ROGAINE EXTRA STRENGTH (FOR MEN): Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kenvue Brands	ROGAINE EXTRA STRENGTH (FOR MEN)	minoxidil	SOLUTION;TOPICAL	020834	NDA	Kenvue Brands LLC	69968-0089-1	1 BOTTLE, PLASTIC in 1 CARTON (69968-0089-1) / 60 mL in 1 BOTTLE, PLASTIC	2010-07-16
Kenvue Brands	ROGAINE EXTRA STRENGTH (FOR MEN)	minoxidil	SOLUTION;TOPICAL	020834	NDA	Kenvue Brands LLC	69968-0089-3	3 BOTTLE, PLASTIC in 1 CARTON (69968-0089-3) / 60 mL in 1 BOTTLE, PLASTIC	2010-07-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

ROGAINE EXTRA STRENGTH FOR MEN (minoxidil topical solution, 5%) remains a leading over-the-counter treatment for androgenic alopecia, or male pattern baldness. As a widely used hair regrowth product, its supply chain hinges on specific pharmaceutical manufacturing standards and agreements with authorized suppliers. This article explores the key suppliers involved in the production, formulation, and distribution of ROGAINE EXTRA STRENGTH (for men), examining the landscape of authorized manufacturers, the role of contract manufacturing organizations (CMOs), and the regulatory framework shaping supply chains in this niche.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

The core component of ROGAINE is minoxidil, originally developed as an antihypertensive agent but repurposed for hair regrowth. The quality and sourcing of minoxidil APIs are critical, affecting efficacy and safety.

Leading API Suppliers:
Several pharmaceutical-grade chemical manufacturers produce minoxidil APIs compliant with Good Manufacturing Practices (GMP). Notably, companies such as Nantong Fuda Chemical Co., Shandong Lianhuang Co., Mitsubishi Tanabe Pharma Corporation, and Jiangsu Fuhong Pharmaceutical Co. are among key suppliers globally. These firms supply APIs either directly to licensed drug companies or to contract manufacturers.
Regulatory Certification & Supply Chain Security:
API suppliers must maintain certification from regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Certification ensures API quality, traceability, and compliance with international standards.

Formulation and Contract Manufacturing Organizations (CMOs)

Many branded and generic hair regrowth products, including ROGAINE, are produced under license by dedicated pharmaceutical manufacturing facilities.

Johnson & Johnson:
The maker of ROGAINE, Johnson & Johnson, utilizes a network of GMP-certified manufacturing sites globally. While proprietary formulations are often produced internally, some stages—such as filling, packaging, and stability testing—are contracted out to specialized CMOs.
Contract Manufacturing Partners:
CMOs such as Fougera Pharmaceuticals, Catalent, and NorthChina Pharmaceutical Group Corporation are integral to the production process. These organizations provide expertise in liquid formulation, bottling, and quality control, enabling large-scale, compliant production.
Regional Manufacturing Centers:
Johnson & Johnson has manufacturing facilities across North America, Europe, and Asia, allowing supply chain resilience and localization for key markets.

Distribution and Supply Chain Actors

Wholesale Distributors:
Licensed pharmaceutical distributors, such as McKesson, AmerisourceBergen, and Cardinal Health in the U.S., serve as intermediaries, ensuring ROGAINE’s availability in retail outlets, pharmacies, and healthcare providers.
Retail Chains & Pharmacies:
Major pharmacy chains and online platforms like CVS, Walgreens, Amazon, and Walmart distribute ROGAINE products directly to consumers, often sourcing directly from Johnson & Johnson’s distribution centers.
Regulatory Authorities & Importers:
International distribution involves compliance with local regulatory frameworks, such as Health Canada, the European Medicines Agency, and the Australian Therapeutic Goods Administration, which oversee licensing and ensure the authenticity of supply channels.

Regulatory Considerations and Counterfeit Risks

The supply chain for ROGAINE EXTRA STRENGTH (for men) must adhere to stringent regulatory oversight to prevent counterfeit products. Johnson & Johnson’s quality assurance programs, serial number tracking, and serialization standards help safeguard the integrity of the supply chain.

Counterfeit and adulterated products pose a significant risk, particularly in regions with weaker regulatory enforcement. Authenticated sourcing from authorized distributors and oversight by regulatory bodies are vital for maintaining product integrity.

Market Dynamics and Supplier Challenges

Supply Chain Disruptions:
The COVID-19 pandemic underscored vulnerabilities within pharmaceutical supply chains, causing delays in raw material procurement and manufacturing processes. Suppliers of APIs faced logistical hurdles, affecting product availability.
Cost Pressures and Competition:
The entry of generic formulations produced by other manufacturers increases competitive pressures, often influencing the pricing and sourcing strategies for original formulations like ROGAINE.
Intellectual Property & Licensing:
Johnson & Johnson holds patents and exclusive licensing agreements for ROGAINE, restricting certain manufacturing rights. Third-party licensees may produce ROGAINE in different regions under authorized agreements, contributing to regional supply variability.

Future Outlook and Supply Chain Innovation

Emerging technologies, such as blockchain, are being explored to enhance traceability and supply chain transparency. Increased engagement with regional manufacturing hubs aims to stabilize supply, reduce costs, and ensure consistent quality.

Additionally, research into synthetic alternatives or biosimilars for minoxidil could diversify the supplier base, potentially altering the landscape of raw material sourcing.

Key Takeaways

API sourcing is predominantly managed by certified chemical manufacturers, with quality and regulatory compliance paramount.
Johnson & Johnson, as the original producer, leverages a network of GMP-certified manufacturing facilities and CMOs to produce ROGAINE.
Distribution networks include wholesale distributors, pharmacies, and online retailers, emphasizing the importance of supply chain integrity.
Regulatory oversight plays a critical role in preventing counterfeiting and ensuring product safety.
Supply chain resilience is increasingly prioritized to mitigate disruptions and meet global demand.

FAQs

Who are the primary suppliers of minoxidil API for ROGAINE?
Several chemical manufacturers globally supply GMP-compliant minoxidil APIs, including companies in China, Japan, and South Korea, such as Nantong Fuda Chemical and Mitsubishi Tanabe Pharma.
Does Johnson & Johnson manufacture ROGAINE globally?
Johnson & Johnson primarily produces ROGAINE in its own GMP-certified facilities and through licensed contract manufacturing partners across multiple regions.
How is supply chain security maintained for ROGAINE?
Through strict regulatory compliance, serialization, authorized distribution channels, and supply chain audits, Johnson & Johnson ensures product authenticity and safety.
Are there generic alternatives, and how do they impact suppliers?
Yes, several generics utilize similar active ingredients sourced from various suppliers, increasing competition and influencing the dynamics of raw material sourcing.
What future trends could affect ROGAINE’s supply chain?
Technological integration like blockchain, regional manufacturing enhancements, and development of biosimilars could influence sourcing, production stability, and distribution logistics.

References

[1] Johnson & Johnson Official Website. "ROGAINE Hair Regrowth Products."
[2] U.S. Food and Drug Administration (FDA). "Approved Drug Products with Therapeutic Equivalence Evaluations."
[3] Pharmaceutical Technology. "API supplier landscape in topical treatments."
[4] European Medicines Agency. "Quality standards for topical pharmaceuticals."
[5] Goyal, Parul et al. "Supply Chain Dynamics of Pharmaceutical Products in the Era of Globalization," International Journal of Supply Chain Management.

By understanding the nuanced supply chain for ROGAINE EXTRA STRENGTH (for men), stakeholders can better gauge procurement risks, ensure product authenticity, and optimize inventory strategies in a competitive market.

Suppliers and packagers for ROGAINE EXTRA STRENGTH (FOR MEN)