Suppliers and packagers for PROSCAR

PROSCAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	PROSCAR	finasteride	TABLET;ORAL	020180	NDA	Organon LLC	78206-153-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01)	2021-06-01
Organon	PROSCAR	finasteride	TABLET;ORAL	020180	NDA	Organon LLC	78206-153-02	100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)	2021-06-01

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: PROSCAR

Introduction

PROSCAR, with the generic name finasteride, is a widely prescribed pharmaceutical primarily used to treat benign prostatic hyperplasia (BPH) and male pattern baldness (androgenetic alopecia). Developed and marketed by Merck & Co., Inc., this drug has become a staple in urological and dermatological treatments. The global supply chain for PROSCAR involves a network of manufacturing partners, raw material providers, and authorized distributors, all working within the framework of regulatory standards to ensure product safety and efficacy. This article provides a comprehensive overview of the primary suppliers involved in the production and distribution of PROSCAR, examining manufacturing sources, raw material suppliers, distribution channels, and regulatory considerations.

Manufacturers of PROSCAR

Merck & Co., Inc.
As the originator and primary brand owner of PROSCAR, Merck is responsible for the manufacturing, marketing, and distribution of the drug globally. Based in the United States, Merck’s manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP) mandated by regulatory bodies such as the FDA (Food and Drug Administration) in the U.S., EMA (European Medicines Agency) in Europe, and other national authorities. Merck’s proprietary manufacturing processes ensure the consistency, purity, and potency of PROSCAR across markets.

Manufacturing Partners and Contract Manufacturers
While Merck maintains control over core production, the company likely employs Contract Manufacturing Organizations (CMOs) to meet global demand. CMOs are specialized firms that follow Merck’s specifications to produce active pharmaceutical ingredients (APIs) and finished drug products. Notable CMOs in the pharmaceutical industry with capacity for finasteride include companies such as FAMAR (Ireland), Venture Life Sciences (UK), and CMOs in India and China that operate under strict regulatory compliance to meet international standards.

Raw Material Suppliers: The Backbone of Finasteride Production

Active Pharmaceutical Ingredient (API) Sourcing
Finasteride, the active component of PROSCAR, requires high-quality raw materials for synthesis. API production involves several chemical intermediates, reagents, and solvents derived from specialized suppliers. The primary raw material suppliers include chemical companies from regions with a robust pharmaceutical manufacturing sector, notably China, India, Germany, and South Korea.

Key Suppliers of Finasteride API

• Dr. Reddy’s Laboratories (India): A significant player in API supply, known for producing bulk finasteride for various markets.
• Mingzhu Pharmaceutical (China): Reports indicate Chinese companies like Mingzhu produce APIs for export, including finasteride, adhering to GMP standards for international sales.
• Siegfried AG (Switzerland): A global API manufacturer that produces a range of pharmaceutical APIs, including finasteride, for multinational clients.

Regulatory Compliance
These raw material suppliers must meet rigorous standards such as GMP, ISO certifications, and EMA or FDA inspections. Many are audited by Merck or third-party agencies to ensure quality, impurity control, and traceability.

Distribution Channels and Licensed Distributors

Global Distribution Network
After manufacturing, PROSCAR is distributed through a network of authorized wholesalers, pharmacies, hospitals, and specialty clinics. Merck's global distribution infrastructure ensures consistent supply, with regional warehouses tailored to local regulatory and market demands.

Major Distributors

• McKesson Corporation and AmerisourceBergen in North America handle a substantial portion of the U.S. distribution, given their extensive pharmaceutical logistics networks.
• Alliance Healthcare (part of McKesson) and Phoenix Group cover European markets.
• In Asia and emerging markets, local distributors often partner with international pharmaceutical companies to ensure access to PROSCAR.

Regulatory and Patent Considerations
While patent protections for PROSCAR expired in several regions around 2017, generic finasteride remains available from multiple manufacturers, increasing competition and supply options. Generic versions are distributed by firms such as Cipla, Sun Pharmaceutical Industries, Torrent Pharmaceuticals, and Mylan (now part of Viatris).

Generic Finasteride Manufacturers

The availability of generic finasteride has diversified the supply landscape. These manufacturers produce bioequivalent versions, often at lower prices but under strict regulatory oversight. The key players include:

• Cipla Ltd. (India): A leading manufacturer of generic finasteride with global export capabilities.
• Sun Pharmaceutical Industries (India): Large production capacity supplying both the domestic and international markets.
• Viatris (formerly Mylan): U.S.-based company with global manufacturing plants producing generic finasteride.
• XK Pharma (India): A notable player in the generic segment, supplying to multiple markets.

Regulatory Landscape Impacting Suppliers

The supply chain for PROSCAR is heavily influenced by regulatory authorities, especially considering the drug's patent expiration and increasing generic competition. Compliance with the FDA’s DMF (Drug Master File) submissions, EMA certifications, and compliance with ICH guidelines are essential for both original and generic suppliers. Regulatory approvals also determine which suppliers can access major markets, influencing supply stability.

Emerging Trends and Challenges in the Supply Chain

Supply Chain Disruptions
Recent global events such as the COVID-19 pandemic, logistical bottlenecks, and trade tensions have impacted raw material procurement and manufacturing timelines. Suppliers in China and India experienced delays, affecting the production of both proprietary and generic finasteride.

Quality Assurance and Traceability
Healthcare providers and regulators demand rigorous quality assurance. Suppliers undergo regular audits, and traceability systems are in place to prevent contamination or substandard manufacturing. This is especially pertinent for APIs sourced from high-volume suppliers in China and India.

Sustainability and Regulatory Shifts
Sustainable manufacturing practices are increasingly prioritized. Environmental regulations in the EU and U.S. influence suppliers’ operations, encouraging greener API synthesis and packaging processes.

Key Takeaways

• Merck & Co. remains the primary manufacturer of PROSCAR, controlling core production with support from CMOs worldwide.
• The raw material supply chain predominantly relies on API manufacturers in China, India, and Europe, adhering to GMP standards.
• The competitive landscape has expanded significantly post-patent expiration, with prominent generics producers like Cipla, Sun Pharma, and Viatris supplying the market.
• Distribution networks involve major global wholesalers, facilitating access across North America, Europe, and emerging markets.
• Regulatory compliance, supply chain resilience, and quality assurance are critical factors influencing supplier stability and product availability.

Key Takeaways

• Maintain awareness of patent status and the rise of generics to gauge supply price and availability trends.
• Ensure sourcing from GMP-compliant API manufacturers to mitigate quality risks.
• Understand regional distribution channels to assess market access and logistical challenges.
• Monitor regulatory developments that could influence supplier operations or drug approval pathways.
• Stay attuned to geopolitical and supply chain risks that could impact raw material availability and manufacturing continuity.

FAQs

1. Who are the main manufacturers of PROSCAR?
Merck & Co. is the primary manufacturer, with additional production support from contract manufacturing organizations (CMOs) worldwide, especially in Asia and Europe.

2. Are there alternative suppliers for finasteride's raw materials?
Yes, key API suppliers include companies like Dr. Reddy's (India), Mingzhu Pharmaceutical (China), and Siegfried AG (Switzerland).

3. How does patent expiration affect the supply chain?
Patent expiration allows multiple generic manufacturers to produce finasteride, increasing supply options, reducing costs, and broadening market availability.

4. What regulatory standards do suppliers need to meet?
Suppliers must adhere to GMP, ISO, and regional regulatory approvals (FDA, EMA), ensuring quality and safety of raw materials and finished products.

5. How might supply chain disruptions impact PROSCAR availability?
Disruptions in raw material supply or manufacturing delays can lead to shortages, affecting patient access and pricing stability. Monitoring geopolitical and logistical developments is essential for risk management.

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Sources
[1] Merck & Co. official product information
[2] U.S. Food & Drug Administration, Drug Master Files (DMFs)
[3] European Medicines Agency (EMA) approval documents
[4] Global API manufacturing reports, industry analyses
[5] Patent and industry journal articles on finasteride market dynamics