Bulk Pharmaceutical API Sources for ACULAR LS

Bulk Pharmaceutical API Sources for ACULAR LS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		K1136_SIGMA
Molport		MolPort-003-666-507
Amadis Chemical		A838011

Bulk Active Pharmaceutical Ingredient (API) Sources for: ACULAR LS

Last updated: August 1, 2025

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Introduction

ACULAR LS (ketorolac tromethamine ophthalmic solution, 0.4%) is a non-steroidal anti-inflammatory drug (NSAID) indicated primarily for ocular inflammation and pain management following ocular surgery. As an ophthalmic formulation, the quality and sourcing of the active pharmaceutical ingredient (API), ketorolac tromethamine, are crucial for ensuring safety, efficacy, and regulatory compliance. The supply chain dynamics for APIs such as ketorolac are increasingly complex, influenced by geopolitical factors, manufacturing capacity, regulatory standards, and cost considerations. This article explores the global landscape of bulk API sources for ACULAR LS, emphasizing key manufacturers, sourcing trends, regulatory standards, and procurement strategies.

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Overview of Ketorolac Tromethamine API in Ophthalmic Use

Ketorolac tromethamine, a potent NSAID, inhibits cyclooxygenase enzymes to reduce prostaglandin synthesis, thereby diminishing inflammation and pain. The ophthalmic use necessitates high purity (generally >99%) and stringent quality controls to prevent adverse ocular reactions. The API's manufacturing process must adhere to current Good Manufacturing Practices (cGMP) to meet regulatory expectations set by agencies such as the FDA and EMA.

The API market for ophthalmic applications like ACULAR LS is relatively specialized, requiring APIs that are compliant with specific pharmacopeial standards, especially United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant monographs.

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Global API Production and Major Suppliers

1. U.S. and European Manufacturers

Top-tier API producers in the United States and Europe offer high-quality ketorolac tromethamine, often serving the pharmaceutical industry with cGMP certification and rigorous testing. These suppliers typically cater to both generic and branded pharmaceutical manufacturers.

• BASF
  A leading European API manufacturer with extensive experience in NSAIDs, BASF supplies high-purity ketorolac tromethamine globally. Known for adherence to strict quality standards, BASF's products are used by multiple ophthalmic drug makers.

• Catalent
  While primarily a development and manufacturing partner, Catalent offers custom synthesis and supply of high-quality APIs, including ketorolac tromethamine, meeting international regulatory standards.

• Albany Molecular Research Inc. (AMRI)
  Recognized for specialty chemicals and APIs, AMRI produces ketorolac tromethamine with compliance to cGMP and relevant pharmacopeial standards.

2. Asian Suppliers

Asian countries, notably India and China, are prominent hubs for bulk API manufacturing due to cost efficiencies and expanding production capacities.

• Saltigo (subsidiary of Lanxess), Germany-based but with manufacturing facilities in Asia, supplies high-purity APIs, including ketorolac tromethamine, to global markets.

• Hetero Labs Ltd. (India)
  Hetero is a significant API manufacturer with cGMP-compliant facilities producing ketorolac tromethamine. Their offerings are often cost-competitive while maintaining quality standards aligned with global regulatory requirements.

• Sun Pharmaceutical Industries Ltd. (India)
  Sun Pharma produces a broad portfolio of APIs, including NSAIDs, and supplies ketorolac tromethamine for ophthalmic formulations, with certifications aligning with US and EU standards.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
  This company supplies ketorolac tromethamine API to international markets, focusing on quality and cost-effective production.

• Qingdao Shuangxing Pharmaceutical Co., Ltd. (China)
  A notable manufacturer with cGMP facilities producing ketorolac tromethamine API for export.

3. Other Notable Suppliers

• Akorn Pharmaceuticals (USA)
  While more focused on finished dosage forms, Akorn sometimes sources APIs from third-party manufacturers for in-house formulations, emphasizing regulatory compliance.

• Leonhard Müllner GmbH & Co. KG (Germany)
  A supplier specializing in NSAID APIs, offering ketorolac tromethamine with high-grade purity.

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Sourcing Strategies and Considerations

Quality Assurance:
Ensuring API quality is paramount for ophthalmic preparations like ACULAR LS. Suppliers must demonstrate compliance with cGMP, possess robust Quality Control (QC) data, and provide comprehensive Certificates of Analysis (CoA). Regulatory agencies scrutinize API sources during inspections, emphasizing traceability and purity.

Regulatory Compliance:
Manufacturers sourcing API from different regions must verify adherence to the USP, EP, or other pharmacopeial standards. Additionally, dossier submissions often require supplier audits, validation reports, and stability data.

Pricing and Lead Times:
Asian suppliers tend to offer competitive pricing, but lead times and logistical considerations influence sourcing decisions. Diversifying suppliers mitigates supply disruption risks.

Environmental and Ethical Standards:
Suppliers committed to sustainable practices, reduced environmental impact, and ethical labor standards are increasingly preferred.

Supply Chain Resilience:
Given recent disruptions in global supply chains, establishing relationships with multiple qualified API suppliers mitigates risks associated with raw material shortages.

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Regulatory and Quality Challenges

The ophthalmic API market faces ongoing regulatory scrutiny, particularly around manufacturing practices, purity, and residual solvent levels. Suppliers need to stay aligned with evolving standards, including the ICH Q7 guidelines for APIs. Non-compliance risks cross-border market access and can delay commercialization of ACULAR LS.

Additionally, manufacturing supplements or changes in process must be appropriately validated and documented, especially when sourcing from third-party API suppliers. Any issues with API quality can directly impact the safety and efficacy of the finished ophthalmic product.

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Emerging Trends in API Sourcing

Digital Validation and Supply Chain Transparency:
Advanced digital tracking and blockchain technology are increasingly used for supply chain transparency, ensuring traceability from raw material procurement to final manufacturing.

Strategic Partnerships:
Forming long-term partnerships with API manufacturers enhances supply stability, facilitates technology transfer, and secures priority during capacity crunches.

Alternative Synthesis Methods:
Innovations in green chemistry and alternative synthesis pathways aim to reduce costs and environmental footprint. Suppliers adopting such methods may gain competitive advantages.

Regional Focus and Diversification:
Manufacturers and formulators are diversifying sources geographically to avoid over-reliance on specific regions, thereby reducing geopolitical and logistical risks.

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Conclusion

Sourcing high-quality ketorolac tromethamine API for ACULAR LS involves navigating a complex landscape of global suppliers, regulatory standards, and market dynamics. Established suppliers in North America and Europe, along with robust manufacturers in India and China, provide diverse options. Ensuring supply chain integrity, regulatory compliance, and consistent quality remains paramount for ophthalmic formulations.

Business professionals should prioritize establishing strong quality partnerships, verifying supplier certifications, and maintaining agility in sourcing strategies to mitigate risks and ensure uninterrupted supply of this critical API.

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Key Takeaways

• Authenticity and quality verification of ketorolac tromethamine API are essential for compliant ophthalmic products like ACULAR LS.
• Major API sourcing regions include North America, Europe, India, and China, each with distinct advantages concerning cost, capacity, and regulatory standards.
• Ongoing regulatory compliance, traceability, and environmental considerations influence supplier selection.
• Diversifying API sources reduces supply chain vulnerabilities amid disruptions.
• Technological advancements like digital tracking enhance transparency and supply chain security.

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FAQs

1. What are the primary factors to consider when sourcing API for ophthalmic drugs like ACULAR LS?
Quality compliance (cGMP certification, pharmacopeial standards), purity, regulatory adherence, supply stability, cost, and supplier reputation.

2. Are APIs from Asian manufacturers acceptable for FDA-regulated products?
Yes, provided they meet cGMP standards and demonstrate compliance with regulatory requirements, including rigorous testing and documentation.

3. How do suppliers ensure the purity of ketorolac tromethamine API?
Through validated synthesis processes, strict QC testing (impurity profiling, residual solvents), and adherence to pharmacopeial monographs.

4. Is regional diversification of API sources recommended?
Yes, it minimizes risks related to geopolitical issues, supply disruptions, and regulatory changes, ensuring a more resilient supply chain.

5. What regulatory documentation is essential when importing API for ophthalmic use?
Certificates of Analysis, Certificates of Origin, compliance declarations, and validation data demonstrating consistency with pharmacopeial standards.

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References

[1] United States Pharmacopeia (USP), Ketorolac Tromethamine Monograph.
[2] European Pharmacopoeia (EP), Ketorolac Tromethamine Monograph.
[3] Pharmaceutical Market Reports, Global API Market Overview, 2022.
[4] Regulatory Guidelines on API Manufacturing, FDA and EMA.
[5] Industry insights from API manufacturers and supply chain reports, 2022–2023.