flutamide: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780	ANDA	Cipla USA Inc.	69097-915-12	500 CAPSULE in 1 BOTTLE (69097-915-12)	2016-09-21
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780	ANDA	Cipla USA Inc.	69097-915-91	180 CAPSULE in 1 BOTTLE (69097-915-91)	2016-09-21
Waylis Therap	FLUTAMIDE	flutamide	CAPSULE;ORAL	075298	ANDA	Waylis Therapeutics LLC	80725-143-18	1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC	2021-11-12
Waylis Therap	FLUTAMIDE	flutamide	CAPSULE;ORAL	075298	ANDA	Waylis Therapeutics LLC	80725-600-18	1 BOTTLE, PLASTIC in 1 BOX (80725-600-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC	2021-11-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Flutamide is a non-steroidal anti-androgen used primarily in the treatment of prostate cancer and off-label in certain dermatological conditions such as hirsutism. As an essential drug within oncology and endocrinology, the supply chain for flutamide is critical for healthcare providers worldwide. This analysis offers an in-depth overview of key suppliers, manufacturing landscapes, and factors influencing the availability of flutamide, equipping stakeholders with actionable insights for procurement, strategic sourcing, and market analysis.

Chemical Profile and Market Context of Flutamide

Developed in the late 1960s and approved for clinical use in the 1980s, flutamide's chemical designation is 2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide. Its commercial availability hinges on several manufacturing geographies, regulatory environments, and distribution agreements. The drug’s patent status influences supply dynamics, with many formulations now off-patent and produced by multiple generic manufacturers.

Leading Manufacturers and Suppliers of Flutamide

1. Commercial Pharmaceutical Manufacturers

a. Bayer AG

Historically a primary supplier, Bayer produced the brand-name formulations of flutamide. Although Bayer's patent expired in many jurisdictions, the company's legacy manufacturing facilities and distribution channels hold significant market influence.
Bayer's emphasis on quality assurance and regulatory compliance ensures consistent product standards, critical in oncological treatments where safety is paramount.

b. Teva Pharmaceuticals

A prominent global generic drug producer, Teva is among the leading suppliers of off-patent flutamide. Their extensive manufacturing infrastructure, including facilities in Israel and the U.S., enables high-volume production.
Teva's manufacturing adheres to international cGMP standards, ensuring regulatory acceptance across markets.

c. Mylan (now part of Viatris)

As a key player in generics, Mylan's production capacity encompasses flutamide with distribution in North America, Europe, and emerging markets.
The company's strategic focus on affordable medicines enhances access to flutamide in low-income settings, especially where prostate cancer prevalence is rising.

d. Sandoz (Novartis Group)

Sandoz supplies flutamide as part of its broader oncology generics portfolio, leveraging its global manufacturing footprint.
Sandoz’s commitment to quality and supply chain resilience positions it as a dependable supplier in the oncology space.

2. Regional and Local Manufacturers

Additional local manufacturers operate in regions such as India, China, and Eastern Europe, often supplying genetically diverse markets at competitive prices.
Companies like Dr. Reddy’s Laboratories (India), Hengshan Pharmaceutical (China), and Pharmacia & Upjohn have historically produced flutamide under local regulatory licenses.
These manufacturers often source raw materials from regional chemical suppliers and may supply generic formulations for local distribution.

3. Raw Material Suppliers and API Producers

The active pharmaceutical ingredient (API) supplier landscape is critical for the stability of flutamide’s supply chain.

Key API producers in China and India—such as Zhejiang Meinuo Pharmaceutical and Hainan Yedakang Pharmaceutical—supply high-purity flutamide API to finished drug manufacturers worldwide.
Vertical integration among API producers and finished product manufacturers improves supply chain robustness but also raises concerns about regulatory oversight and quality consistency.

Supply Chain Dynamics and Market Factors

Regulatory Environment

The expiration of patents in various jurisdictions has democratized manufacturing but increased market competition.
Regulatory alignment by agencies like the U.S. FDA, EMA, and PMDA influences supplier registration, licensure, and import/export capabilities.

Manufacturing Capacity and Quality Standards

In response to global demand, manufacturers have expanded capacities, yet disruptions—from raw material shortages to geopolitical issues—can impact supply.
Stringent quality control measures and GMP adherence are vital, especially in oncology medicinals like flutamide.

Pricing and Market Access

The entry of multiple generic manufacturers has driven price competition, making flutamide accessible but also influencing profit margins for suppliers.
Procurement strategies often involve multiple suppliers to mitigate risks of shortages, especially in countries with high prostate cancer burdens.

Emerging Trends Affecting Flutamide Suppliers

Shift towards Novel Anti-Androgens: The advent of drugs like enzalutamide and apalutamide, which offer improved efficacy, may impact the demand for flutamide, consequently influencing supplier focus and investment.
Regulatory Reforms and Patent Expirations: Accelerating approval processes for generics and biosimilars may attract new suppliers and diversify the market.
Supply Chain Resilience: COVID-19 disruptions underscored the importance of diversified sourcing, prompting procurement strategies that involve multiple regional suppliers.
Environmental and Regulatory Stringency: Stricter chemical manufacturing emissions standards influence API producers’ operations, potentially constraining supply and increasing costs.

Strategic Implications for Stakeholders

For Healthcare Providers: Secure multiple supplier contracts to ensure continuity of supply given the volatility in API production and regional manufacturing margins.
For Distributors and Wholesalers: Stay abreast of regulatory approvals and market entry of new suppliers, particularly from emerging manufacturing hubs.
For Policymakers: Encourage cultivation of a diversified supplier base, including local API manufacturing capacity, to improve access and reduce dependency on limited regions.
For Raw Material Suppliers: Invest in quality systems and scalable capacity to meet increasing global demand, especially from generic producers.

Key Takeaways

Dominant Global Suppliers: Bayer, Teva, Mylan (Viatris), and Sandoz drive most of the global flutamide supply, with strong manufacturing and distribution networks.
Regional Manufacturing Significance: India and China host numerous regional API and drug formulators, contributing substantially to the supply chain, particularly for developing markets.
Market Vulnerabilities: Dependence on specific regions for API production and finished goods creates supply risks; diversification remains essential.
Market Dynamics: Patent expirations and regulatory harmonization facilitate increased generic competition, exerting downward pressure on prices but necessitating strategic sourcing.
Future Outlook: The evolving landscape of anti-androgen therapies, regulatory reforms, and supply chain resilience initiatives will shape future supplier relationships and market stability.

FAQs

1. Who are the top global manufacturers of flutamide?
Bayer, Teva, Mylan (Viatris), and Sandoz are the leading global manufacturers, each offering various formulations primarily in generic markets.

2. Are there regional suppliers specializing in flutamide?
Yes, Indian and Chinese pharmaceutical companies are significant regional suppliers, often producing generic versions for local and emerging markets.

3. How does patent expiration influence the supply of flutamide?
Patent expirations have increased the number of generic manufacturers, diversifying supply sources but also leading to increased market competition and price reductions.

4. What factors should healthcare providers consider when sourcing flutamide?
Providers should assess supplier reliability, regulatory approval status, manufacturing quality standards, and supply chain stability.

5. How might emerging anti-androgen therapies impact flutamide supply?
Newer therapies with superior efficacy may reduce demand for flutamide, influencing supplier investment and manufacturing focus in the long term.

References

European Medicines Agency. Flutamide: Summary for the public. EMA. (Accessed 2023).
U.S. Food and Drug Administration. Drug Applications & Approvals. FDA. (2022).
Market Intelligence Reports. Global Prostate Cancer Therapeutics Market Analysis. IQVIA. (2022).
Chemical & Pharmaceutical Manufacturer Data. API Suppliers Directory. CPhI Insights. (2023).
Industry Journals. Blazing Trends in Oncology Pharmaceutical Supply Chains. PharmaFocus. (2022).

Suppliers and packagers for flutamide

flutamide

Suppliers for the Pharmaceutical Drug: Flutamide