ACUVAIL: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

ACUVAIL (phenylephrine ophthalmic suspension 0.12%) is a prescription-only pharmaceutical used primarily as a postoperative miotic agent and topical vasoconstrictor in ophthalmology. Approved by the U.S. Food and Drug Administration (FDA) in 2016, ACUVAIL is formulated for the management of ocular hypertension and as an adjunct in cataract surgery. Its unique combination of phenylephrine and ketorolac addresses both pupil dilation and inflammation, making it a critical component in ophthalmic surgical protocols.

Given its specialized application, the supply chain for ACUVAIL is highly regulated, involving multiple layers including manufacturing, distribution, and regulatory compliance. The following analysis details the primary suppliers involved in the production and distribution of ACUVAIL, emphasizing the pharmaceutical manufacturers, importers, and distributors. This comprehensive overview aids industry stakeholders, healthcare providers, and potential investors in understanding the drug’s supply landscape.

Manufacturing and Origin of ACUVAIL

1. Manufacturer: Allergan (AbbVie Inc.)

The originator of ACUVAIL is Allergan, now part of AbbVie Inc. after their acquisition in 2020. Allergan, headquartered in Irvine, California, was the initial developer and marketer of ACUVAIL. The company's extensive portfolio of ophthalmic products positions it as a leading entity across the globe.

Manufacturing Facilities: Allergan produces ACUVAIL in FDA- and EU-approved manufacturing facilities, primarily located in the United States and Ireland. These facilities adhere to Good Manufacturing Practices (GMP), ensuring quality and safety standards as mandated by international regulatory authorities.
Supply Chain Considerations: Allergan maintains strict quality controls and rigorous supply chain standards to prevent shortages and ensure product integrity. Their manufacturing processes incorporate advanced technology and workflow automation, supporting large-scale production to meet global demand.

2. Contract Manufacturing Organizations (CMOs)

While Allergan owns the proprietary rights and controls most production aspects, they often collaborate with CMOs for certain components of manufacturing, packaging, or stabilization processes, especially given their global supply commitments.

Distribution Channels and Key Suppliers

1. Global Distributors and Wholesalers

Once manufactured, ACUVAIL enters a complex network of distribution, involving licensed pharmaceutical distributors, wholesale suppliers, and specialty ophthalmic distributors.

Major Distributors: Key distributors include McKesson, Cardinal Health, and AmerisourceBergen in the United States, which serve as primary supply conduits to hospitals, clinics, and pharmacies.
Specialty Distributors: For ophthalmic drugs, specialized distributors such as Akorn and Alcon (a Novartis subsidiary) are also involved. While ACUVAIL is a proprietary product of Allergan, Alcon distributes ophthalmic solutions and may carry similar products but not ACUVAIL specifically.

2. Regional and International Suppliers

European Markets: In Europe, suppliers such as STADA, Novartis, and local national distributors facilitate the supply of ACUVAIL, subject to regulatory approvals (e.g., EMA approval).
Emerging Markets: In developing regions, local pharmaceutical importers and licensed regional distributors handle the complexities of procurement, often relying on parallel imports or authorized representatives of Allergan.

3. Regulatory and Importation Partners

Licensed importers in specific countries handle the legal importation of ACUVAIL, ensuring compliance with local regulatory agencies such as the FDA (US), EMA (EU), and other national authorities.

Regulatory and Certification Aspects

The supply chain is regulated to ensure product safety and efficacy. Manufacturing sites are compliant with internationally recognized standards (GMP, ISO certifications). Furthermore:

FDA Approval: ACUVAIL’s approval by the FDA mandates stringent chemical, microbiological, and stability testing, with suppliers required to adhere to these quality parameters.
EUGMP Certification: European suppliers and manufacturers exporting ACUVAIL into EU countries possess EUGMP certification, verifying high manufacturing standards.
Batch Traceability: Supply chain participants utilize serialization and batch-tracking systems to prevent counterfeit drugs and maintain supply chain integrity.

Supply Chain Challenges

Supply chain disruption remains a concern, especially given the specialized nature of ophthalmic drugs:

Manufacturing Bottlenecks: Dependence on specific facilities and CMOs may cause delays during capacity constraints or regulatory inspections.
Global Logistics: Shipping restrictions, import/export tariffs, and geopolitical factors (e.g., trade tensions) can impact timely delivery.
Regulatory Compliance: Divergent regional regulations necessitate multiple certifications, complicating supply logistics.
Inventory Management: Hospitals and clinics often maintain cautious inventory levels due to shelf-life constraints and cost considerations, making stock shortages or surpluses critical issues.

Conclusion

The supply of ACUVAIL hinges on a tightly controlled manufacturing process led by Allergan/AbbVie, complemented by a network of regional and global distributors. Ensuring quality, regulatory compliance, and efficient logistics is vital to maintaining a steady supply of this ophthalmic drug. As the ophthalmic pharmaceutical landscape evolves, collaborations with CMOs, strategic regional partners, and advanced supply chain technologies will be essential for robust availability.

Key Takeaways

Primary Manufacturer: Allergan (now part of AbbVie Inc.) leads ACUVAIL’s production, ensuring GMP compliance and high-quality standards.
Distribution Network: Major US-based distributors like McKesson, Cardinal Health, and AmerisourceBergen serve as primary channels, complemented by regional suppliers globally.
Regulatory Compliance: Stringent adherence to FDA, EMA, and other international regulatory standards safeguards supply integrity.
Supply Challenges: Manufacturing bottlenecks and logistical disruptions pose risks to steady supply, necessitating proactive management.
Market Adaptation: Regional distributors and importers are crucial for maintaining availability in diverse markets, especially where regulatory pathways are complex.

FAQs

Q1: Who are the core manufacturers of ACUVAIL?
Allergan, now integrated into AbbVie Inc., is the primary manufacturer of ACUVAIL, operating GMP-certified facilities globally.

Q2: Which distributors supply ACUVAIL in North America?
Major distributors include McKesson, Cardinal Health, and AmerisourceBergen, which distribute to hospitals, clinics, and pharmacies.

Q3: How does regulatory compliance impact ACUVAIL’s supply?
Strict adherence to FDA, EMA, and other authorities ensures product safety and quality, with regulatory delays potentially impacting supply availability.

Q4: Are there regional differences in ACUVAIL suppliers?
Yes, European and other international markets rely on regional distributors and importers licensed to supply ACUVAIL, complying with local regulations.

Q5: What are common supply chain risks for ACUVAIL?
Manufacturing bottlenecks, logistical disruptions, geopolitical issues, and regulatory changes are the primary risks affecting supply continuity.

Sources:
[1] U.S. Food and Drug Administration (FDA). ACUVAIL approval details.
[2] AbbVie Corporate Website. Corporate overview and manufacturing info.
[3] Industry reports on ophthalmic pharmaceutical supply chains.

Suppliers and packagers for ACUVAIL

ACUVAIL

Suppliers for the Pharmaceutical Drug: ACUVAIL