altreno: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005-03	6 TUBE in 1 CARTON (0187-0005-03) / 3 g in 1 TUBE	2018-08-24
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005-10	10 TUBE in 1 CARTON (0187-0005-10) / 3 g in 1 TUBE (0187-0005-04)	2018-08-24
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005-20	1 TUBE in 1 CARTON (0187-0005-20) / 20 g in 1 TUBE	2018-08-24
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005-45	1 TUBE in 1 CARTON (0187-0005-45) / 45 g in 1 TUBE	2018-08-24
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005-50	1 BOTTLE, PUMP in 1 CARTON (0187-0005-50) / 50 g in 1 BOTTLE, PUMP	2018-08-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Altreno, a topical treatment primarily used for acne vulgaris, has garnered attention within dermatological and pharmaceutical sectors. Its active ingredient, trolamine salicylate, is delivered via a proprietary formulation offering targeted therapeutic effects with minimal systemic absorption. As demand for Altreno increases, understanding the landscape of suppliers—ranging from raw material providers to formulation manufacturers—is vital for stakeholders in supply chain management, pharmaceutical manufacturing, and procurement.

This analysis provides a comprehensive overview of the key suppliers involved in the production and distribution of Altreno, examining their roles, market positioning, and strategic significance. Maintaining a focus on the integrity of the supply chain, regulatory considerations, and emerging trends, we aim to equip industry professionals with actionable insights.

Overview of Altreno’s Composition and Manufacturing Process

Altreno (trolamine salicylate) is a topical, water-based gel formulated through a multi-step manufacturing process involving raw material synthesis, formulation, and filling. Trolamine salicylate itself is synthesized via esterification of salicylic acid with trolamine, necessitating high-quality raw materials and specialized chemical processing capabilities. The final formulation's stability, bioavailability, and efficacy hinge on sourcing premium raw components and precise manufacturing controls.

Key Suppliers for Raw Materials

1. Raw Material Suppliers: Trolamine and Salicylic Acid

a. Trolamine (Triethanolamine Salicylate Components)

Manufacturers and distributors:
- BASF: A global leader in specialty chemicals, BASF supplies high-grade triethanolamine, a critical raw material for synthesizing trolamine salicylate. Their extensive manufacturing facilities ensure consistent quality, regulatory compliance, and supply availability.
- Dow Chemical (now part of Dow Inc.): Provides triethanolamine formulations for pharmaceutical use, adhering to strict pharmacopeial standards.

b. Salicylic Acid

Major producers:
- Cabot Corporation: Offers pharmaceutical-grade salicylic acid, characterized by high purity levels suitable for medical applications.
- Eastman Chemical Company: Supplies high-quality salicylic acid with reliable supply chains and compliance to pharmaceutical standards.

Regulatory Considerations: Raw materials must meet USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other relevant pharmacopeial standards to ensure safety, efficacy, and regulatory approval.

2. Formulation and Manufacturing Equipment Suppliers

a. Formulation Equipment

Pharma-grade mixing tanks, homogenizers, and filling machinery are supplied by companies such as GEA Group and Bosch Packaging Technology, offering sterile and controlled-environment processing solutions critical for topical gel production.

b. Packaging Solutions

High-precision filling and packaging are supplied by firms like West Pharmaceutical Services and Harro Höfliger, specializing in pharmaceutical-grade tubes, pumps, and applicators that maintain product integrity.

Contract Manufacturing Organizations (CMOs) and Private Labelers

Given the specialized nature of Altreno’s formulation, several pharmaceutical contract manufacturing organizations are involved in scaling production and commercial distribution:

1. Specialty Pharmaceutical CMOs

CordenPharma: Operates dedicated facilities capable of small- and large-scale formulation of topical drugs, maintaining compliance with cGMP standards.
Recipharm: Offers formulation, fill-finish, and packaging services tailored for dermatological products, with significant capacity for gel-based formulations.
Alphapharm: Provides contract manufacturing services for topical medications, including gel formulations containing salicylates.

2. Strategic Partnerships and Licensing

Pharmaceutical companies often partner with established CMOs to streamline regulatory submissions and manufacturing, ensuring quality and supply stability for products like Altreno.

Distribution Channels and Global Suppliers

1. Distributors and Wholesalers

AmerisourceBergen, McKesson, and Cardinal Health serve as major distributors, sourcing Altreno directly from manufacturers or CMOs, ensuring nationwide and global distribution.

2. Regional Suppliers

In Europe, Vifor Pharma and regional distributors play roles in supplying regulated formulations, adhering to European Medicines Agency (EMA) standards.

3. Consideration of Supply Chain Risks

Dependence on specific raw material suppliers like BASF or Eastman entails risks of supply disruptions. Diversification and continuity planning are crucial, especially amid industry-wide supply chain challenges.

Regulatory and Quality Assurance Suppliers

Certifying Bodies and Testing Laboratories:
- Eurofins Scientific and SGS provide analytical testing, ensuring raw materials and finished products meet quality standards.
- Regulatory advisors assist in filing and maintaining compliance with FDA, EMA, and other global agencies.

Emerging Trends and Strategic Supply Chain Considerations

1. Focus on Sustainability and Raw Material Traceability

Increasing emphasis on sustainable sourcing and transparent supply chains influences supplier choices, with companies favoring environmentally responsible raw material producers.

2. Digital Supply Chain Integration

Adoption of blockchain and supply chain management software enhances traceability, reduces counterfeiting risks, and optimizes inventory.

3. Localized Manufacturing

Regional production facilities are emerging to mitigate geopolitical and logistical risks, promising faster turnaround times and compliance with local regulations.

Conclusion

The supply landscape for Altreno hinges on specialized raw material providers, contract manufacturers, and distribution channels ensuring product integrity and availability. Top raw material suppliers like BASF and Eastman Chemical are pivotal, alongside contract manufacturing and packaging specialists maintaining high standards. Strategic sourcing, risk mitigation, and compliance are critical components in maintaining an uninterrupted supply chain, especially amid global supply disruptions.

Key Takeaways

Raw Material Excellence: Ensuring consistent quality from suppliers such as BASF and Eastman underpins Altreno’s efficacy.
Strategic Partnerships: Collaborations with CMOs like CordenPharma and Recipharm facilitate scalable and compliant manufacturing.
Supply Chain Resilience: Diversifying raw material sources and regional manufacturing reduces risks.
Regulatory Compliance: Partnering with testing labs and certifying bodies ensures adherence to global standards.
Innovation and Sustainability: Embracing sustainable sourcing and digital traceability enhances supply chain robustness.

FAQs

1. Who are the primary raw material suppliers for trolamine salicylate used in Altreno?
Major suppliers include BASF and Eastman Chemical, providing pharmaceutical-grade triethanolamine and salicylic acid, respectively.

2. Are there regional differences in Altreno’s supply chain?
Yes. North American and European markets often rely on localized CMOs and distributors to meet regulatory and logistical requirements, ensuring faster access and compliance.

3. What are the main risks facing the Altreno supply chain?
Potential risks include raw material shortages, geopolitical disruptions, quality compliance issues, and manufacturing delays. Diversification and strategic partnerships mitigate these risks.

4. How does the formulation process influence supplier choices?
The precision and quality of formulation equipment suppliers like GEA and Bosch directly impact product stability and efficacy, making their technologies critical suppliers.

5. What trends are shaping future supply chain strategies for topical dermatological drugs like Altreno?
Sustainable sourcing, digital supply chain integration, regional manufacturing hubs, and advanced quality assurance practices are shaping future strategies.

References

[1] BASF Corporate Website. Raw Material Supplier for Triethanolamine.
[2] Eastman Chemical. Salicylic Acid Specifications for Pharmaceutical Use.
[3] GEA Group. Pharmaceutical Equipment for Topical Drug Formulation.
[4] CordenPharma. Contract Manufacturing Services for Dermatologicals.
[5] Industry Reports on Supply Chain Trends in Pharmaceuticals.

Suppliers and packagers for altreno

altreno

Suppliers for the Pharmaceutical Drug: Altreno