zonalon: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-8117-45	1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBE	2019-01-04
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126	NDA	Mylan Pharmaceuticals Inc.	0378-8123-30	1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE	2018-11-14
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126	NDA	Mylan Pharmaceuticals Inc.	0378-8123-45	1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE	2018-11-14
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126	NDA	Mylan Pharmaceuticals Inc.	0378-8130-45	1 TUBE in 1 CARTON (0378-8130-45) / 45 g in 1 TUBE	2018-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Zonalon, a pharmaceutical compound, has garnered attention within the healthcare industry for its therapeutic applications, particularly in dermatological and related treatments. As with any pharmaceutical agent, the availability and distribution of Zonalon hinge on a well-established supply chain, involving multiple suppliers—manufacturers, distributors, and authorized vendors. This article provides a comprehensive overview of current suppliers for Zonalon, analyzing their roles, market position, regulatory compliance, and geographical reach to inform business and healthcare decisions.

Understanding Zonalon's Market and Supply Ecosystem

Zonalon's Composition and Therapeutic Use

While specific molecular details and indications for Zonalon are proprietary or not disclosed publicly, it is often utilized in specialized treatments, often in dermatology, owing to its unique pharmacological action. The complexity of its formulation and regulatory status influences the number and types of suppliers authorized to distribute it.

Regulatory Status and Approval

Zonalon's supply is governed by national regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and their counterparts worldwide. Manufacturers and suppliers must hold proper approvals, such as a New Drug Application (NDA) or Marketing Authorization, ensuring safety, efficacy, and quality compliance.

Major Suppliers and Manufacturers of Zonalon

1. Primary Manufacturers

The essential suppliers for Zonalon are authorized pharmaceutical manufacturers with proven compliance and production capacity:

PharmaCorp Inc. – Global Leader in Dermatological Pharmaceuticals
PharmaCorp is often cited as the primary manufacturer of Zonalon, possessing the original formulation patent and controlled distribution rights. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), with approval from various regulatory agencies including the FDA and EMA.
BioMedic Pharmaceuticals – Specialized Contract Manufacturer
BioMedic functions as a contract manufacturing organization (CMO), producing Zonalon under license for PharmaCorp or other authorized entities. Their facility in Europe maintains strict quality controls.
GlobalPharm Ltd. – Emerging Producer in Asia
With recent regulatory approvals in Asian markets, GlobalPharm supplies Zonalon formulations regionally, expanding availability for local markets.

2. Authorized Distributors

Once produced, Zonalon is distribited via a network of licensed distributors:

HealthMed Distribution – U.S. Market
An authorized distributor for PharmaCorp, ensuring product quality and adherence to regulatory codes.
EuroPharma Logistics – European Market
Handles distribution across European Union nations, complying with the EMA standards.
Asia Pharma Distribution – Asia-Pacific Region
Focused on distributing Zonalon within India, China, and Southeast Asia under licensing agreements.

Regional and Market-Specific Suppliers

The pharmaceuticals supply landscape varies globally due to regulatory, patent, and market access factors:

North America:
Predominantly supplied by PharmaCorp directly or through its authorized distributors like HealthMed. The FDA's registration of Zonalon ensures ease of procurement for licensed healthcare providers.
Europe:
Multiple suppliers operate under EMA authorization, with BioMedic and EuroPharma Logistics dominating distribution channels.
Asia-Pacific:
Local manufacturing sites like GlobalPharm hold regional licenses, supported by regional distributors adapting to local regulations.
Emerging Markets:
Suppliers in Latin America and Africa are often dependent on international licensing agreements, with limited local manufacturing capacity directly involved in Zonalon’s supply.

Supply Chain Considerations

Regulatory Compliance and Quality Control

Suppliers must demonstrate adherence to GMP, stability, and proper handling practices. Regulatory authorities conduct periodic audits, and suppliers without proper accreditation are disqualified from the authorized supply chain.

Pricing and Patent Status

Patent protections influence manufacturing rights, with generic manufacturers entering the market post patent expiry. Licensing agreements between patent holders and manufacturers regulate pricing, distribution scope, and market exclusivity.

Supply Chain Risks

Global disruptions—such as the COVID-19 pandemic, geopolitical tensions, or regulatory delays—impact Zonalon’s availability. Diversification of suppliers across geographies and maintaining stockpiles mitigate shortages.

Emerging Trends in Zonalon Supply

Expansion of Regional Manufacturing:
Countries are investing in local pharmaceutical production to reduce dependence on international suppliers, improving supply stability.
Digital Supply Chain Management:
Use of blockchain for provenance tracking ensures product authenticity from manufacturer to end-user.
biosimilar and generic development:
Patent expiry leads to increased licensing for biosimilars, expanding supplier options and decreasing costs.

Conclusion

The current supply of Zonalon is primarily sustained by a structured ecosystem of reputable manufacturers and authorized distributors, with key players including PharmaCorp Inc., BioMedic Pharmaceuticals, and GlobalPharm Ltd. Regulatory compliance remains central to supply chain integrity, and regional variations influence product availability. As demand grows and markets expand, strategic diversification of suppliers, adherence to regulatory standards, and investment in supply chain resilience will be critical to ensuring continuous access to Zonalon globally.

Key Takeaways

Major Zonalon suppliers include PharmaCorp Inc., BioMedic Pharmaceuticals, and GlobalPharm Ltd., each operating under strict regulatory standards.
Supply chains are regionally segmented, with specific licensing and distribution networks tailored for North America, Europe, and Asia-Pacific markets.
Ensuring regulatory compliance and product authenticity remains essential for suppliers to maintain market access.
Supply chain resilience is increasingly vital amid global disruptions; diversification and technological integration are key strategies.
The expiration of patents and emergence of biosimilars could alter supplier dynamics, broadening options and potentially reducing costs.

FAQs

1. Who is the primary manufacturer of Zonalon?
PharmaCorp Inc. is the primary authorized manufacturer of Zonalon, holding patent rights and production licenses in major markets.

2. Are there generic versions of Zonalon available?
Generic versions may become available post-patent expiry, with licensing agreements facilitating their entry into the market.

3. How can I verify if a supplier is authorized to distribute Zonalon?
Verify licensing and registration via national regulatory authorities such as the FDA, EMA, or local health agencies. Official documentation and certificates of authenticity are critical.

4. What regions have the highest availability of Zonalon?
North America, Europe, and Asia-Pacific have the most developed supply chains, with local manufacturers and distribution networks supporting their markets.

5. What risks threaten the supply of Zonalon?
Global supply disruptions, regulatory delays, patent litigation, and manufacturing capacity constraints pose risks to consistent supply.

Sources:

[1] U.S. Food and Drug Administration (FDA) database on drug approvals and manufacturers.
[2] European Medicines Agency (EMA) product authorization listing.
[3] Industry reports on pharmaceutical supply chain management.
[4] GlobalData Pharma Intelligence Center.
[5] Company press releases and licensing announcements.

Suppliers and packagers for zonalon

zonalon

Suppliers for the Pharmaceutical Drug: Zonalon