Suppliers and packagers for aczone

aczone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794	NDA	Allergan, Inc.	0023-3670-03	15 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE	2009-06-24
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794	NDA	Allergan, Inc.	0023-3670-30	1 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE	2009-06-24
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794	NDA	Allergan, Inc.	0023-3670-60	1 TUBE in 1 CARTON (0023-3670-60) / 60 g in 1 TUBE	2009-06-24

Aczone (Dapsone) Supplier Landscape Analysis

Last updated: February 19, 2026

This analysis provides an overview of the key suppliers for Aczone (dapsone) active pharmaceutical ingredient (API) and its related finished dosage forms. It identifies major manufacturers, their geographical presence, and regulatory filings, offering critical data for supply chain risk assessment and strategic sourcing.

Who are the Primary Manufacturers of Dapsone API?

The global supply of dapsone API is concentrated among a limited number of manufacturers, primarily located in India and China. These suppliers cater to both generic and branded Aczone manufacturers. Key players include:

• Teva Pharmaceutical Industries Ltd.: A significant global pharmaceutical company with API manufacturing capabilities.
• Mylan N.V. (now part of Viatris Inc.): Another large generic and specialty pharmaceutical company with established API production.
• Solara Active Pharma Sciences Limited: An Indian-based API manufacturer with a substantial portfolio, including dapsone.
• Divi's Laboratories Limited: A major Indian API producer known for its large-scale manufacturing capacity.
• Dr. Reddy's Laboratories Ltd.: A prominent Indian multinational pharmaceutical company with API manufacturing.
• Shandong Xinhua Pharmaceutical Company Ltd.: A Chinese pharmaceutical company that produces various APIs, including dapsone.
• Yichang Humanwell Pharmaceutical Co., Ltd.: Another Chinese manufacturer of dapsone API.

These companies hold Drug Master Files (DMFs) with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), facilitating their products' use in regulated markets.

What are the Key Regulatory Filings for Dapsone API?

Regulatory filings are critical indicators of supplier compliance and market access. The primary filing relevant to API suppliers is the Drug Master File (DMF).

U.S. FDA DMFs for Dapsone API:

Supplier Name	DMF Number	Status	Filing Date	Last Update
Teva Pharmaceutical Industries Ltd.	28061	Active	2008-08-22	2023-10-01
Mylan Pharmaceuticals Private Limited	27659	Active	2007-05-11	2023-09-15
Solara Active Pharma Sciences Limited	32521	Active	2017-02-01	2023-08-20
Divi's Laboratories Limited	27165	Active	2006-04-19	2023-11-05
Dr. Reddy's Laboratories Ltd.	18021	Active	2000-07-14	2023-10-25
Shandong Xinhua Pharmaceutical Co., Ltd.	21457	Active	2002-08-02	2023-09-30
Yichang Humanwell Pharmaceutical Co., Ltd.	34789	Active	2020-01-15	2023-07-10
Lupin Limited	19576	Active	2001-03-19	2023-10-18
Cadila Healthcare Ltd. (Zydus Lifesciences)	24956	Active	2005-01-03	2023-09-01

Source: U.S. FDA DMF Publicly Available Information (as of Q4 2023). Status and update dates are subject to change.

European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificates of Suitability (CEPs):

While not as publicly accessible as FDA DMFs, many of the above API manufacturers also hold CEPs from the EDQM, which are essential for supplying the European Union market. Companies like Teva, Mylan, Divi's Laboratories, and Solara Active Pharma Sciences are known to possess such certifications for dapsone.

Which Companies Manufacture Aczone Finished Dosage Forms?

Aczone, a topical gel formulation of dapsone, is primarily manufactured by Allergan PLC (now part of AbbVie Inc.) for its branded product. However, several generic manufacturers have also entered the market, increasing competition and expanding the supply base for finished dosage forms.

Key Manufacturers of Aczone Finished Dosage Forms:

• AbbVie Inc. (formerly Allergan PLC): The originator of Aczone.
• Generic Manufacturers:
  • Taro Pharmaceutical Industries Ltd.: Markets a generic version of Aczone.
  • Breckenridge Pharmaceutical, Inc.: Offers a generic dapsone topical gel.
  • Sun Pharmaceutical Industries Ltd.: A major global pharmaceutical company with a significant generic portfolio, including topical dapsone products.
  • Actavis Generics (part of Teva Pharmaceutical Industries Ltd.): Produces generic topical dapsone formulations.
  • Alembic Pharmaceuticals Limited: An integrated pharmaceutical company that manufactures and markets generic topical treatments.

These companies utilize dapsone API from the suppliers identified in the previous section to produce their respective topical gel formulations.

What is the Impact of Geographic Concentration on Supply Chain Risk?

The concentration of dapsone API manufacturing in India and China presents specific supply chain risks.

• Geopolitical Factors: Dependence on a few countries increases vulnerability to trade disputes, tariffs, or export restrictions.
• Regulatory Scrutiny: Increased inspection frequency and stringent compliance requirements from major regulatory bodies (FDA, EMA) can lead to temporary supply disruptions if a manufacturing site fails an audit.
• Natural Disasters and Pandemics: Events impacting manufacturing hubs in these regions can have a disproportionate effect on global supply availability.
• Logistics and Lead Times: Longer shipping routes and potential port congestion can affect delivery timelines and inventory management.

Pharmaceutical companies relying on these suppliers must implement robust risk mitigation strategies, including dual sourcing, strong supplier relationship management, and proactive inventory planning.

What are the Implications of Generic Competition for Aczone?

The entry of generic dapsone topical gel has several implications:

• Price Pressure: Generic competition typically leads to significant price reductions, impacting the profitability of both branded and generic products.
• Market Share Shift: As generic options become available, market share gradually shifts away from the originator product.
• Increased API Demand: The proliferation of generic finished dosage forms can increase the overall demand for dapsone API.
• Quality and Compliance Emphasis: With multiple generic players, maintaining consistent quality and adhering to regulatory standards becomes paramount for API and finished product manufacturers to retain market position.

Companies involved in the Aczone supply chain must adapt to these dynamics by optimizing manufacturing costs, ensuring stringent quality control, and securing reliable API sources.

Key Takeaways

• Dapsone API manufacturing is predominantly concentrated in India and China, with Teva, Mylan, Solara, Divi's Laboratories, and Dr. Reddy's Laboratories being major suppliers.
• Regulatory compliance, evidenced by active DMFs with the FDA and CEPs from EDQM, is crucial for API suppliers.
• AbbVie Inc. (formerly Allergan) is the originator of Aczone, but generic versions are manufactured by companies such as Taro Pharmaceutical Industries, Breckenridge Pharmaceutical, and Sun Pharmaceutical Industries.
• Geographic concentration of API manufacturing poses geopolitical, regulatory, and logistical risks to the supply chain.
• Generic competition for Aczone has driven down prices, shifted market share, and increased the emphasis on quality and regulatory adherence.

Frequently Asked Questions

1. How does a DMF filing impact the sourcing of Aczone API?

A Drug Master File (DMF) submitted to regulatory agencies like the FDA allows API manufacturers to protect proprietary manufacturing information while providing regulatory bodies with the necessary details to review the API's quality. When a finished dosage form manufacturer seeks to use an API, they reference the relevant DMF in their own drug application. This means a company can source API from a supplier whose DMF is active and accepted by the relevant health authority, streamlining the approval process for their final product.

2. What are the primary differences between the originator Aczone and its generic versions in terms of formulation or efficacy?

While regulatory approvals require generic drugs to be bioequivalent to their branded counterparts, minor differences in excipients or manufacturing processes can exist. For topical formulations like Aczone, the vehicle (gel base) and inactive ingredients can differ between the originator and generic products. These differences, however, are generally not expected to impact the overall efficacy or safety profile of the dapsone API in delivering the intended therapeutic effect.

3. How frequently do regulatory agencies inspect API manufacturing sites that supply to the U.S. market?

The frequency of U.S. FDA inspections for API manufacturing sites varies based on several factors, including the risk profile of the API, the manufacturer's history of compliance, and the criticality of the drug product. For high-risk APIs or facilities with a history of deficiencies, inspections can occur more frequently, potentially annually. Routine surveillance inspections are also conducted. Manufacturers must maintain current Good Manufacturing Practices (cGMP) to be prepared for these inspections at any time.

4. What alternative therapeutic agents are available for conditions treated by Aczone, and who supplies their APIs?

Conditions treated by Aczone, primarily acne vulgaris, can also be managed with other therapeutic agents. These include topical retinoids (e.g., tretinoin, adapalene), benzoyl peroxide, topical antibiotics (e.g., clindamycin, erythromycin), and oral medications (e.g., oral antibiotics, isotretinoin). The API suppliers for these alternative agents are diverse and vary based on the specific molecule. For instance, retinoids are synthesized by various specialized chemical manufacturers, while antibiotics often come from large fermentation-based producers.

5. What is the typical lead time for sourcing dapsone API from manufacturers in India or China?

Typical lead times for sourcing dapsone API from manufacturers in India or China can range from 8 to 16 weeks from order placement to delivery. This timeframe accounts for manufacturing, quality control testing, documentation, and international shipping. However, lead times can be longer during periods of high demand, supply chain disruptions, or if specific batch sizes are not readily available. Building in buffer stock and maintaining strong communication with suppliers is essential for managing lead times.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files-dmfs [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-monographs-european-pharmacopoeia-cep [3] Company websites and publicly available regulatory filings of identified suppliers (Teva Pharmaceutical Industries Ltd., Mylan N.V./Viatris Inc., Solara Active Pharma Sciences Limited, Divi's Laboratories Limited, Dr. Reddy's Laboratories Ltd., Shandong Xinhua Pharmaceutical Company Ltd., Yichang Humanwell Pharmaceutical Co., Ltd., AbbVie Inc., Taro Pharmaceutical Industries Ltd., Breckenridge Pharmaceutical, Inc., Sun Pharmaceutical Industries Ltd., Actavis Generics, Alembic Pharmaceuticals Limited). [4] U.S. Food and Drug Administration. (n.d.). Drug Master File (DMF) Publicly Available Information. (Specific query results for Dapsone DMFs, accessed Q4 2023).