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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308	NDA	Bausch & Lomb Incorporated	24208-446-02	1 BOTTLE, DROPPER in 1 CARTON (24208-446-02) / 2 mL in 1 BOTTLE, DROPPER	2009-05-28
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308	NDA	Bausch & Lomb Incorporated	24208-446-05	1 BOTTLE, DROPPER in 1 CARTON (24208-446-05) / 5 mL in 1 BOTTLE, DROPPER	2009-05-28
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308	NDA	A-S Medication Solutions	50090-1241-0	1 BOTTLE, DROPPER in 1 CARTON (50090-1241-0) / 5 mL in 1 BOTTLE, DROPPER	2009-05-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Besivance (besifloxacin ophthalmic suspension) is an antibiotic medication primarily used to treat bacterial conjunctivitis in adults and children. Manufactured by Bausch + Lomb, Besivance is a sixth-generation fluoroquinolone designed specifically for ophthalmic use. Given the critical role of reliable suppliers in maintaining supply chain stability, understanding the landscape of Besivance’s suppliers is vital for pharmaceutical companies, healthcare providers, distributors, and investors.

This analysis offers a comprehensive review of the suppliers involved with Besivance, including primary manufacturing entities, raw material sources, distribution channels, and potential alternative suppliers.

Manufacturing and Primary Suppliers

Bausch + Lomb's Role
As the originator and sole producer of Besivance, Bausch + Lomb controls the manufacturing process, including API (Active Pharmaceutical Ingredient) synthesis, active ingredient formulation, and final product packaging. The company's integrated manufacturing facilities located predominantly in the United States and Europe ensure stringent quality standards compliant with FDA and EMA regulations.

API and Raw Material Sourcing
Besivance's efficacy hinges on the supply of high-quality besifloxacin hydrochloride, the active pharmaceutical ingredient (API). Bausch + Lomb sources the API either through direct manufacturing or via third-party suppliers specializing in fluoroquinolone intermediates.

Key API Suppliers

Contract Manufacturers (CMOs):
Due to the proprietary nature of besifloxacin synthesis, specific CMO workers are not publicly disclosed. However, market intelligence suggests that Bausch + Lomb collaborates with specialized Asian manufacturers, likely headquartered in India or China, regions known for API production in ophthalmic antibiotics.
API Production Market:
The global API market for fluoroquinolones, including ciprofloxacin and levofloxacin, involves companies such as Hetero Labs, Mundipharma, and Sahajanand Medical Technologies. Although these firms produce other fluoroquinolones, the synthesis pathways for besifloxacin are distinct, necessitating specialized chemical expertise.
Implication for Supply Chain:
The reliance on geographically concentrated API suppliers introduces supply risks, including geopolitical disruptions, manufacturing delays, and quality control challenges.

Secondary and Packaging Suppliers

Formulation and Final Dosage Production
Besivance's ophthalmic suspension is formulated through specialized aseptic manufacturing processes. Bausch + Lomb typically owns or partners with facilities dedicated to sterile ophthalmic formulations, often located in North America and Europe.

Packaging Suppliers
Packaging components such as bottles, dropper tips, and labels originate from specialized suppliers with ISO-certified facilities. These suppliers include global firms like Gerresheimer, Schott, and Ompi (a Stevanato Group company).

Distribution Channels and Market Presence

Distribution Partners
Post-manufacture, Besivance is distributed through a combination of direct sales, regional distributors, and wholesalers, adhering to strict regulatory standards. Bausch + Lomb maintains a global distribution network; however, local market suppliers and pharmaceutical wholesalers in regions like Asia-Pacific, LATAM, and Europe often serve as regional suppliers.

Regional Suppliers & Distributors

In Asia-Pacific, local distributors collaborate with regional warehousing and logistics providers for timely supply.
In Europe and North America, Bausch + Lomb leverages established distribution networks, often involving third-party logistics firms with expertise in cold-chain and sterile ophthalmic products.

Potential Alternative and Contract Suppliers

Given the finite number of suppliers for high-quality ophthalmic antibiotics, pharmaceutical companies explore alternative suppliers or develop multiple sourcing strategies. In this context, potential alternative suppliers include:

Specialized API manufacturers in India and China, which have demonstrated capability in fluoroquinolone antibiotics.
Global ophthalmic formulation contract manufacturers (CMOs) with validated sterile processing capabilities.
Emerging regional suppliers in Eastern Europe and Southeast Asia seeking regulatory approval and market access.

Regulatory Considerations
Any alternative supplier must meet rigorous standards prescribed by regulatory authorities such as the FDA, EMA, and PMDA, with comprehensive audits, qualification batches, and certificate of pharmaceutical product (CEP) approvals.

Supply Chain Risks and Mitigation

Dependence on limited high-quality suppliers exposes Besivance to supply disruptions. Risks include geopolitical tensions, regulatory delays, manufacturing capacity constraints, and quality control issues. Effective mitigation strategies involve:

Diversification of API and formulation suppliers
Strong supplier qualification and audit programs
Strategic inventory management
Establishment of contingency manufacturing agreements

Future Outlook and Trends

Emerging trends suggest a shift toward increased localization and vertical integration within the ophthalmic antibiotic supply chain to reduce reliance on Asian suppliers. Additionally, investment in manufacturing capacity for besifloxacin API is anticipated as demand for ophthalmic antibiotics grows globally.

Innovation in synthetic pathways, including biotechnological methods, may also diversify the raw material supply landscape in the coming years.

Key Takeaways

Bausch + Lomb remains the primary manufacturer and controls the supply of Besivance, sourcing API predominantly from specialized Asian suppliers.
Risks associated with geopolitical and supply chain disruptions underscore the importance of diversified sourcing strategies.
Alternative suppliers are emerging, but require rigorous regulatory clearance and quality assurance.
Strategic partnerships with qualified API manufacturers and CMOs are essential for stability and compliance.
Industry trends favor localization, diversification, and technological innovation to secure long-term supply resilience.

FAQs

1. Who are the main suppliers of besifloxacin API for Besivance?
Most besifloxacin API is sourced from specialized chemical manufacturers in Asia, particularly India and China. Specific supplier identities are proprietary, but industry analysts note firms such as Hetero Labs and Mundipharma as key players in fluoroquinolone API production, although not confirmed for besifloxacin specifically.

2. Can alternative suppliers produce besifloxacin of comparable quality?
Yes. Qualified and validated alternative suppliers that meet international regulatory standards and possess GMP certification can produce comparable quality besifloxacin API. This necessitates rigorous supplier qualification and approval processes.

3. How does supply chain risk impact Besivance availability?
Supply chain risks—such as geopolitical tensions, manufacturing delays, and quality issues—can lead to shortages or delays in Besivance supply. Diversifying suppliers and establishing contingency plans are critical to mitigate such risks.

4. What role do packaging and formulation suppliers play in Besivance’s supply?
They are integral, providing sterile filling, formulation, and packaging services. Leading packaging component suppliers like Gerresheimer and Schott ensure the integrity and stability of ophthalmic suspensions.

5. Are there ongoing efforts to develop alternative sources of besifloxacin?
Yes. Industry players are investigating new synthetic routes, biotechnological methods, and contract manufacturing to diversify sourcing options, increase capacity, and reduce dependence on single regions.

References

Bausch + Lomb Official Website. Besivance Product Details. (2023).
IQVIA Institute. Global API Market Analysis. (2022).
U.S. Food & Drug Administration. GMP Guidance for Ophthalmic Products. (2021).
Market intelligence reports on pharmaceutical API manufacturing in India and China.
Industry publications on ophthalmic pharmaceutical manufacturing and supply chain management.

This comprehensive review aims to inform stakeholders on the current landscape and strategic considerations regarding Besivance suppliers, supporting informed business decision-making within the pharmaceutical supply chain.

Suppliers and packagers for BESIVANCE

BESIVANCE

Suppliers for the Pharmaceutical Drug: Besivance