Suppliers and packagers for bromsite

bromsite

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	BROMSITE	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206911	NDA	Sun Pharmaceutical Industries, Inc.	49708-754-41	1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER	2016-05-01
Sun Pharm	BROMSITE	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206911	NDA AUTHORIZED GENERIC	Sun Pharmaceutical Industries, Inc.	49708-755-41	1 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER	2024-02-07

Suppliers for the Pharmaceutical Drug: BROMSITE

Last updated: August 1, 2025

Introduction
Bromsite, known generically as bromfenac ophthalmic solution, is a non-steroidal anti-inflammatory drug (NSAID) widely used to reduce inflammation and pain following ocular surgery, notably cataract procedures. Its unique therapeutic profile necessitates a dependable supply chain, involving multiple manufacturers and authorized suppliers to ensure quality, consistency, and regulatory compliance. Understanding the global landscape of Bromsite suppliers is crucial for stakeholders ranging from healthcare providers to pharmaceutical distributors and investors.

Overview of Bromsite Manufacturing and Supply Chain Dynamics
Bromsite is primarily marketed by Bausch + Lomb, a major pharmaceutical entity specializing in ophthalmic products. The active pharmaceutical ingredient (API), bromfenac, must meet stringent standards delineated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulatory frameworks influence the selection, validation, and operations of suppliers involved in Bromsite’s supply chain.

Given its specific formulation (0.075% bromfenac ophthalmic solution), Bromsite's sourcing involves high-quality API manufacturers, excipient suppliers, and fill-finish facilities. Typically, manufacturers need to source bromfenac from reputable API producers before formulation, packaging, and distribution.

Key Suppliers of Bromfenac (Active Pharmaceutical Ingredient)

1. Taiwan-based API Manufacturers
   Taiwan hosts several API producers known for high-quality pharmaceutical ingredients, including bromfenac. Companies such as CSI Laboratories and Power Chemical supply bromfenac APIs to pharmaceutical companies globally. They hold Good Manufacturing Practice (GMP) certifications aligning with international standards, ensuring regulatory compliance and product safety.

2. Chinese API Producers
   China remains a dominant supplier of API ingredients due to its extensive manufacturing capacity. Companies like Hengan Group and Zhejiang Huanyu Pharmaceutical are known to produce bromfenac APIs for export markets. Regulatory scrutiny is high, requiring rigorous quality assurance and audits by procurement companies.

3. European and North American API Suppliers
   European firms such as Polpharma (Poland) and North American firms like Amneal Pharmaceuticals occasionally produce bromfenac APIs under strict GMP conditions. Certification and detailed quality documentation are prerequisites for their API to be sourced for ophthalmic applications.

Manufacturers of Bromsite Finished Product

1. Bausch + Lomb
   The primary and exclusive manufacturer of Bromsite, Bausch + Lomb, maintains an integrated supply chain that sources API from trusted providers. Their in-house formulation and sterilization facilities ensure product quality, stability, and compliance with regulatory standards. As the product is protected under patents and proprietary formulations, negotiations with Bausch + Lomb for supply or licensing are common for generic entrants.

2. Authorized Generic Suppliers
   While Bromsite is mainly marketed by Bausch + Lomb, some generic manufacturers produce bromfenac ophthalmic solutions. These manufacturers typically source bromfenac API from third-party producers and undertake their own formulation, manufacturing, and distribution processes, subject to regulatory approval.

Regulatory Considerations and Certification
Suppliers must possess relevant certifications, including GMP compliance, ISO certification, and FDA/EMA approval if manufacturing for markets in the US and Europe. Regulatory audits ensure that production processes meet strict quality criteria, critical for ophthalmic solutions that require sterility and stability.

Emerging Trends and Supply Chain Challenges

• Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, causing delays or shortages of APIs and finished products. Ensuring diversified sourcing from multiple qualified suppliers remains critical.

• Regulatory Shifts: Evolving international regulations, such as the US Drug Supply Chain Security Act (DSCSA), increase traceability requirements, urging manufacturers to enhance supply chain transparency.

• Generic Market Entry: Patent expirations and the increased demand for ophthalmic NSAIDs have prompted generic companies to develop Bromsite alternatives, often sourcing APIs from lower-cost regions while maintaining quality standards.

Conclusion
The supply landscape for Bromsite is characterized by a limited but globally distributed network of high-quality API producers, predominantly located in Taiwan, China, and Europe, complemented by manufacturing giants like Bausch + Lomb. Ensuring a robust supply chain hinges upon strict adherence to regulatory standards, quality assurance, and diversified procurement strategies. Stakeholders should prioritize compliance and transparency while monitoring geopolitical and regulatory developments influencing supply stability.

Key Takeaways

• Bromsite’s active ingredient, bromfenac, is sourced mainly from certified API manufacturers in Taiwan, China, and Europe.
• Bausch + Lomb remains the sole producer of the branded Bromsite ophthalmic solution, leveraging its integrated supply chain.
• Regulatory compliance, especially GMP certification and international approvals, is vital for supply chain integrity.
• The global supply chain faces risks from geopolitical shifts, pandemics, and regulatory changes, necessitating diversified sourcing strategies.
• Emerging markets and generic manufacturers are increasingly sourcing bromfenac APIs, providing competitive alternatives but requiring rigorous quality checks.

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FAQs

1. Who are the primary API suppliers for Bromsite?
Major API suppliers include manufacturers in Taiwan (CSI Laboratories, Power Chemical), China (Hengan Group, Zhejiang Huanyu), and European firms like Polpharma. These entities produce bromfenac API under GMP standards to meet global pharmaceutical requirements.

2. Is Bromsite produced solely by Bausch + Lomb?
Yes, Bausch + Lomb is the exclusive manufacturer of Bromsite. Generic versions may exist, but they typically source bromfenac from third-party API producers and must obtain regulatory approval.

3. What regulatory standards must Bromsite suppliers meet?
Suppliers must comply with GMP certifications, ISO standards, and regulatory approvals such as FDA or EMA accreditation to ensure API quality and safety for pharmaceutical use.

4. How have recent supply chain disruptions affected Bromsite production?
Disruptions from global events like the COVID-19 pandemic have caused delays in API shipments and finished product manufacturing. Diversified sourcing and strategic inventory management mitigate these risks.

5. Are there emerging suppliers or markets for Bromsite?
Yes, generic manufacturers in India and Southeast Asia are developing bromfenac ophthalmic solutions, often sourcing APIs from established producers. Certification and quality assurance are critical for market entry.

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Sources

1. U.S. Food and Drug Administration (FDA). [FDA GMP Guidelines].
2. European Medicines Agency (EMA). [Regulatory Framework for Ophthalmic Drugs].
3. Industry reports on API manufacturing markets (e.g., IQVIA, PharmSource).
4. Company websites: Bausch + Lomb, CSI Laboratories, Zhejiang Huanyu Pharmaceutical.
5. Market analysis articles on ophthalmic drug supply chains (e.g., GlobalData, EvaluatePharma).