LUMIFY PRESERVATIVE FREE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424	NDA	Bausch & Lomb Incorporated	24208-538-05	5 AMPULE in 1 POUCH (24208-538-05) / .4 mL in 1 AMPULE	2025-01-01
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424	NDA	Bausch & Lomb Incorporated	24208-538-20	4 POUCH in 1 CARTON (24208-538-20) / 5 AMPULE in 1 POUCH / .4 mL in 1 AMPULE	2025-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

LUMIFY Preservative-Free is a topical eye drop marketed primarily for reducing eye redness. Its preservative-free formulation caters to patients with sensitive eyes, dry eye syndrome, or those requiring long-term use without preservatives that may cause irritation. As demand for preservative-free ophthalmic solutions grows, identifying reliable suppliers becomes critical for pharmaceutical companies, healthcare providers, and distributors. This article provides a comprehensive overview of the sourcing landscape for LUMIFY Preservative-Free, including active ingredient suppliers, packaging providers, and contract manufacturing organizations (CMOs).

Overview of LUMIFY Preservative-Free

LUMIFY Preservative-Free is a product developed by Bausch + Lomb. Its active ingredient is Brimonidine Tartrate, an alpha-2 adrenergic receptor agonist, formulated to diminish eye redness. The preservative-free aspect involves sterile, single-use drop formulations, usually packaged in unit-dose vials. The complexity of producing preservative-free ophthalmic solutions necessitates specialized suppliers capable of delivering high-purity ingredients and sterile, multi-dose packaging components.

Active Pharmaceutical Ingredient (API) Suppliers

Brimonidine Tartrate, the active component of LUMIFY Preservative-Free, must be sourced from certified API manufacturers adhering to strict quality standards such as cGMP (current Good Manufacturing Practice).

Top API Suppliers

Sichuan Weikeqi Pharmaceutical Co., Ltd.
A prominent Chinese API supplier, Weikeqi provides high-quality Brimonidine Tartrate used in ophthalmic formulations. They possess robust cGMP certifications and have supplied to multiple ophthalmic drugs globally.
Aytu BioScience (U.S.-based, subsidiary of Sumitomo Dainippon Pharma)
They have historically utilized high-quality Brimonidine Tartrate sourced from multiple approved global suppliers, emphasizing purity and consistent supply chain management.
Tianjin Sikai Pharmaceutical Co., Ltd.
A well-established Chinese manufacturer with a USP and EP certification, offering Brimonidine Tartrate suitable for ophthalmic use.
Alkem Laboratories
An Indian pharmaceutical company with extensive API manufacturing capabilities, including alpha-adrenergic agents, certified for global markets.

Selection Criteria

Suppliers for the API must demonstrate:

cGMP certification
ISO 9001 certification
High-purity standards (USP/EP compliant)
Proven track record with ophthalmic APIs
Reliable supply chain and quality control processes

Packaging Suppliers for Preservative-Free Formulations

Preservative-free ophthalmic solutions demand specialized sterile packaging. Single-dose unit vials are common, requiring suppliers skilled in sterile filling and sealing operations.

Key Packaging Suppliers

West Pharmaceutical Services
A leader in unit-dose packaging for ophthalmic products, West offers pre-sterilized, leak-proof plastic droppers and vials compatible with preservative-free formulations.
Nemera (Fagron)
Known for sterile injectable and ophthalmic device manufacturing, Nemera supplies customized preservative-free dropper solutions with validated sterilization processes.
Stevanato Group
Offers pre-sterilized, ready-to-use ophthalmic containers that match regulatory requirements for preservative-free eye drops.
Gerresheimer
Supplies a wide range of ophthalmic glass and plastic primary containers, including preservative-free vial systems suitable for single-dose applications.

Considerations

Ensuring sterile integrity and leak-proof design
Compatibility with the API solution
Regulatory compliance (FDA, European Medicines Agency)
Scalability for large manufacturing runs

Contract Manufacturing and Fill-Finish Service Providers

Manufacturing preservative-free eye drops involves ultra-clean environments and validated sterile filling lines.

Leading CMOs

Catalent Pharma Solutions
Caters to ophthalmic products requiring aseptic filling of preservative-free solutions. Their facilities are validated for ophthalmic sterile production.
Recipharm
Provides fill-finish services for sterile ophthalmic solutions with proven expertise in preservative-free formulations.
Fareva
Specializes in sterile, ophthalmic drug manufacturing, including unit-dose preservative-free formulations, with comprehensive quality oversight.
Baxter BioPharma Solutions

With facilities equipped for sterile ophthalmic drug manufacturing, Baxter offers end-to-end services including packaging, lyophilization, and testing.

Supply Chain Considerations

The sourcing of LUMIFY Preservative-Free involves a multi-tiered supply chain requiring tight regulatory compliance and quality assurance. Manufacturers should evaluate:

Regulatory status of suppliers (FDA approval, EMA certification)
Traceability of raw materials
Quality control measures for sterile production
Lead times and capacity constraints
Supplier risk management to mitigate supply disruptions

Emerging Trends and Future Outlook

As the ophthalmic market expands, particularly with increased demand for preservative-free solutions, suppliers are investing in advanced technologies like laser sterilization, automated filling lines, and tamper-evident packaging. The industry is also witnessing a trend toward sourcing from regions with manufacturing cost advantages, such as India and China, while maintaining stringent quality standards to meet global regulatory requirements.

Furthermore, partnerships between pharmaceutical companies and specialized packaging providers are strengthening, aiming to streamline the supply chain and enhance product safety.

Key Takeaways

Active Ingredient Sourcing: Brimonidine Tartrate is primarily supplied by high-quality Chinese, Indian, and U.S.-based API manufacturers with cGMP certification.
Packaging Solutions: Leading sterile packaging providers like West Pharmaceutical Services and Nemera specialize in preservative-free ophthalmic unit-dose systems.
Manufacturing Expertise: Contract manufacturers with expertise in sterile eye drop production, such as Catalent and Recipharm, are essential for high-quality fill-finish operations.
Supply Chain Integrity: Ensuring compliance, traceability, and capacity is critical for uninterrupted supply of preservative-free products.
Market Trends: Increased demand for preservative-free formulations drives innovation and collaboration among API suppliers, packaging firms, and CMOs.

FAQs

1. What are the main qualities to look for in a supplier of Brimonidine Tartrate for ophthalmic use?
Supply chain reliability, cGMP certification, high purity standards (USP/EP compliance), proven ophthalmic API experience, and consistent quality control processes.

2. How is preservative-free ophthalmic packaging different from preserved formulations?
Preservative-free packaging uses sterile, single-dose units sealed in tamper-evident, leak-proof containers, often made from plastics or glass, eliminating the need for preservatives to prevent microbial growth.

3. Are there geographic considerations when sourcing suppliers for LUMIFY Preservative-Free?
Yes. While China and India are significant API and packaging sources due to cost advantages, suppliers must meet international regulatory standards. U.S. and European suppliers often provide higher assurance of compliance but at higher costs.

4. What regulatory standards govern the manufacturing of preservative-free ophthalmic drugs?
Standards include FDA cGMP regulations, EMA directives, ISO 13485 for medical devices (if applicable), and pharmacopeial standards such as USP and EP.

5. What are the biggest challenges in sourcing for preservative-free ophthalmic products?
Ensuring sterile processing, maintaining product stability, managing supply chain risks, and compliance with evolving regulatory standards.

References

[1] Bausch + Lomb. (2023). LUMIFY Preservative-Free Eye Drops Product Details.
[2] U.S. Food and Drug Administration. (2021). Current Good Manufacturing Practice (CGMP) Regulations.
[3] West Pharmaceutical Services. (2022). Sterile Ophthalmic Packaging Solutions.
[4] Catalent. (2023). Sterile Ophthalmic Manufacturing Capabilities.
[5] EMA. (2021). Guidelines on ophthalmic medicinal products.

Disclaimer: This article is for informational purposes only and does not constitute endorsement of any supplier or product. Buyers should conduct thorough due diligence aligning with their specific requirements.

Suppliers and packagers for LUMIFY PRESERVATIVE FREE