/en/pharmaceuticals/fluorometholone-eye-drops
5. https://dir.indiamart.com/impcat/fluorometholone-eye-drop.html
6. https://www.targetmol.com/compound/fluorometholone
7. https://www.pharmacompass.com/manufacturers-suppliers-exporters/fluorometholone-acetate
8. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=613
9. https://pharmaoffer.com/api-excipient-supplier/corticosteroids/fluorometholone
10. https://reports.valuates.com/market-reports/QYRE-Auto-11K14892/global-fluorometholone-eye-drops
11. https://www.niksanpharmaceutical.co.in/fluorometholone-5767281.html
12. https://www.drugs.com/price-guide/fluorometholone-ophthalmic
13. https://www.exportersindia.com/indian-suppliers/fluorometholone.htm