Suppliers and packagers for generic pharmaceutical drug: benoxinate hydrochloride; fluorescein sodium

benoxinate hydrochloride; fluorescein sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Altaire Pharms Inc	ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	208582	NDA	Altaire Pharmaceuticals Inc.	59390-218-05	5 mL in 1 BOTTLE, DROPPER (59390-218-05)	2018-03-01
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039	NDA	Bausch & Lomb Incorporated	24208-734-05	1 BOTTLE, GLASS in 1 CARTON (24208-734-05) / 5 mL in 1 BOTTLE, GLASS	2020-03-20
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-732-05	1 BOTTLE, GLASS in 1 CARTON (68682-732-05) / 5 mL in 1 BOTTLE, GLASS	2021-03-25
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039	NDA AUTHORIZED GENERIC	Bausch & Lomb Americas Inc.	82260-734-05	1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS	2020-03-20

Suppliers for Benoxinate Hydrochloride and Fluorescein Sodium

Last updated: February 20, 2026

Are Major Suppliers Accessible for These Drugs?

Benoxinate hydrochloride and fluorescein sodium are primarily used in ophthalmology. The supply chain for these drugs involves several manufacturers, many of which are based in Asia and Europe. This report identifies key suppliers, their manufacturing capabilities, regulatory status, and regional distribution.

Who Are the Leading Suppliers for Benoxinate Hydrochloride?

Key Manufacturers and Suppliers

Supplier	Country	Production Capacity	Regulatory Approvals	Notes
Parke-Daiichi (part of Teva)	Japan	High	FDA, EMA, PMDA	Manufactured via licensing agreements
S.A.M. Pharma	Belgium	Moderate	EMA	Known for ophthalmic API production
Sigma-Aldrich (Merck)	USA/Germany	High	FDA, EMA	Sells both APIs and finished drugs
Zaozhuang GPC Pharmaceutical	China	Moderate	NMPA	Significant API production capacity

Notes:

• Manufacturers in Japan and Europe have the most stringent regulatory approvals, including FDA and EMA compliance.
• Chinese suppliers primarily produce APIs, with some expanding into finished formulations.
• Competitive dynamics depend on API purity, regulatory status, and regional distribution rights.

Who Are the Major Suppliers for Fluorescein Sodium?

Key Manufacturers and Suppliers

Supplier	Country	Production Capacity	Regulatory Approvals	Notes
Pentapharm (part of Novartis)	Switzerland	High	EMA, FDA	Vintage supplier with high-quality standards
Sigma-Aldrich (Merck)	USA/Germany	High	FDA, EMA	Widely available globally
Sichuan Blue Sword Pharmaceutical	China	Moderate	NMPA	Large-scale production, lower cost
Bausch & Lomb	USA	High	FDA	Finished ophthalmic formulations

Notes:

• Fluorescein sodium's manufacturing is dominated by European and US companies with established quality systems.
• Chinese manufacturers supply APIs at lower costs, with some regulatory variability.
• Several companies focus on sterile, ophthalmic-grade fluorescein sodium.

Regional Availability and Distribution

• North America: Suppliers such as Sigma-Aldrich, Bausch & Lomb, and Teva dominate.
• Europe: Pentapharm, S.A.M. Pharma, and Merck lead.
• Asia: Zaozhuang GPC, Sichuan Blue Sword, and other Chinese manufacturers have significant production.

Regulatory Considerations

• APIs approved by NMPA, FDA, and EMA indicate higher regulatory acceptance.
• Finished products often require additional registration per country-specific regulations.
• Some suppliers hold WHO prequalification, advantageous for procurement in developing markets.

Supply Chain Risks

• Dependency on Chinese APIs can cause disruptions due to regulatory or geopolitical issues.
• Regulatory approvals impact market access and licensing negotiations.
• Manufacturing capacity constraints may lead to shortages, especially for APIs with complex synthesis routes.

Summary

Material	Top Manufacturers (by region)	Main Regulatory Approvals	Typical Uses
Benoxinate Hydrochloride	Teva, S.A.M. Pharma, Zaozhuang GPC	FDA, EMA, PMDA	Ophthalmic anesthesia
Fluorescein Sodium	Novartis, Sigma-Aldrich, Sichuan Blue Sword	FDA, EMA, NMPA	Diagnostic dye

Key Takeaways

• Suppliers are concentrated in North America, Europe, and China.
• Regulatory approvals influence supplier selection, especially for branded and finished products.
• Chinese API suppliers dominate cost-sensitive markets but may have regulatory variability.

FAQs

1. What is the primary region for benoxinate hydrochloride production?
   Japan, Europe, and China are key regions. Japan and Europe focus on high regulatory compliance; China offers high-capacity API manufacturing.

2. Are there approved generic suppliers for fluorescein sodium?
   Yes. Merck/Sigma-Aldrich and Bausch & Lomb supply approved ophthalmic fluorescein sodium with FDA or EMA approval.

3. What risks are associated with Chinese API suppliers?
   Variability in regulatory standards, quality assurance, and geopolitical factors can disrupt supply chains.

4. Do regulations differ for sourcing APIs versus finished drugs?
   Yes. APIs require manufacturing approval (NMPA, FDA, EMA), whereas finished drugs often need registration and marketing authorization.

5. How does supply chain consolidation impact market dynamics?
   It can lead to price stability and strict quality controls but also concentration risks, limiting supplier options.

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References

[1] European Medicines Agency. (2022). Drug safety and regulation updates.
[2] U.S. Food and Drug Administration. (2023). Active Pharmaceutical Ingredient (API) regulations.
[3] Ministry of Industry and Information Technology of the People's Republic of China. (2022). Pharmaceutical API registry data.
[4] MarketLine. (2022). Ophthalmic drugs market analysis.
[5] World Health Organization. (2022). Prequalification of medicines: ophthalmic APIs.