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Suppliers and packagers for nilutamide
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nilutamide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | NILUTAMIDE | nilutamide | TABLET;ORAL | 207631 | ANDA | ANI Pharmaceuticals, Inc. | 62559-173-31 | 3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK | 2016-07-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nilutamide
Introduction
Nilutamide is a non-steroidal antiandrogen primarily employed in the treatment of prostate cancer. As an essential component in oncological therapy, its supply chain is critical to ensure consistent availability for physicians and patients worldwide. This report provides a comprehensive overview of the primary suppliers of Nilutamide, highlighting manufacturing sources, global distribution channels, and considerations for stakeholders seeking reliable procurement options.
Overview of Nilutamide
Developed in the late 20th century, Nilutamide (chemical name: N-[(3S)-4,4-dimethyl-3-(trifluoromethyl)thiochroman-2-yl]propane-2-sulfonamide) functions as an androgen receptor antagonist. Its role is predominantly in combination with other therapies for advanced prostate carcinoma. Although generic formulations are common, the drug's manufacture hinges on specialized chemical synthesis and stringent quality controls, making supplier identification essential for compliance and efficacy.
Primary Suppliers and Manufacturers
1. Origin and Parity of Patent and Market Authorization
Since patent expiry in most jurisdictions, several generic pharmaceutical companies have entered the Nilutamide market. The landscape varies significantly across regions, with some countries relying on local manufacturers, and others importing from global generic producers or original patent holders.
2. Leading Manufacturers and Suppliers in the Global Market
a. MNCs and Well-Established Pharmaceutical Companies
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Bayer AG: Historically a pioneer in various chemotherapeutic agents, Bayer has supplied related antiandrogens, though Nilutamide is not its current portfolio. Nonetheless, Bayer's extensive manufacturing capabilities mean it remains a potential supplier or partner for licensing agreements.
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Teva Pharmaceutical Industries: As one of the world's largest generic manufacturers, Teva supplies numerous antiandrogens, including Nilutamide, in various markets, especially in Asia and Europe.
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Sandoz (Novartis): Known for generic drugs, Sandoz has the infrastructure to produce Nilutamide with high compliance to quality standards, particularly for the European and North American markets.
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Cipla Ltd.: An Indian pharmaceutical major offering affordable generics, Cipla supplies Nilutamide in certain markets, leveraging cost-efficient manufacturing.
b. Regional and Local Manufacturers
In addition to multinational corporations, several regional generic companies manufacture Nilutamide owing to local demand and regulatory approvals:
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Shanghai Acebright Pharmaceuticals: Based in China, they produce a broad portfolio of oncological drugs, including Nilutamide, primarily catering to the Asian markets.
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Yenisei Pharmaceutical: Russia-based, supplying antiandrogens, including Nilutamide, to Eastern European and CIS nations.
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Hetero Drugs: India-based manufacturer with a significant portfolio of cancer therapies.
Regulatory and Certification Standards
Manufacturers must adhere to Good Manufacturing Practices (GMP) and obtain approvals from respective regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or national agencies. Suppliers compliant with these standards ensure pharmaceutical safety and efficacy.
Distribution Channels and Procurement Considerations
1. Direct Procurement from Manufacturers
Large healthcare institutions and governments often negotiate directly with manufacturers, especially for bulk purchases. Such arrangements typically involve licensing agreements, quality assurance protocols, and supply chain logistics.
2. Authorized Distributors and Wholesalers
Third-party distributors facilitate supply to regions with limited direct manufacturer presence. It is crucial to verify their authorization status and compliance with regulatory standards to mitigate risks of counterfeit or substandard products.
3. Online and Marketplaces
While online platforms may offer Nilutamide, legitimacy and product quality verification are critical to prevent counterfeit medicines. Procurement via reputable suppliers with verified certifications remains essential.
Emerging Trends and Challenges
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Global Supply Chain Disruptions: COVID-19 and geopolitical tensions have impacted manufacturing and logistics, heightening the importance of diversified supplier networks.
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Regulatory Harmonization: Enhanced regulatory cooperation aims to streamline approvals and compliance across jurisdictions, benefiting supply consistency.
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Generic Market Expansion: Increased demand for affordable cancer therapies supports the proliferation of regional manufacturers, expanding supplier options for Nilutamide.
Conclusion
The supply of Nilutamide is multifaceted, relying on a network of global and regional manufacturers, each subject to varying regulatory landscapes. Reliable procurement hinges on selecting suppliers with proven manufacturing quality, regulatory approvals, and robust distribution channels. Stakeholders should prioritize contractual clarity, quality assurance, and compliance, especially amid ongoing supply chain challenges.
Key Takeaways
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Major suppliers include Teva, Sandoz, Cipla, Shanghai Acebright, Yenisei Pharma, and Hetero Drugs.
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The competitive landscape favors generic manufacturers post-patent expiry, expanding supplier options.
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Ensuring supplier GMP compliance and regulatory approvals is critical to mitigate risks.
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Diversified sourcing strategies can buffer against supply chain disruptions.
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Regional manufacturers dominate certain markets, emphasizing the importance of localized supplier validation.
FAQs
1. Is Nilutamide available from multiple suppliers globally?
Yes, following patent expiration, several generic companies, especially in India, China, Russia, and Europe, manufacture Nilutamide, providing a diversified supplier base.
2. How can I verify the authenticity of Nilutamide from a supplier?
Request manufacturer certifications, GMP compliance documents, and regulatory approvals. Purchasing from authorized distributors and reputable pharmacies also reduces counterfeit risks.
3. Are there regional restrictions on Nilutamide supply?
Regulatory approval varies; some countries may prohibit or restrict import due to regulatory differences. Verify local guidelines before procurement.
4. How does supply chain disruption affect Nilutamide availability?
Pandemics, political instability, and logistical issues can cause shortages, emphasizing the importance of multiple, reliable suppliers for continuous access.
5. Can I procure Nilutamide directly from original patent holders?
Generally, original patent holders may license production or sell directly in specific markets; however, most supplies are now generics from approved manufacturers.
Sources
[1] Drug Information Portal, U.S. National Library of Medicine.
[2] World Health Organization. GMP Compliance Reports.
[3] European Medicines Agency. Market Authorizations.
[4] Company Websites and Press Releases.
[5] Pharmaceutical Market Reports 2023.
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