ACANYA: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819	NDA	Bausch Health US, LLC	0187-3050-35	3.5 g in 1 TUBE (0187-3050-35)	2014-11-24
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819	NDA	Bausch Health US, LLC	0187-3050-50	1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP	2014-11-24
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819	NDA	Bausch Health US, LLC	13548-132-50	1 BOTTLE, PUMP in 1 CARTON (13548-132-50) / 50 g in 1 BOTTLE, PUMP	2010-07-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

ACANYA, a fixed-dose combination of tretinoin and benzoyl peroxide, is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. The drug is marketed by Almirall, S.A. and Bausch Health Companies Inc. in the United States. Analysis of its supply chain, particularly its active pharmaceutical ingredient (API) suppliers, is critical for assessing market stability, potential risks, and competitive positioning.

Who Supplies the Active Pharmaceutical Ingredients for ACANYA?

The primary active pharmaceutical ingredients (APIs) for ACANYA are tretinoin and benzoyl peroxide. Identifying the specific suppliers of these APIs is essential for understanding the security and diversification of ACANYA's manufacturing process. Publicly available information regarding direct API suppliers for specific branded drugs can be limited due to commercial confidentiality agreements. However, an analysis of pharmaceutical industry databases, patent filings, and common API manufacturing hubs provides insight into likely sources.

Tretinoin Suppliers

Tretinoin, a retinoid, is a well-established API with multiple manufacturers globally. Historically, China and India have been dominant in the production of tretinoin and its precursors.

Global Tretinoin Production Landscape: Companies in China, such as Zhejiang NHU Company Ltd. and Eastman Chemical Company (which acquired some former U.S. fine chemical businesses that were historically strong in retinoid synthesis), are significant producers. Indian manufacturers, including Abbott India Limited and Dr. Reddy's Laboratories, are also key players in the global tretinoin market. While specific contracts are not disclosed, it is highly probable that ACANYA sources its tretinoin from one or more of these established API manufacturers.
Patent Considerations: While the patents for tretinoin itself have long expired, manufacturing processes and polymorphs can be patented. Manufacturers may hold specific process patents that could influence sourcing decisions for pharmaceutical companies seeking to ensure freedom to operate.

Benzoyl Peroxide Suppliers

Benzoyl peroxide is another widely produced API used in numerous dermatological products. Like tretinoin, its manufacturing is concentrated in key regions.

Key Benzoyl Peroxide Manufacturers: Major global suppliers of benzoyl peroxide include companies like United Chemical Company (UCC), a significant player in the production of organic peroxides. Arkema Group is another large chemical manufacturer with a substantial portfolio in specialty chemicals, including benzoyl peroxide. These companies often supply to multiple pharmaceutical formulators worldwide.
Quality and Regulatory Compliance: Pharmaceutical grade benzoyl peroxide requires stringent quality control and compliance with Good Manufacturing Practices (GMP). Suppliers must meet the rigorous standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What Are the Key Manufacturing and Formulation Sites?

The formulation of ACANYA involves combining tretinoin and benzoyl peroxide into a topical gel. The manufacturing of the finished drug product typically occurs at specialized pharmaceutical facilities.

Almirall's Formulation Capabilities

Almirall, a partner in the commercialization of ACANYA, operates its own research and development centers and has manufacturing capabilities. While specific ACANYA formulation sites are not publicly detailed, Almirall has manufacturing facilities in Spain and potentially utilizes contract manufacturing organizations (CMOs) for its product lines.

Almirall Manufacturing Sites: Almirall has a significant manufacturing site in Sant Feliu de Llobregat, Barcelona, Spain. This facility is equipped for the production of various pharmaceutical dosage forms, including topical products.

Bausch Health's Role

Bausch Health Companies Inc. is responsible for the commercialization and distribution of ACANYA in the United States. This suggests they either have manufacturing agreements in place or utilize contract manufacturing organizations for the final product.

Bausch Health Manufacturing Network: Bausch Health has an extensive network of manufacturing facilities, including those specializing in dermatology products. For instance, their Dermik Laboratories division, acquired previously, was focused on dermatology. Bausch Health has manufacturing sites in Canada, the United States, and other global locations that could be involved in the production or packaging of ACANYA.
Contract Manufacturing Organizations (CMOs): The pharmaceutical industry frequently employs CMOs to handle drug product manufacturing. Companies like Catalent Pharma Solutions, Lonza Group, or Patheon (now part of Thermo Fisher Scientific) are major CMOs with the expertise and capacity for topical formulation and manufacturing. It is plausible that either Almirall or Bausch Health utilizes such CMOs for ACANYA production, particularly to leverage specialized expertise or scale capacity.

What Are the Regulatory and Quality Control Considerations?

The supply chain for ACANYA is subject to strict regulatory oversight to ensure product safety, efficacy, and quality.

FDA Oversight

The U.S. Food and Drug Administration (FDA) oversees the manufacturing and distribution of all pharmaceuticals sold in the United States, including ACANYA.

API Manufacturing Inspections: The FDA inspects API manufacturing facilities worldwide, regardless of location, if those APIs are intended for use in drugs marketed in the U.S. This includes facilities in China, India, and Europe.
Finished Product Inspections: The FDA also inspects facilities where the finished drug product (ACANYA gel) is formulated, filled, and packaged. This ensures compliance with current Good Manufacturing Practices (cGMP).
Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files (DMFs) to the FDA. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for an API. The drug product manufacturer (Almirall/Bausch Health) references the relevant DMF in their New Drug Application (NDA).

European Medicines Agency (EMA) Involvement

If ACANYA is marketed in Europe, the European Medicines Agency (EMA) and national competent authorities will have regulatory oversight.

European GMP Standards: Manufacturing facilities, including those producing APIs or finished products for the European market, must adhere to EU GMP guidelines.
Qualified Person (QP) Release: In the EU, each batch of finished product must be certified by a Qualified Person (QP) before it can be released for sale, ensuring compliance with manufacturing and quality standards.

Quality Control Protocols

Both API suppliers and finished product manufacturers must implement robust quality control systems.

Raw Material Testing: Incoming raw materials, including APIs, must be tested for identity, purity, and quality before use in manufacturing.
In-Process Controls: Manufacturing processes include in-process checks to monitor critical parameters and ensure consistency.
Finished Product Testing: The final ACANYA gel undergoes comprehensive testing for assay, purity, uniformity, dissolution (for topical release characteristics), and microbial limits.

What Are the Potential Supply Chain Risks and Mitigation Strategies?

The global nature of API sourcing and pharmaceutical manufacturing introduces several potential risks.

Geopolitical and Trade Risks

Dependence on Specific Regions: Over-reliance on APIs from a single country or region (e.g., China for certain APIs) can expose the supply chain to geopolitical tensions, trade disputes, or sudden export restrictions.
Mitigation: Diversifying API sourcing across multiple geographies and suppliers is a primary mitigation strategy. Establishing relationships with API manufacturers in different regions, including North America and Europe, can reduce this dependency.

Manufacturing Disruptions

Facility Issues: Unexpected events such as natural disasters, fires, equipment failures, or labor disputes at a key manufacturing site (either API or finished product) can lead to shortages.
Mitigation: Maintaining safety stock of APIs and finished products, qualifying secondary manufacturing sites, and having robust business continuity plans are essential. Dual sourcing for critical raw materials is also a key strategy.

Regulatory Changes

New Quality Standards: Evolving regulatory requirements for API purity, impurity profiling, or manufacturing processes can necessitate costly changes for suppliers and potentially impact the availability of certain APIs.
Mitigation: Close collaboration with API suppliers to stay abreast of regulatory changes and proactively adapt manufacturing processes is crucial. Ensuring suppliers have strong regulatory affairs departments is important.

Quality Control Failures

API or Product Recalls: Contamination, sub-potent ingredients, or packaging defects can lead to product recalls, disrupting supply and damaging brand reputation.
Mitigation: Rigorous supplier qualification programs, ongoing audits of manufacturing sites, and comprehensive in-house quality control testing are critical. Implementing strict change control management for all manufacturing processes is also vital.

Intellectual Property Risks

Patent Expirations: While ACANYA is a branded product, the underlying APIs may be off-patent, leading to generic competition. This does not directly impact the supply of the branded product's APIs but influences market dynamics and pricing pressures.
Process Patents: Manufacturers of APIs or the finished drug product may hold process patents. Infringement of these patents by competitors can lead to litigation and supply disruptions.
Mitigation: Thorough freedom-to-operate analyses and robust patent monitoring are necessary for both the drug product owner and its supply chain partners.

Conclusion

The supply chain for ACANYA involves a complex network of API manufacturers, formulators, and distributors. While specific supplier names are proprietary, it is evident that tretinoin and benzoyl peroxide are likely sourced from established global chemical and API manufacturers, with significant production capacity historically located in Asia and Europe. The formulation and packaging of the finished product are likely undertaken by Almirall and/or Bausch Health, or their designated contract manufacturing organizations, within facilities adhering to strict cGMP standards. Supply chain resilience depends on diversified sourcing, robust quality control, proactive regulatory compliance, and comprehensive risk management strategies.

Key Takeaways

ACANYA's APIs, tretinoin and benzoyl peroxide, are likely sourced from large-scale global manufacturers in China, India, and Europe.
Tretinoin production is dominated by companies like Zhejiang NHU Company Ltd. and Eastman Chemical Company, while benzoyl peroxide suppliers include United Chemical Company and Arkema Group.
Finished product formulation and packaging are likely handled by Almirall and/or Bausch Health, potentially utilizing contract manufacturing organizations.
Regulatory bodies such as the FDA and EMA enforce strict quality and manufacturing standards across the entire supply chain, from API production to finished product distribution.
Key supply chain risks include geopolitical instability, manufacturing disruptions, quality control failures, and regulatory changes, necessitating diversified sourcing and robust risk mitigation plans.

Frequently Asked Questions

Are there any known single-source APIs for ACANYA that pose a significant risk? Publicly disclosed information does not identify any single-source APIs for ACANYA. Pharmaceutical companies typically aim for dual or multiple sourcing for critical APIs to mitigate supply chain risks.
What are the typical lead times for sourcing APIs like tretinoin and benzoyl peroxide for a product like ACANYA? Lead times for APIs can vary but typically range from 3 to 9 months, depending on the complexity of synthesis, existing inventory, and the supplier's production schedule.
How does the patent status of tretinoin and benzoyl peroxide affect the supply chain for branded ACANYA? Since the patents for tretinoin and benzoyl peroxide have expired, their generic forms are widely available. This allows ACANYA to source these APIs from multiple competitive suppliers who manufacture them for various pharmaceutical applications, rather than being tied to a single patented source.
What is the regulatory pathway for a new API supplier to be qualified for ACANYA's manufacturing process? A new API supplier would need to undergo a rigorous qualification process including audits of their manufacturing facilities, review of their Drug Master File (DMF), demonstration of cGMP compliance, and successful batch testing of the API. The pharmaceutical company and regulatory authorities would vet the supplier extensively.
Are there any publicly available details on the specific contract manufacturing organizations (CMOs) used for ACANYA formulation? Specific CMOs engaged for ACANYA's formulation and packaging are generally not disclosed by the marketing companies (Almirall and Bausch Health) due to commercial confidentiality agreements.

Suppliers and packagers for ACANYA

ACANYA

ACANYA (Tretinoin and Benzoyl Peroxide) Drug Supply Chain Analysis