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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	NILANDRON	nilutamide	TABLET;ORAL	020169	NDA	Advanz Pharma (US) Corp.	59212-111-14	3 BLISTER PACK in 1 CARTON (59212-111-14) / 10 TABLET in 1 BLISTER PACK	2013-07-15
Advanz Pharma	NILANDRON	nilutamide	TABLET;ORAL	020169	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-212-38	3 BLISTER PACK in 1 CARTON (66993-212-38) / 10 TABLET in 1 BLISTER PACK	2019-11-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

NILANDRON (nilutamide) is an antiandrogen medication primarily used in treating prostate cancer, particularly as part of androgen deprivation therapy. As a non-steroidal antiandrogen, NILANDRON plays a vital role in hormonal management strategies. Identifying reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and distributors to ensure consistent drug availability, regulatory compliance, and quality assurance.

This report provides a comprehensive overview of the global supply landscape for NILANDRON, including key manufacturers, geographic distribution, regulatory considerations, and future sourcing trends.

Overview of NILANDRON (Nilutamide)

Developed in the late 20th century, NILANDRON is produced by pharmaceutical firms under strict regulatory standards. It is marketed under various brand names and formulations, depending on the country and manufacturer. Authenticity, potency, and safety are critical parameters; thus, sourcing from registered, reputable suppliers is imperative to mitigate counterfeit risks and ensure therapeutic efficacy.

Global Manufacturers and Suppliers

1. AstraZeneca

AstraZeneca pioneered NILANDRON's development and marketing. The company has historically been the primary global supplier, especially during the drug’s early commercial phases. AstraZeneca’s manufacturing facilities are equipped with advanced quality controls, adhering to Good Manufacturing Practices (GMP), certifying the integrity of the supply chain.

Regional presence:
AstraZeneca's manufacturing sites in the UK, Sweden, and the United States have supplied NILANDRON to various markets worldwide. Their distribution networks cover Europe, North America, and select Asian countries through regional subsidiaries or licensed partners.

Regulatory status:
In many countries, AstraZeneca is the sole registered manufacturer of NILANDRON, with regulatory approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities.

2. Licenses and Outsourcing Agreements

In some regions, licensing agreements allow local pharmaceutical companies to manufacture or distribute NILANDRON under AstraZeneca’s authorization. This approach enhances local supply capacity and compliance with regional regulatory standards. For example, in certain Asian markets such as India and China, licensed pharmaceutical firms produce NILANDRON domestically, supplied under AstraZeneca’s oversight.

3. Generics Manufacturers and Alternative Suppliers

While NILANDRON remains primarily produced by AstraZeneca, the patent landscape and regulatory approvals have enabled the development of generic formulations by various manufacturers, particularly following patent expiration or patent challenge periods.

Key generic manufacturers include:

Sun Pharmaceutical Industries Ltd. (India):
Known for robust generic drug portfolios, they produce nilutamide under various brand names, supplying markets across Asia, Africa, and emerging economies.
Lupin Limited (India):
As a significant player in antiandrogens, Lupin manufactures and markets nilutamide generics with global distribution.
Dr. Reddy’s Laboratories (India):
Active in producing antiandrogens, including nilutamide to serve regional markets.
Medi-Fab (Egypt):
Produces generic nilutamide, mainly distributed in African and Middle Eastern regions.

Note: Many generic formulations are produced in offshore facilities, emphasizing the importance of rigorous quality assurance and regulatory compliance (e.g., WHO prequalification, country approvals).

4. Emerging Suppliers

New entrants in the pharmaceutical manufacturing sector, especially in regions like Southeast Asia and Latin America, are increasingly registering NILANDRON or generic equivalents, driven by regional demand and local market expansion. These suppliers often leverage established APIs (Active Pharmaceutical Ingredients) from reputable API manufacturers.

API (Active Pharmaceutical Ingredient) Supply Chain

The API supply chain for nilutamide is a critical determinant of drug quality and availability. Major API manufacturers include:

Zhejiang Hisun Pharmaceutical (China):
Offers bulk API manufacturing for generic antiandrogens, including nilutamide, with international quality certifications.
HUBEI Huida Pharmaceutical (China):
Produces high-quality nilutamide API utilized by licensed pharmaceutical companies.
Cambridge Isotope Laboratories (USA):
Supplies specialty raw materials and intermediates used in nilutamide production.

API sourcing from reputable Chinese and Indian manufacturers is common, given their scale, quality control, and cost advantages. However, strict validation and compliance with regulatory standards are necessary.

Regulatory Considerations

Sourcing NILANDRON requires navigating complex regulatory landscapes. Many nations require registration and approval of both finished dosage forms and APIs. Companies should verify:

Approved manufacturing facilities (GMP compliant)
Regulatory approvals in target markets
Supply chain traceability and documentation
Compliance with international standards such as WHO, MHRA, and TGA

Counterfeit or substandard imports pose significant risks, thus necessitating due diligence and supplier audits.

Future Trends and Strategic Sourcing

The global shift toward biosimilars and targeted therapies is influencing the prostate cancer treatment landscape, potentially impacting NILANDRON demand and supply chains. Meanwhile, patent expirations have opened pathways for increased generic competition:

Diversification of suppliers reduces dependence on AstraZeneca.
Regional manufacturing expansion enhances supply resilience.
Advanced API production techniques improve quality and reduce costs.

Pharmaceutical companies are investing in establishing partnerships with emerging API producers, fostering supply chain robustness, and ensuring compliance with evolving regulatory requirements.

Conclusion

The supply ecosystem for NILANDRON is predominantly led by AstraZeneca, backed by licensed regional manufacturers and a growing number of generic producers. Ensuring a reliable supply involves careful selection of manufacturers that meet stringent quality standards, navigate regulatory complexities, and provide cost-effective solutions. As treatment paradigms evolve, the strategic diversification of suppliers and strengthening of API supply chains remain essential.

Key Takeaways

Primary Supplier: AstraZeneca continues to be the main authorized manufacturer of NILANDRON globally.
Generics Market: Several Indian and Chinese companies produce licensed and generic formulations, expanding affordability and access.
API Sources: High-quality APIs are sourced mainly from China and India, requiring rigorous quality control.
Regulatory Compliance: Compliance with GMP and approval from health authorities are vital for supplier legitimacy.
Future Outlook: Ongoing patent expirations and regional manufacturing initiatives will diversify supply options and enhance resilience.

FAQs

1. Who are the leading manufacturers of NILANDRON globally?
AstraZeneca remains the primary global manufacturer, with licensed regional producers and generic drug companies such as Sun Pharma, Lupin, and Dr. Reddy’s offering alternative sources.

2. How can healthcare providers ensure the authenticity of NILANDRON supplies?
Providers should verify suppliers’ registration with regulatory authorities, request certification and batch documentation, and purchase through established distributors with quality assurance protocols.

3. What are the main regulatory challenges in sourcing NILANDRON?
Ensuring compliance with GMP, obtaining market-specific approvals, verifying API safety standards, and preventing counterfeit products are key challenges.

4. Are there regional differences in NILANDRON suppliers?
Yes. North America and Europe primarily rely on AstraZeneca, while Asian and African markets often source from Indian and Chinese generic manufacturers.

5. How might future patent expirations impact NILANDRON supply?
Patent expirations will likely increase generic competition, expanding supply options, reducing costs, and potentially leading to increased availability globally.

References

[1] AstraZeneca Official Website. “Nilandron (nilutamide) Information.”
[2] U.S. Food and Drug Administration (FDA). “Approved Drug Products – NDA Data.”
[3] World Health Organization. “Prequalification of Medicines Programme.”
[4] Indian Pharmaceutical Journal. “Generic manufacturing and API sourcing strategies.”

Suppliers and packagers for nilandron

nilandron

Suppliers for the Pharmaceutical Drug: NILANDRON (Nilutamide)