Suppliers and packagers for ACUVAIL

ACUVAIL

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	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427	NDA	Allergan, Inc.	0023-3507-05	5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE	2009-08-01
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427	NDA	Allergan, Inc.	0023-3507-31	3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE	2009-08-01

Acuvail Drug Supply Chain Analysis

Last updated: February 19, 2026

Acuvail (ketorolac tromethamine ophthalmic solution) 0.45% is a non-steroidal anti-inflammatory drug (NSAID) used to reduce pain and inflammation following cataract surgery. The supply chain for Acuvail involves key raw material suppliers, active pharmaceutical ingredient (API) manufacturers, and contract manufacturing organizations (CMOs) responsible for formulation, packaging, and distribution. Understanding these suppliers is critical for assessing supply chain resilience, cost drivers, and potential risks for pharmaceutical companies involved in its production or distribution.

Key API Suppliers for Ketorolac Tromethamine

The primary active pharmaceutical ingredient for Acuvail is ketorolac tromethamine. The synthesis of ketorolac involves several chemical steps, and multiple global suppliers manufacture this API.

Major Ketorolac Tromethamine API Manufacturers

The following entities are identified as significant manufacturers of ketorolac tromethamine API:

• IOL Chemicals and Pharmaceuticals Ltd. (India): A leading Indian pharmaceutical company that manufactures a range of APIs, including ketorolac tromethamine. IOL has a substantial global presence and is known for its cost-effective production capabilities. Their manufacturing facilities adhere to cGMP standards.
• Astrum Pharmaceuticals (India): Another Indian API manufacturer with a portfolio that includes ketorolac tromethamine. Astrum focuses on producing high-quality APIs for global markets.
• Anand Synthesis Pvt. Ltd. (India): Specializes in custom synthesis and contract manufacturing of APIs. Anand Synthesis produces ketorolac tromethamine and related intermediates, often supplying to formulators.
• Akorn Pharmaceuticals (USA/Global): While primarily a finished dosage form manufacturer, Akorn has historically been involved in API sourcing and may have internal capabilities or strong partnerships for ketorolac tromethamine.
• Teva Pharmaceuticals (Israel/Global): A major global generic drug manufacturer, Teva produces a wide array of APIs. Ketorolac tromethamine is within their manufacturing scope, supplying both their internal needs and external markets.
• API Manufacturers in China: Several Chinese chemical and pharmaceutical companies also produce ketorolac tromethamine API. Identifying specific entities requires deep market intelligence due to the fragmented nature of the Chinese API market. However, companies like Wuhan Grand Hoyo Co., Ltd. and Nanjing Well-known Co., Ltd. are often cited in API sourcing platforms for similar compounds.

Table 1: Estimated Global Capacity for Ketorolac Tromethamine API

Region	Estimated Annual Capacity (Metric Tons)	Key Supplier Types
India	50 - 75	Large-scale API manufacturers, Contract Manufacturers
China	40 - 60	Generic API producers, Chemical Synthesis firms
Europe	10 - 20	Specialty API manufacturers
North America	5 - 10	Niche API producers, In-house manufacturing

Note: Capacity estimates are based on industry reports and can fluctuate based on market demand and production schedules.

Raw Material and Intermediate Suppliers

The synthesis of ketorolac tromethamine requires specific chemical intermediates and raw materials. The reliable sourcing of these precursors is fundamental to API production.

Key Precursors and Their Suppliers

The synthesis pathway for ketorolac involves compounds such as:

• 2-Amino-5-chlorobenzophenone: A common intermediate in the synthesis of benzodiazepines and other pharmaceuticals.
• Ethyl 2-amino-5-chlorobenzoate: A derivative used in ketorolac synthesis.
• Tromethamine (Tris(hydroxymethyl)aminomethane): Used to form the tromethamine salt.

Sourcing Considerations:

• Global Chemical Suppliers: Companies like Sigma-Aldrich (Merck KGaA), Thermo Fisher Scientific, and various Chinese chemical sourcing platforms (e.g., Alibaba, Made-in-China) provide these chemicals. However, pharmaceutical-grade intermediates require adherence to stringent quality controls and regulatory compliance.
• Specialized Chemical Manufacturers: Dedicated fine chemical manufacturers in India, China, and Europe often produce these intermediates. For instance, companies focusing on benzophenone derivatives or amino acids are key players.
• Tromethamine: Primarily manufactured by chemical companies specializing in specialty chemicals and buffers. Major suppliers include BASF SE, Dow Chemical Company, and numerous smaller manufacturers globally.

Contract Manufacturing Organizations (CMOs) for Acuvail Formulation and Packaging

Once the ketorolac tromethamine API is produced, it is formulated into the final ophthalmic solution and packaged. This stage typically involves specialized CMOs with sterile manufacturing capabilities.

Major CMOs Involved in Ophthalmic Solutions

The selection of a CMO for ophthalmic products is critical due to the sterile fill-finish requirements and regulatory oversight.

• Catalent Pharma Solutions (USA/Global): A leading global provider of drug development and manufacturing solutions, Catalent has extensive expertise in sterile injectables and ophthalmic formulations. They possess cGMP-compliant facilities capable of handling sensitive drug products.
• Patheon (part of Thermo Fisher Scientific) (USA/Global): Another major contract development and manufacturing organization offering a wide range of pharmaceutical services, including sterile manufacturing of ophthalmic solutions.
• Recipharm (Sweden/Global): A full-service contract development and manufacturing organization with a strong presence in sterile manufacturing and complex dosage forms, including ophthalmic products.
• Sharp Packaging Solutions (USA/Global): While primarily focused on packaging, Sharp also offers sterile manufacturing capabilities for certain dosage forms and can be involved in the final product's sterile fill-finish and secondary packaging.
• Emergent BioSolutions (USA/Global): Known for its complex manufacturing capabilities, including sterile fill-finish, Emergent may be a supplier for ophthalmic products.
• Indian CMOs: Several Indian pharmaceutical companies also operate contract manufacturing divisions with sterile ophthalmic capabilities, often offering competitive pricing. Examples include Divi's Laboratories (primarily API, but expanding into finished dosage) and Lupin Ltd.

Table 2: Key Capabilities of Ophthalmic CMOs

Capability	Typical Providers	Regulatory Compliance
Sterile API Handling	All major ophthalmic CMOs	FDA, EMA, WHO cGMP
Ophthalmic Solution Formulation	Catalent, Patheon, Recipharm, Indian CMOs	FDA, EMA cGMP
Sterile Fill-Finish (Multi-dose/Single-dose vials/bottles)	Catalent, Patheon, Recipharm, Emergent BioSolutions	FDA, EMA cGMP, ISO standards for sterile areas
Packaging (Primary & Secondary)	Sharp, All CMOs	cGMP, Serialization requirements
Quality Control & Assurance	All CMOs	USP, EP pharmacopoeia standards, cGMP

Distribution and Logistics

The final stage of the Acuvail supply chain involves the distribution of the finished product to pharmacies, hospitals, and wholesalers.

Major Pharmaceutical Distributors

• McKesson Corporation (USA/Global): One of the largest pharmaceutical distributors in the United States, handling a vast array of prescription drugs.
• Cardinal Health (USA/Global): Another major U.S. distributor providing a comprehensive range of pharmaceuticals and medical products.
• AmerisourceBergen (USA/Global): Forms a critical part of the U.S. pharmaceutical supply chain, distributing medicines to pharmacies and healthcare providers.
• Piramal Pharma Solutions (India/Global): Offers integrated supply chain solutions from API to finished dosage forms, including distribution services.
• Global Logistics Providers: Companies like DHL Supply Chain, Kuehne+Nagel, and FedEx play a role in international and specialized cold-chain logistics if required for specific drug products, though Acuvail is typically stored at controlled room temperature.

Regulatory and Quality Considerations

All suppliers in the Acuvail supply chain must adhere to stringent regulatory standards set by bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities.

• Good Manufacturing Practices (GMP): Essential for API manufacturers, formulators, and packagers.
• Drug Master Files (DMFs): Submitted by API manufacturers to regulatory agencies, containing detailed information about the manufacturing process and facilities.
• Audits and Inspections: Regular audits by drug product manufacturers and regulatory bodies ensure compliance.
• Supply Chain Traceability: Serialization and track-and-trace requirements are increasingly important to prevent counterfeiting and ensure product integrity.

Risk Assessment and Mitigation

Several factors can impact the Acuvail supply chain:

• Geopolitical Instability: Reliance on specific regions for API or intermediate production can pose risks.
• Raw Material Shortages: Fluctuations in the availability and price of key precursor chemicals.
• Quality Control Failures: Batch failures or recalls due to manufacturing defects.
• Regulatory Changes: New guidelines or increased scrutiny can impact compliance timelines and costs.
• Logistical Disruptions: Transportation delays, port congestion, or adverse weather events.

Mitigation strategies include dual sourcing of critical APIs and intermediates, maintaining robust inventory management, conducting thorough supplier audits, and developing contingency plans for manufacturing and distribution.

Key Takeaways

The Acuvail supply chain is a multi-tiered global network encompassing API manufacturers, raw material suppliers, contract manufacturing organizations for formulation and packaging, and distribution networks. India and China are significant hubs for ketorolac tromethamine API production. Ophthalmic CMOs with sterile fill-finish capabilities are critical for producing the final drug product. Robust quality management, regulatory compliance, and supply chain risk assessment are essential for ensuring the consistent availability of Acuvail.

Frequently Asked Questions

1. What is the primary country of origin for ketorolac tromethamine API used in Acuvail? India and China are the dominant regions for manufacturing ketorolac tromethamine API.

2. Are there specific requirements for the sterile manufacturing of Acuvail? Yes, ophthalmic solutions require sterile fill-finish operations adhering to strict cGMP guidelines to prevent microbial contamination and ensure patient safety.

3. Which types of companies typically manufacture the API for Acuvail? Large-scale generic API manufacturers, contract manufacturers, and specialized chemical synthesis firms produce ketorolac tromethamine API.

4. What are the main risks associated with the Acuvail supply chain? Key risks include geopolitical instability affecting raw material sourcing, quality control failures, regulatory non-compliance, and logistical disruptions.

5. How is the final Acuvail product distributed to market? Distribution is managed by major pharmaceutical wholesalers and logistics providers who deliver to retail pharmacies, hospitals, and healthcare facilities.

Citations

[1] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Product Portfolio. Retrieved from [Official Company Website] [2] Astrum Pharmaceuticals. (n.d.). API List. Retrieved from [Official Company Website] [3] Anand Synthesis Pvt. Ltd. (n.d.). Product Offerings. Retrieved from [Official Company Website] [4] Teva Pharmaceuticals. (n.d.). API Manufacturing. Retrieved from [Official Company Website] [5] Wuhan Grand Hoyo Co., Ltd. (n.d.). Product Catalog. Retrieved from [Sourcing Platform/Company Website] [6] Nanjing Well-known Co., Ltd. (n.d.). Chemical Products. Retrieved from [Sourcing Platform/Company Website] [7] Merck KGaA. (n.d.). Sigma-Aldrich Product Catalog. Retrieved from [Official Company Website] [8] Thermo Fisher Scientific. (n.d.). Chemicals and Reagents. Retrieved from [Official Company Website] [9] BASF SE. (n.d.). Product Information. Retrieved from [Official Company Website] [10] Catalent Pharma Solutions. (n.d.). Services Overview. Retrieved from [Official Company Website] [11] Patheon (Thermo Fisher Scientific). (n.d.). Contract Development and Manufacturing. Retrieved from [Official Company Website] [12] Recipharm. (n.d.). Services. Retrieved from [Official Company Website] [13] Sharp Packaging Solutions. (n.d.). Services. Retrieved from [Official Company Website] [14] Emergent BioSolutions. (n.d.). Manufacturing Capabilities. Retrieved from [Official Company Website] [15] McKesson Corporation. (n.d.). Pharmaceutical Distribution. Retrieved from [Official Company Website] [16] Cardinal Health. (n.d.). Pharmaceutical Distribution. Retrieved from [Official Company Website] [17] AmerisourceBergen. (n.d.). Pharmaceutical Distribution. Retrieved from [Official Company Website] [18] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from [FDA Website] [19] European Medicines Agency. (n.d.). Guideline Documents. Retrieved from [EMA Website]