Suppliers and packagers for retin-a

retin-a

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA	Bausch Health US, LLC	0187-5160-20	1 TUBE in 1 CARTON (0187-5160-20) / 20 g in 1 TUBE	1988-10-30
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA	Bausch Health US, LLC	0187-5160-45	1 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE	1988-10-30
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-8082-20	1 TUBE in 1 CARTON (0378-8082-20) / 20 g in 1 TUBE	2019-04-03
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-8082-45	1 TUBE in 1 CARTON (0378-8082-45) / 45 g in 1 TUBE	2019-04-03

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Retin-A

Introduction
Retin-A, the popular topical formulation of tretinoin, is globally recognized for its efficacy in treating acne vulgaris, photoaging, and other dermatological conditions. As a critically valued cosmetic and medical product, Retin-A’s supply chain involves a complex network of manufacturers, authorized distributors, and regulatory authorities. This article offers a detailed analysis of the key suppliers of Retin-A, including manufacturing companies, authorized distributors, and the implications of supply dynamics for stakeholders.

Manufacturers of Retin-A (Tretinoin)

Retin-A’s active pharmaceutical ingredient (API), tretinoin, is produced by a limited number of specialized chemical and pharmaceutical manufacturers, primarily within regulated markets. The original patent holder, Ortho Pharmaceutical (a division of Johnson & Johnson), developed Retin-A in the 1970s, but the drug’s patent expiry allowed multiple generic manufacturers to enter the market.

Key API Suppliers

1. Janssen Pharmaceuticals / Johnson & Johnson
   Although the original patent has expired, Johnson & Johnson's Janssen division historically played a pivotal role in the initial manufacturing and distribution of Retin-A. Currently, the company focuses more on branded formulations, but it retains manufacturing capacity and licensing agreements for tretinoin (source: Johnson & Johnson official reports).

2. Mitsubishi Tanabe Pharma Corporation
   A major Japanese pharmaceutical company, Mitsubishi Tanabe produces tretinoin for unmet medical needs, including formulations similar to Retin-A (source: Mitsubishi Tanabe Pharma’s product portfolio). Their involvement extends to supplying high-purity tretinoin for both branded and generic products globally.

3. Sicor, now part of Teva Pharmaceuticals
   Sicor was a key API producer with a long history of manufacturing tretinoin before its acquisition by Teva. Teva continues to supply tretinoin API to generic Retin-A manufacturers worldwide, leveraging cost-effective manufacturing facilities in India and Israel (source: Teva Annual Reports).

4. Dr. Reddy’s Laboratories
   A leading Indian pharmaceutical company, Dr. Reddy’s produces tretinoin API used in generic Retin-A formulations. They source high-grade raw materials and possess manufacturing facilities compliant with international standards (source: Dr. Reddy’s corporate disclosures).

5. Mylan / Viatris
   Mylan, now part of Viatris, supplies tretinoin to various generic dermatological products, including Retin-A derivatives. Their extensive API manufacturing network supports global supply chains.

Distribution and Authorized Suppliers

While API manufacturing is concentrated among limited firms, the distribution of Retin-A formulations involves a broader network. Only licensed pharmacies and authorized distributors in regulated markets are permitted to sell Retin-A directly, ensuring quality standards and compliance.

Licensed Distributors & Pharmacies

• Pfizer and Teva act as key licensed distributors for branded and generic formulations in various markets.
• Authorized Dermatology Clinics and Specialty Pharmacies often serve as procurement points, particularly in the United States and Europe.

Supply Chain Dynamics and Regulatory Influence

The supply of Retin-A has been relatively stable, but recent years have seen increased regulatory scrutiny and supply chain disruptions, especially amid global manufacturing challenges and regulatory tightenings.

1. Patent expirations globally increased the number of generic suppliers but also prompted quality assurance considerations.
2. Regulatory audits by agencies such as the FDA and EMA impact manufacturing continuity, especially for smaller API producers.
3. Raw material shortages and production delays occasionally disrupt retinoin supply, affecting both API and finished product availability.

Key Players and Competitive Landscape

Despite a consolidated API production base, the competitive landscape of Retin-A formulations relies on licensing agreements, geographic market access, and quality assurance. Major pharmaceutical companies—Johnson & Johnson, Teva, Mylan, and Dr. Reddy’s—dominate the supply scene, with significant market shares in North America, Europe, and Asia.

Emerging Suppliers and Market Trends

• Chinese and Indian API Producers: Increased manufacturing capacity in these regions has expanded the global supply, sometimes leading to concerns over quality control and regulatory compliance (source: WHO reports).
• Bioequivalent and Alternative Tretinoin Formulations: Innovators explore novel delivery methods, which may influence traditional suppliers' market shares.

Regulatory and Patent Landscape

The patent expiration of Retin-A has facilitated global generic production, but brand-name formulations remain protected in certain markets for specific formulations or delivery systems. Regulatory approvals, such as those by the FDA and EMA, are essential for market entry.

Conclusion
The supply chain of Retin-A is underpinned by a handful of API manufacturers, primarily in Japan, India, and Israel, with major pharmaceutical players like Johnson & Johnson, Teva, and Dr. Reddy’s leading the way. Distribution is tightly controlled, balancing market access with regulatory compliance. Supply stability remains generally strong, but geopolitical factors, regulatory audits, and raw material shortages could influence future availability. For stakeholders—whether healthcare providers, pharmacists, or investors—monitoring API production capacity, regulatory developments, and market entry barriers is critical to maintaining supply continuity.

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Key Takeaways

• The global API supply for tretinoin is concentrated among major pharmaceutical firms, with India and Israel being significant manufacturing hubs.
• Patent expirations and regulatory standards have enabled a competitive generic market, providing diverse supply sources for Retin-A formulations.
• Supply chain disruptions, raw material constraints, and regulatory actions remain risks to the consistent availability of Retin-A.
• Stakeholders should pay close attention to API producer compliance and regional market regulations to mitigate potential shortages.
• Emerging players in Asia are expanding API capacity, possibly influencing global pricing and supply stability.

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Frequently Asked Questions (FAQs)

1. Who are the primary manufacturers of tretinoin API used in Retin-A?
The leading API manufacturers include Mitsubishi Tanabe Pharma, Teva Pharmaceuticals (via Sicor), Dr. Reddy’s Laboratories, and historically Johnson & Johnson. These firms supply tretinoin to various markets globally.

2. Are generic versions of Retin-A chemically identical to the original?
Yes. Generics contain the same active ingredient, tretinoin, in equivalent dosages and formulations, meeting rigorous regulatory standards for bioequivalence and safety.

3. How does patent expiration affect the supply of Retin-A?
Patent expiration has facilitated increased manufacturing by generic firms, broadening supply sources but also emphasizing the importance of quality and regulatory oversight.

4. What factors could disrupt the supply of Retin-A in the future?
Potential disruptions include raw material shortages, manufacturing plant regulatory issues, geopolitical tensions, and supply chain interruptions exacerbated by global events.

5. Can new API suppliers enter the Retin-A market easily?
Entry depends on compliance with Good Manufacturing Practices (GMP), regulatory approvals, and establishing reliable production capacity—barriers that are significant but gradually lowering with technological advancements and emerging regional manufacturers.

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Sources
[1] Johnson & Johnson Annual Report, 2022.
[2] Mitsubishi Tanabe Pharma Official Website.
[3] Teva Pharmaceuticals Annual Report, 2022.
[4] Dr. Reddy’s Laboratories Corporate Disclosure, 2022.
[5] WHO Report on Pharmaceutical Raw Material Markets, 2021.