Suppliers and packagers for LOTEMAX SM

LOTEMAX SM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219	NDA	Bausch & Lomb Incorporated	24208-507-01	1 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE	2019-02-25
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219	NDA	Bausch & Lomb Incorporated	24208-507-02	1 BOTTLE in 1 CARTON (24208-507-02) / 5 g in 1 BOTTLE	2019-02-25
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219	NDA	Bausch & Lomb Incorporated	24208-507-07	1 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE	2019-02-25

Suppliers for the Pharmaceutical Drug: LOTEMAX SM

Last updated: August 1, 2025

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Introduction

LOTEMAX SM (loteprednol etabonate) ophthalmic suspension represents a critical therapeutic option for managing postoperative inflammation and ocular pain. As a corticosteroid formulated with advanced delivery technology, its supply chain comprises multiple manufacturers, distributors, and authorized suppliers that ensure product availability across global markets. This analysis provides an in-depth review of the key suppliers involved in the production and distribution of LOTEMAX SM, highlighting their roles, regulatory compliance, and market influence.

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Manufacturers and Original Developers

Bausch + Lomb, now a significant entity under the umbrella of Bausch Health Companies Inc., is the original innovator and primary manufacturer of LOTEMAX SM. Their extensive research and development efforts led to the drug’s approval and subsequent commercialization. Bausch + Lomb's manufacturing facilities are certified by major regulatory agencies including the U.S. Food and Drug Administration (FDA), ensuring production within Good Manufacturing Practice (GMP) standards.

Production Overview:

• Manufacturing of LOTEMAX SM involves specialized processes to preserve the stability of loteprednol etabonate.
• The formulation employs the proprietary Aktenol technology, which enhances bioavailability and minimizes systemic absorption.
• Bausch + Lomb maintains strict quality control across its production lines to meet international standards.

Regulatory Status:

• Approved by the FDA as an ophthalmic corticosteroid indicated for postoperative inflammation.
• Approved in multiple markets including Europe, Canada, and parts of Asia through respective health authorities, often via Bausch + Lomb subsidiaries or partners.

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Authorized Distributors and Regional Suppliers

Given the global demand for LOTEMAX SM, Bausch + Lomb collaborates through a network of authorized distributors that facilitate regional supply chains, ensuring wide accessibility.

North America:

• Bausch + Lomb Direct Sales: The manufacturer itself manages distribution in the U.S. and Canada.
• Authorized Distributors: Several pharmaceutical distributors such as Cardinal Health, McKesson, and AmerisourceB Bergen serve as channels for pharmacy and hospital supplies.

Europe:

• Bausch + Lomb UK Limited and affiliated regional entities oversee supply.
• Authorized Local Distributors: They include entities like Alliance Healthcare in the UK, which ensures compliance with local regulatory frameworks.

Asia and Pacific:

• Regional subsidiaries of Bausch + Lomb or licensed regional partners manage supply.
• Distributors like Takeda Pharmaceutical (Japan) play pivotal roles in regional distribution.

Emerging Markets:

• Local licensing agreements often empower regional pharmaceutical firms to manufacture and distribute LOTEMAX SM under Bausch + Lomb’s quality standards.

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Contract Manufacturers and Supply Chain Partners

While Bausch + Lomb primarily produces LOTEMAX SM, the complexity of pharmaceutical manufacturing entails collaboration with specialized contract manufacturing organizations (CMOs) to meet global demand and regulatory requirements.

Key roles of CMOs:

• Scaling up production during high-demand phases.
• Ensuring GMP-compliant manufacturing.
• Assisting with formulation development and stability testing.

Major CMOs engaged include:

• Catalent Pharma Solutions
• Baxter BioPharma Solutions
• Recipharm

These organizations support Bausch + Lomb by providing manufacturing capacity while adhering to regulatory rigor.

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Supply Chain Challenges and Considerations

Regulatory Compliance:

• Suppliers must comply with regional GMP standards, including FDA, EMA (European Medicines Agency), and other national agencies.
• Ensuring traceability and documentation transparency is crucial for maintaining market approval and avoiding recalls.

Global Disruptions:

• Supply chain disruptions, such as those caused by the COVID-19 pandemic, have affected production timelines and distribution logistics.
• Strategic stockpiling, diversified sourcing, and regional manufacturing subsidiaries mitigate such risks.

Patent and Licensing Impacts:

• Patent expirations and licensing agreements influence the entry of generic versions and thus, the number of suppliers in various markets.

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Emerging Suppliers and Generics

With patent expiration near or achieved by certain regions, generic pharmaceutical companies seek approval for biosimilar or equivalent products of loteprednol etabonate.

Key players include:

• Allergan (AbbVie): Previously held rights to several ophthalmic corticosteroids but has divested some rights.
• Local generics manufacturers in India, China, and other emerging markets, who are authorized by Bausch + Lomb or licensed to produce generics under regional regulatory agencies.

These entrants expand the supply ecosystem, often at competitive pricing, but their quality must adhere to stringent standards.

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Regulatory and Market Access

Approval Pathways:

• Suppliers and manufacturers must navigate complex regulatory pathways for each jurisdiction.
• The approval of manufacturing sites by agencies like the FDA or EMA is a prerequisite for market authorization.

Supply Agreements:

• Contractual arrangements typically specify exclusivity, pricing, and supply commitments.
• Strategic partnerships enable rapid market expansion.

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Conclusion

The supply landscape for LOTEMAX SM is characterized by Bausch + Lomb’s core manufacturing operations supported by extensive regional distributors, contract manufacturers, and licensed generics producers. The strength of this network ensures consistent product availability, regulatory compliance, and capacity to respond to global demands. Nonetheless, supply chain vulnerabilities necessitate ongoing risk management, diversification of manufacturing sources, and adherence to evolving regulatory standards.

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Key Takeaways

• Primary Manufacturer: Bausch + Lomb is the exclusive producer of LOTEMAX SM, with GMP-certified facilities and global regulatory approvals.
• Distribution Network: Regional subsidiaries and authorized distributors ensure extensive availability across markets.
• Contract Manufacturing: Partnerships with specialized CMOs support high-volume production and quality assurance.
• Market Dynamics: Patent expirations and regulatory approvals drive the emergence of generic suppliers, broadening the supply ecosystem.
• Supply Chain Resilience: Addressing logistical disruptions and regulatory shifts remains critical for sustained supply stability.

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FAQs

1. Who are the main suppliers of LOTEMAX SM globally?
Bausch + Lomb is the primary manufacturer and controls the global supply, with regional distributors and licensed generic manufacturers participating in specific markets.

2. Can generic versions of loteprednol etabonate be considered equivalent to LOTEMAX SM?
Yes, once approved via regulatory pathways such as Abbreviated New Drug Applications (ANDAs), generics are considered bioequivalent and therapeutically comparable to the branded formulation.

3. What are the quality standards for suppliers of LOTEMAX SM?
Suppliers must comply with GMP standards set by regulatory agencies like the FDA and EMA, ensuring consistent product quality, safety, and efficacy.

4. How do supply chain disruptions affect the availability of LOTEMAX SM?
Disruptions can lead to shortages, delays, and increased prices. Diversification of manufacturing sources and regional production capabilities are strategies to mitigate such risks.

5. Are there any recent developments in the supply chain for LOTEMAX SM?
Recent trends include the approval of biosimilar products, expansion of manufacturing partnerships, and regional licensing agreements to address increased demand and competition.

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References

1. Bausch + Lomb official website. https://www.bausch.com/
2. U.S. Food and Drug Administration. NDA approval documents for LOTEMAX SM.
3. European Medicines Agency. Summary of product characteristics for ophthalmic corticosteroids.
4. Market reports on ophthalmic pharmaceuticals and generic drug approvals.
5. Industry articles on supply chain management in ophthalmic pharmaceuticals.