Suppliers and packagers for ACULAR LS

ACULAR LS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA	Allergan, Inc.	0023-9277-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER	2003-08-19
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-3550-0	1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER	2013-11-21
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-773-05	1 BOTTLE, DROPPER in 1 CARTON (60758-773-05) / 5 mL in 1 BOTTLE, DROPPER	2013-11-21

Suppliers for the Pharmaceutical Drug: Acular LS

Last updated: July 28, 2025

Introduction

Acular LS (Ketorolac Tromethamine Ophthalmic Suspension) is a non-steroidal anti-inflammatory drug primarily prescribed to alleviate ocular inflammation and pain following ophthalmic procedures or trauma. As a specialized ophthalmic formulation, Acular LS demands specific manufacturing quality standards and regulatory compliance. Its supply chain involves diverse stakeholders, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors. Understanding key suppliers is critical for pharmaceutical companies, healthcare providers, and investors aiming to ensure product availability, quality, and cost-competitiveness.

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Overview of Acular LS Supply Chain

The supply chain for Acular LS encompasses three core stages:

1. API Production — raw material synthesis of ketorolac tromethamine.
2. Formulation and Packaging — conversion of API into the ophthalmic suspension.
3. Distribution and Logistics — delivery to healthcare markets.

Each stage involves multiple suppliers, with the API component being the foundational element. Ensuring supplier reliability, regulatory compliance, and quality control is vital to maintaining the integrity and consistent supply of Acular LS.

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API Suppliers for Ketorolac Tromethamine

Ketorolac Tromethamine, the active ingredient in Acular LS, is synthesized globally by several leading pharmaceutical ingredient manufacturers. Key suppliers include:

• Hetero Labs (India): A prominent manufacturer of APIs, including NSAIDs like ketorolac, Hetero Labs supplies to multiple ophthalmic medicine producers globally. Their facilities are GMP-certified, with robust quality assurance programs.

• Mundipharma International (UK): Known to produce proprietary formulations of ketorolac, serving both ophthalmic and systemic indications. Their API manufacturing complies with international standards, including EMA and FDA regulations.

• Sicolid (China): A growing API producer with capabilities in NSAID synthesis, Sicolid supplies ketorolac tromethamine to several generic ophthalmic drug manufacturers.

• Daiichi Sankyo (Japan): While primarily focused on proprietary pharmaceuticals, Daiichi Sankyo handles high-quality APIs and may serve as a reliable supplier for licensed production partners.

• Lupin Limited (India): A significant global API supplier, Lupin offers ketorolac tromethamine with a focus on quality and cost-efficiency.

Note: Several other regional API manufacturers in Europe, Asia, and North America also produce ketorolac tromethamine, often supplying under strict regulatory contracts.

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Formulation and Finished Product Manufacturers

Acular LS is a proprietary ophthalmic suspension formulated by Allergan (now part of AbbVie), which holds the brand rights in multiple markets. While Allergan manages the formulation manufacturing, many regional manufacturing partners assist in blistering, bottling, and packaging operations.

• AbbVie (formerly Allergan): The exclusive marketer and manufacturer of Acular LS, operating its own formulation facilities compliant with cGMP standards.

• Contract Manufacturing Organizations (CMOs): Several CMOs across Europe, North America, and Asia are licensed or contracted for formulation, such as:

  • Catalent Pharma Solutions (USA): Provides sterile ophthalmic formulation services.

  • Recipharm (Sweden): Known for sterile ophthalmic formulations.

  • Famar (Greece): Offers formulation capabilities for ophthalmic products.

Packaging Suppliers

The packaging materials, including bottles, droppers, and labels, are supplied by specialized packaging companies that meet ophthalmic safety standards.

• Gerresheimer (Germany): Supplies high-quality ophthalmic droppers and containers.

• Ompi (Stevanato Group): Provides sterile, pre-sterilized vials and packaging solutions.

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Distribution Partners

Distribution involves logistics providers meeting regulatory standards for ophthalmic medications, ensuring cold-chain (if applicable) and stability during transit.

Major distributors include:

• McKesson Corporation (USA): Distributes to North American markets.

• Alliance Healthcare (Europe): Handles European distribution networks.

• APEX Pharma (India): Serves the South Asian market.

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Regulatory and Quality Assurance Considerations

Suppliers for Acular LS must satisfy rigorous regulatory standards, including:

• Good Manufacturing Practices (GMP): Ensured by authorities such as the FDA (USA), EMA (Europe), and PMDA (Japan).

• Licensing Agreements: Allergan/AbbVie's licensing agreements with regional manufacturers often stipulate stringent quality benchmarks.

• Batch Certification & Lot Traceability: Critical for API and formulation providers to facilitate audit trails and ensure batch consistency.

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Emerging Trends and the Impact of Global Supply Chains

The COVID-19 pandemic underscored vulnerabilities within global pharmaceutical supply chains. Suppliers like Sinopharm and other Chinese API manufacturers have gained prominence, emphasizing diversification of API sourcing to reduce bottlenecks. Nonetheless, the complexity, regulatory environment, and necessity for sterile, high-purity ophthalmic formulations mean supplier choices remain curated for quality and regulatory compliance.

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Conclusion

The supply landscape for Acular LS exemplifies a multi-tiered pharmaceutical supply chain comprising reputable API manufacturers like Hetero Labs, Lupin, and Sicolid, alongside formulation specialists such as Catalent and Recipharm. Ensuring steady access to high-quality ingredients and finished products hinges on strict regulatory adherence, supplier diversification, and robust logistics networks. Companies aiming to secure or expand supply should prioritize relationships with certified manufacturers and continuously monitor geopolitical and regulatory developments influencing pharmaceutical sourcing.

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Key Takeaways

• API Diversity Is Crucial: Relying on multiple reputable API suppliers like Hetero Labs and Lupin mitigates supply risks.

• Regulatory Compliance Matters: Suppliers must meet GMP standards mandated by global health authorities to ensure product safety and efficacy.

• Contract Manufacturers Play a Strategic Role: CMOs like Catalent and Recipharm help maintain manufacturing flexibility and technological innovation.

• Supply Chain Resilience Is Essential: Diversification and rigorous quality assurance safeguard against disruptions, especially for ophthalmic formulations demanding sterile, high-purity ingredients.

• Market Dynamics Influence Suppliers: Geopolitical factors, such as pandemic-related supply chain disruptions, can shift sourcing strategies and supplier reliance.

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FAQs

1. Who are the primary API suppliers for ketorolac tromethamine used in Acular LS?
Leading API suppliers include Hetero Labs (India), Lupin Limited (India), Sicolid (China), and Daiichi Sankyo (Japan). They provide high-quality ketorolac tromethamine, adhering to international standards.

2. Are there regional differences in Acular LS suppliers?
Yes. While Allergan/AbbVie manages formulation and distribution in major markets, regional licensing agreements sometimes involve local manufacturers, influencing the supplier landscape and regulatory compliance standards.

3. How does regulatory compliance affect supplier choice?
Suppliers must comply with global GMP standards, demonstrate batch consistency, and pass inspections from agencies like the FDA, EMA, or PMDA, ensuring safety and efficacy of the ophthalmic suspension.

4. What role do contract manufacturing organizations play in the Acular LS supply chain?
CMOs handle formulation, manufacturing, and packaging, offering scalability, quality control, and technological expertise, especially critical for sterile ophthalmic products like Acular LS.

5. How might geopolitical or global health events impact Acular LS's supply chain?
Events like the COVID-19 pandemic or trade restrictions can disrupt API supply chains, prompting manufacturers to diversify sources and strengthen inventory buffers to maintain consistent product availability.

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References

1. [1] Hetero Labs. (2022). API manufacturing capabilities. Hetero.com.
2. [2] Lupin Limited. (2022). API Portfolio. LupinGlobal.com.
3. [3] Sicolid. (2022). API production standards. Sicolid.cn.
4. [4] Catalent Pharma Solutions. (2022). Ophthalmic formulation services. Catalent.com.
5. [5] United States Food and Drug Administration (FDA). (2022). Good Manufacturing Practices (GMP) standards. FDA.gov.

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Disclaimer: This overview reflects the known supply chain landscape for Acular LS as of 2023. Suppliers and manufacturing arrangements are subject to change based on regulatory, commercial, and geopolitical factors.