Suppliers and packagers for ATRALIN

ATRALIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070	NDA	Bausch Health US, LLC	13548-070-45	1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE	2007-07-26
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070	NDA AUTHORIZED GENERIC	Obagi Cosmeceuticals LLC	62032-413-20	20 g in 1 TUBE (62032-413-20)	2014-06-19
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-800-45	1 TUBE in 1 PACKAGE (68682-800-45) / 45 g in 1 TUBE	2007-07-26

Suppliers for the Pharmaceutical Drug: Atralin

Last updated: August 1, 2025

Introduction

Atralin (tretinoin gel 0.05%) is a topical medication primarily used for treating acne vulgaris. As a derivative of Vitamin A, tretinoin promotes cell turnover and prevents the formation of acne lesions. The pharmaceutical supply chain for Atralin involves manufacturers, raw material suppliers, distributors, and regulatory bodies ensuring the global availability of this skin treatment. Understanding the key suppliers involved in Atralin's production and distribution networks is critical for stakeholders seeking a resilient and compliant supply chain. This article explores the landscape of Atralin suppliers, focusing on primary manufacturers, raw ingredient suppliers, and distribution channels.

Atralin Manufacturing Landscape

1. Principal Manufacturers of Atralin

The original manufacturer of Atralin was GlaxoSmithKline (GSK), but the brand was acquired by Ortho Dermatologics, a division of Bausch Health. Currently, Bausch Health oversees the production and distribution of Atralin in many markets. The manufacturing process involves complex synthesis of tretinoin and strict quality-control standards to ensure product safety and efficacy.

Global pharmaceutical manufacturers producing dermatological gels with tretinoin may also serve as alternate or secondary suppliers for Atralin or similar formulations. Notable companies with capabilities in tretinoin formulation include:

• MARTINSREY (India): A contract manufacturer producing tretinoin-based topical formulations, supplying for various brands globally.

• LGM Pharma (USA): A supplier of pharmaceutical raw ingredients, including tretinoin, to manufacturers.

• Zhejiang Milestone Pharmaceutical (China): Produces tretinoin raw materials and finished dermatological products.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies utilize CMOs for manufacturing topical tretinoin products, which can include formulations akin to Atralin. These CMOs often operate under strict confidentiality agreements and adhere to Good Manufacturing Practices (GMP). Notable CMOs in dermatological product manufacturing include:

• Alcami Corporation: Provides contract manufacturing services for topical formulations.

• Patheon (now part of Thermo Fisher Scientific): Offers comprehensive CMO services for topical dermatological products.

Raw Material Suppliers for Tretinoin

1. Tretinoin Raw Material Suppliers

Tretinoin's supply chain begins with sourcing high-purity raw materials necessary for its synthesis. Several companies are involved in producing tretinoin bulk raw materials, including:

• Bulk Drug Suppliers in China and India: China-based Zhejiang Milestone Pharmaceutical and Indian firms like Lyophilization of India supply tretinoin raw materials to pharmaceutical manufacturers worldwide.

• LGM Pharma: Offers pharmaceutical-grade tretinoin suitable for topical formulations.

• GMP-certified Chinese Manufacturers: Such as Zhejiang Yamei Pharmaceutical, providing tretinoin raw materials compliant with global standards.

2. Quality and Regulatory Considerations

Raw material suppliers must adhere to stringent quality standards, including GMP certification and compliance with the US FDA, EMA, or other regulatory bodies. The purity of tretinoin (typically ≥98%) and the absence of impurities are critical factors impacting the final product's safety profile.

Distribution and Supply Chain Dynamics

1. Distribution Channels

Post-manufacture, Atralin is distributed through wholesalers, specialty pharmacies, and direct sales to dermatologists. Large pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen play a major role in ensuring product availability across the United States.

2. Import and Export Regulations

Given the controlled nature of tretinoin, regulatory oversight influences international trade. The importation of tretinoin raw materials and finished products must comply with national drug enforcement agencies' guidelines, including customs controls and documentation.

3. Market Competition and Alternatives

While Atralin remains a prominent brand, the market features competitive generic tretinoin formulations from various manufacturers, potentially affecting supply chain reliance on single sources. Generics often sourced from Indian and Chinese manufacturers bolster global supply but introduce variability in quality and regulatory compliance.

Supply Chain Challenges

• Regulatory Variability: Different jurisdictions impose diverse requirements, complicating cross-border supply chains.

• Raw Material Shortages: Political, logistical, or pandemic-driven disruptions can impair tretinoin raw material supplies.

• Quality Control: Ensuring consistent quality across raw materials and finished products remains paramount.

• Pricing Pressures: Competitive markets may exert downward pressure on procurement costs, impacting margins.

Emerging Trends

• Sustainability: Increased emphasis on sustainable sourcing and manufacturing practices.

• Supply Chain Digitalization: Adoption of blockchain and IoT to enhance traceability and transparency.

• Local Manufacturing: Countries aim to develop domestic production capabilities to reduce dependency on imports.

Key Takeaways

• Major players in Atralin manufacturing include Bausch Health and various contract manufacturers specializing in dermatological formulations.

• The supply chain for tretinoin raw materials is concentrated among Chinese and Indian manufacturers, emphasizing the importance of regulatory compliance and quality assurance.

• Distribution networks involve large pharmaceutical distributors, with logistics impacted by regulatory and geopolitical factors.

• Supply chain resilience hinges on diversified sourcing, quality assurance, and adherence to regulatory standards.

• Market competition from generic alternatives influences procurement strategies and supply stability.

FAQs

1. Who are the main manufacturers of Atralin?
Bausch Health, through its division Ortho Dermatologics, is the primary manufacturer. Contract manufacturers and generic producers also supply tretinoin topical formulations.

2. Where does the raw tretinoin ingredient primarily originate?
Major raw tretinoin supplies originate from Chinese companies like Zhejiang Milestone Pharmaceutical and Indian manufacturers such as Lyophilization of India.

3. Are there alternative suppliers for Atralin?
Yes, several generic formulations from different manufacturers exist, with some sourcing active ingredients from the same raw material suppliers.

4. How does regulations affect Atralin’s supply chain?
Strict adherence to GMP, FDA, and EMA standards ensures supply chain integrity. Regulatory disparities can impact import/export and manufacturing authorization.

5. What future trends could impact Atralin suppliers?
Enhanced digital supply chain technologies, increased regulatory scrutiny, and the shift towards sustainable sourcing are expected to influence supplier strategies.

Sources

1. [1] Bausch Health official website.
2. [2] GSK’s historical dermatology portfolio.
3. [3] LGM Pharma product catalog.
4. [4] Zhejiang Milestone Pharmaceutical company profile.
5. [5] Industry reports on tretinoin raw material sourcing and dermatology formulations.