Last updated: July 29, 2025
Introduction
Bromfenac sodium is a non-steroidal anti-inflammatory drug (NSAID) primarily used in ophthalmology to reduce postoperative inflammation and pain following ocular surgery, such as cataract extraction. Its efficacy in inhibiting cyclooxygenase enzymes makes it a critical component in ocular therapeutic regimens. As demand for ophthalmic NSAIDs continues to grow, sourcing reliable suppliers for bromfenac sodium becomes essential for pharmaceutical companies, distributors, and healthcare providers. This comprehensive analysis highlights key suppliers, factors influencing sourcing decisions, and market dynamics surrounding bromfenac sodium.
Overview of Bromfenac Sodium
Bromfenac sodium is characterized by its potent anti-inflammatory properties with enhanced tissue penetration, especially in ocular tissues. Pharmaceutical-grade bromfenac sodium is available in various formulations, including ophthalmic solutions, and its active pharmaceutical ingredient (API) is produced through complex chemical synthesis processes.
Major Suppliers of Bromfenac Sodium
1. Major API Manufacturers
Bromfenac sodium is typically produced as a bulk API by several established chemical manufacturers. These companies often serve as primary suppliers to pharmaceutical finished drug manufacturers.
a) Privately-Owned Chemical Companies
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Tapioca Chemicals
Based in India, Tapioca Chemicals is recognized for manufacturing high-quality ophthalmic APIs, including bromfenac sodium, and exporting globally (reference: PharmTech India).
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Yantai Giltech Co., Ltd.
A Chinese manufacturer with capabilities in producing NSAID APIs, including bromfenac sodium, with compliance to international standards such as cGMP and ISO certifications.
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Shaanxi Top Pharm Chemical Co., Ltd.
Specializes in research, development, and manufacturing of pharmaceutical intermediates and APIs, including bromfenac sodium, with regulatory approvals for export.
b) Multinational Pharmaceutical Ingredient Suppliers
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Siegfried AG (Switzerland)
Known for custom synthesis, Siegfried supplies ophthalmic APIs including bromfenac sodium to pharmaceutical firms globally.
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Jubilant Life Sciences Ltd. (India)
Offers a portfolio of NSAID APIs, including bromfenac sodium, aligning with stringent quality and regulatory standards.
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Huntsman (USA/Europe)
Provides specialized chemical intermediates used in API synthesis, indirectly supporting bromfenac sodium production.
2. Finished Dosage Form Manufacturers
While API suppliers are crucial, several pharmaceutical companies manufacture and distribute bromfenac sodium ophthalmic solutions directly:
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Bausch + Lomb
The American multinational is among the leading manufacturers of bromfenac-based ophthalmic solutions, such as Xibrom and Bromsite.
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Alcon
A major player in ophthalmology, producing bromfenac ophthalmic formulations under various brand names.
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Senju Pharmaceutical Co., Ltd.
A Japanese firm with extensive ophthalmic product lines, including bromfenac eye drops.
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Ichimaru Pharcos (Japan)
Supplies preservatives-free ophthalmic solutions utilizing bromfenac sodium, primarily in Asian markets.
Factors Influencing Supplier Selection
Regulatory Compliance and Certification
Suppliers must meet international standards such as cGMP, ISO 9001, and DEA regulations where applicable. Particularly for APIs intended for ophthalmic use, strict quality controls are mandatory to ensure safety and efficacy.
Quality and Purity Standards
Suppliers should provide detailed Certificates of Analysis (CoA) confirming high purity (>99%), low residual solvents, and absence of impurities such as related compounds or residual reagents.
Supply Chain Reliability
Consistent delivery schedules, scalability for bulk orders, and contingency plans are vital amidst global supply chain disruptions.
Cost and Pricing Transparency
Competitive pricing, coupled with transparency regarding manufacturing costs and potential trade-offs with quality, influences sourcing decisions.
Regulatory Approvals and Market Access
Suppliers with proven regulatory track records, including FDA approval for their manufacturing facilities, facilitate faster market entry and reduce compliance risks.
Market Dynamics and Trends
Growing Demand for Ophthalmic NSAIDs
The aging global population and increasing prevalence of cataracts and postoperative ocular inflammation drive demand for bromfenac sodium. This, in turn, augments procurement volume and supplier competition.
Generic Market Expansion
Based on patent expirations in certain markets, generic manufacturers increasingly manufacture bromfenac sodium formulations, intensifying competition among suppliers.
Regional Supply Variability
Asia-Pacific dominates as the primary source of bromfenac sodium APIs due to cost efficiencies and manufacturing capacity. However, Western regulatory standards influence the entry of suppliers into markets like the United States and Europe.
Regulatory Harmonization
Global harmonization efforts and increased regulatory scrutiny may favor suppliers adhering to high compliance standards, impacting supplier choice.
Key Challenges in Sourcing Bromfenac Sodium
- Quality Assurance: Ensuring API batches meet pharmacopoeial standards (e.g., USP, EP).
- Supply Chain Constraints: Disruptions due to geopolitical issues, COVID-19 pandemic, or logistics problems.
- Price Fluctuations: Volatility in raw material costs can impact API pricing.
- Regulatory Barriers: Evolving approval requirements may restrict certain suppliers’ access to specific markets.
Conclusion
Reliable sourcing of bromfenac sodium necessitates a strategic approach encompassing thorough evaluation of supplier quality, compliance, capacity, and market reputation. Asia-Pacific remains a focal region for API manufacturing, with India and China being dominant players. Western companies emphasize stringent quality controls and regulatory compliance to meet stringent market standards. Established ophthalmic formulation manufacturers often develop their APIs or partner with certified suppliers to ensure product integrity and regulatory adherence.
Key Takeaways
- Global API landscape for bromfenac sodium is dominated by India and China, with niche offerings from European and Japanese producers.
- Quality assurance and regulatory compliance are paramount; suppliers with ISO, cGMP, and EUGMP certifications are preferred.
- Supply chain resilience requires diversified supplier bases and robust logistics planning to mitigate disruptions.
- Growing demand for ophthalmic NSAIDs boosts market opportunities, yet intensifies competition among suppliers.
- Informed procurement involves evaluating supplier track records, purity standards, and regulatory endorsements to ensure product safety and efficacy.
FAQs
Q1: What are the primary regions supplying bromfenac sodium APIs?
A: India and China are the primary regions manufacturing bromfenac sodium APIs, supported by numerous certified producers catering to global markets.
Q2: How can I verify the quality of bromfenac sodium supplied by a new manufacturer?
A: Request Certificates of Analysis (CoA), review compliance with pharmacopoeial standards, verify certifications such as cGMP, ISO, and conduct independent testing if necessary.
Q3: Are there any regulatory considerations when sourcing bromfenac sodium?
A: Yes. Suppliers should comply with the regulations of the target market, such as FDA in the U.S., EMA in Europe, or PMDA in Japan. Regulatory approvals and quality certifications are crucial.
Q4: Can I source bromfenac sodium from multiple suppliers?
A: Diversifying sources mitigates supply risk but requires rigorous quality controls to ensure batch consistency and regulatory compliance.
Q5: What are the typical costs associated with bromfenac sodium APIs?
A: Costs vary depending on purity, quantity, supplier, and market conditions; generally, bulk API prices range from $200 to $400 per kilogram, but specifications and certifications can influence pricing.
References
- [1] PharmTech India, "Ophthalmic API Manufacturing in India," 2022.
- [2] Siegfried AG, Product portfolio and quality standards.
- [3] Japanese Ophthalmic Market Reports, 2021.
- [4] Global Pharmaceutical Industry Analysis, 2023, MarketWatch.
- [5] Regulatory Requirements for Ophthalmic APIs, US FDA and EMA guidelines, 2022.
