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Suppliers and packagers for prolensa
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prolensa
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 | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168 | NDA | Bausch & Lomb Incorporated | 24208-602-03 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER | 2013-04-05 |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168 | NDA | Bausch & Lomb Incorporated | 24208-602-04 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER | 2013-04-05 |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168 | NDA | Bausch & Lomb Incorporated | 24208-602-06 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 mL in 1 BOTTLE, DROPPER | 2013-04-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Prolensa
Introduction
Prolensa (bromfenac ophthalmic solution) is a non-steroidal anti-inflammatory drug (NSAID) used primarily to treat postoperative ocular inflammation and pain associated with ocular surgeries, such as cataract extraction. Since its approval by the U.S. Food and Drug Administration (FDA) in 2010, Prolensa has become a vital part of ophthalmic treatment regimens. Access to reliable suppliers ensures consistent availability, quality, and regulatory compliance, essential for healthcare providers and distributors operating within global markets.
This article offers a comprehensive overview of primary suppliers for Prolensa, exploring manufacturing sources, distribution channels, and key considerations for procurement. The goal is to equip industry professionals with precise intelligence to optimize supply chain strategies.
Manufacturers and Licensed Distributors of Prolensa
1. Sun Pharmaceutical Industries Ltd.
Overview:
Sun Pharma developed and commercialized Prolensa after acquiring the rights from Bausch + Lomb, who originally marketed the drug (Bausch + Lomb was acquired by Bausch Health in 2013, but the rights for Prolensa have been held by various entities post-acquisition).
Supply Chain Role:
Sun Pharma is a major manufacturer and regional distributor within the United States and key markets in Asia and Europe. Their global manufacturing facilities adhere to cGMP standards, ensuring high-quality production.
Availability:
Prolensa is widely distributed through Sun Pharma’s extensive network, serving hospitals, clinics, and pharmacy chains. Their distribution infrastructure ensures timely delivery and regulatory compliance.
2. Bausch + Lomb (Part of Bausch Health Companies Inc.)
Overview:
Initially developed by Bausch + Lomb, Prolensa was marketed under their portfolio. Post-2013, Bausch + Lomb has continued to serve as a licensor/licensee for certain markets, although the drug’s manufacturing rights have been transitioned to Sun Pharma in some regions.
Supply Chain Role:
In regions where Bausch + Lomb retains licensing rights, they serve as primary suppliers and distributors, leveraging their well-established ophthalmic distribution channels.
Availability:
Their global footprint within ophthalmology ensures accessibility across North America, Europe, and select Asia-Pacific markets.
Other Key Suppliers and Distributors
3. Generic Manufacturers (Emerging and Regional)
While no direct generic equivalents of Prolensa have obtained FDA approval to date, several regional manufacturers and compounding pharmacies produce bromfenac ophthalmic solutions that mimic Prolensa's formulation.
- Pharmaceutical compounding pharmacies: These entities often produce bromfenac formulations for clinical or compassionate use, though these are not standardized commercial products.
- Regional generics: In markets like India, China, and Southeast Asia, several pharmaceutical firms manufacture bromfenac-based ophthalmic solutions, sometimes marketed under different brand names or as private-label products.
Note: Legal and regulatory jurisdiction varies; procurement from these sources should prioritize licensing, regulatory approval, and quality assurance.
4. Global Pharmaceutical Distribution Partners
Major international pharma distributors—such as McKesson, Cardinal Health, and Henry Schein—serve as intermediaries for ophthalmic drugs, including Prolensa, especially within the United States. These entities partner with licensed manufacturers to ensure broad access to the product.
Regional Supply Considerations
-
North America:
Predominantly supplied by Bausch + Lomb and Sun Pharma, with distribution managed through hospital systems and retail pharmacy chains. -
Europe:
Distribution primarily handled via Bausch + Lomb and approved regional generic manufacturers, subject to European Medicines Agency (EMA) regulations. -
Asia-Pacific:
Sun Pharma and regional manufacturers dominate, influenced by local regulatory approvals and market demand. -
Emerging Markets:
Depend heavily on regional generics and compounded formulations, often with limited access to branded Prolensa.
Regulatory & Quality Assurance Factors
Procurement from authorized suppliers is critical due to the stringent regulatory landscape governing ophthalmic drugs. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), possess proper licenses, and adhere to pharmacovigilance standards.
Unauthorized or unapproved sources pose risks related to drug efficacy, safety, and legal liability. Therefore, buyers should verify supplier credentials, including FDA registration numbers, manufacturing licenses, and compliance certificates.
Supply Chain Challenges and Opportunities
-
Supply Disruptions:
Global manufacturing shifts, raw material shortages, or regulatory changes could affect supply, emphasizing the need for diversified sourcing strategies. -
Market Expansion:
Increasing prevalence of ocular surgeries fuels demand, creating opportunities for established and emerging suppliers to expand market share. -
Regulatory Approvals:
As newer formulations like Prolensa generate interest in biosimilars or generics, suppliers with robust R&D capabilities may acquire or develop alternative options, impacting the supply landscape.
Key Takeaways
-
Prolensa is primarily supplied by Sun Pharmaceutical Industries Ltd. and Bausch + Lomb, with their distribution networks ensuring worldwide availability within approved markets.
-
Reliable procurement depends on verifying licenses, regulatory compliance, and manufacturing quality standards to mitigate risks associated with counterfeit or substandard products.
-
Regional and emerging market suppliers provide alternative options, especially where branded products face supply constraints or regulatory hurdles.
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Continuous market monitoring and diversification strategies can help stakeholders address supply chain disruptions and capitalize on increasing ophthalmic procedural volumes.
FAQs
1. Who are the main manufacturers of Prolensa globally?
Sun Pharmaceutical Industries Ltd. and Bausch + Lomb are the primary manufacturers and suppliers of Prolensa in different regions, with Sun Pharma holding significant manufacturing rights post-2013.
2. Can I source Prolensa from generic manufacturers?
No FDA-approved generic formulations of Prolensa currently exist. However, regional manufacturers produce bromfenac ophthalmic solutions, often under different brand names or private labels, for regional markets.
3. What should healthcare providers consider when procuring Prolensa?
Providers must verify supplier licensing, regulatory approvals, and adherence to GMP standards to ensure drug safety, efficacy, and compliance.
4. Are there regional restrictions on Prolensa’s supply?
Yes. Regulatory approval status varies by country. In some regions, Prolensa is available via licensed distributors; in others, only regional generics or compounded formulations are accessible.
5. How can supply chain disruptions for Prolensa be mitigated?
Diversify sourcing channels, maintain stock buffers, collaborate with established distributors, and monitor regulatory updates to promptly adapt procurement strategies.
Sources
- U.S. Food & Drug Administration. Prolensa (bromfenac ophthalmic solution) approval details. [FDA.gov]
- Bausch + Lomb corporate website. Product portfolio and licensing info. [BauschLomb.com]
- Sun Pharmaceutical Industries Ltd. official site. Manufacturing and distribution overview. [Sunpharma.com]
- World Health Organization. Essential Medicines List. Ophthalmic drugs industry insights. [WHO.int]
- Market analysis reports—Global Ophthalmic Drugs Market, 2022.
In conclusion, procurement of Prolensa relies heavily on a select group of licensed manufacturers, with regional variations driven by regulatory landscapes. Strategic partnerships, thorough due diligence, and proactive supply chain management are essential for ensuring uninterrupted access to this critical ophthalmic medication.
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