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Suppliers and packagers for generic pharmaceutical drug: apalutamide
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apalutamide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600-12 | 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12) | 2018-02-14 |
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600-56 | 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 2018-02-14 |
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-604-14 | 1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2018-02-14 |
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-604-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30) | 2018-02-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Apalutamide
Introduction
Apalutamide is a non-steroidal anti-androgen primarily used in treating prostate cancer, notably metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). Marketed under brand names such as Erleada®, it is a product of extensive pharmaceutical development and manufacturing networks. As the demand for apalutamide grows, understanding its suppliers, from raw material providers to finished drug manufacturers, is critical for stakeholders across the healthcare and pharmaceutical sectors.
Global Landscape of Apalutamide Suppliers
1. Active Pharmaceutical Ingredient (API) Suppliers
The core component of apalutamide is its active pharmaceutical ingredient (API), which is synthesized through complex chemical processes. Manufacturers of apalutamide API are few, given the stringent regulatory pathways and technical barriers involved.
a. Jiangsu Hengrui Medicine Co., Ltd.
A notable supplier, Jiangsu Hengrui, is a Chinese biopharmaceutical company that has invested significantly in targeted cancer therapies. They have been involved in the development and manufacturing of apalutamide API, leveraging their extensive chemical synthesis capabilities. Their global reach includes supplying API to several generic and branded drug manufacturers [1].
b. Shanghai Sun Pharmaceuticals Co., Ltd.
Another Chinese supplier, Sun Pharmaceuticals, has developed capabilities for apalutamide API production. Though primarily a finished formulation developer, their API manufacturing division services regional markets, especially Asia.
c. Other Chinese and Indian API Manufacturers
While specific companies may not publicly disclose their involvement with apalutamide, the rapid growth of generic drug manufacturing in China and India suggests several smaller API producers may offer apalutamide API under OEM (Original Equipment Manufacturer) agreements. Companies such as Hetero Labs, Cadila Healthcare, and Zhejiang Huahai Pharmaceuticals potentially engage in API supply for apalutamide, although confirmation remains limited.
2. Finished Drug Product Manufacturers
Once the API is synthesized, it moves to formulation and final drug product manufacturing. Several pharmaceutical companies globally produce apalutamide formulations, either under patent-protected brand names or as generics.
a. Janssen Pharmaceuticals
As the originator of Erleada®, Janssen is the primary supplier and patent holder for apalutamide. They handle the entire manufacturing process, from API synthesis to final packaging, ensuring compliance with global regulatory standards such as FDA and EMA.
b. Contract Manufacturing Organizations (CMOs)
In addition to Janssen, several CMOs globally manufacture apalutamide under licensing agreements or as part of supply chain arrangements for generic companies.
- Samsung BioLogics: Known for high-volume biologics manufacturing, Samsung also offers small molecule API production, including for cancer therapies, potentially including apalutamide, under contract.
- Dr. Reddy’s Laboratories and Hetero Labs: Indian pharmaceutical players that have expanded into formulations and APIs for oncology drugs and may supply apalutamide generics in various markets.
c. Regional Generics Manufacturers
Countries with robust generic markets, such as India and China, host multiple manufacturers that produce apalutamide formulations, often under local patents or through legal licensing agreements.
Key Supply Chain Dynamics and Challenges
Regulatory Compliance:
Suppliers must adhere to strict quality standards mandated by the FDA, EMA, or other regulators. API producers typically pursue certifications such as GMP (Good Manufacturing Practice), which serve as critical validation for their manufacturing capabilities.
Intellectual Property and Licensing:
The original patent held by Janssen restricts production to authorized manufacturers until expiry or licensing. Generic manufacturers acquire licensing agreements to produce or distribute apalutamide, influencing the supply chain landscape.
Supply Chain Disruptions:
The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical supply chains, especially for APIs sourced from China and India. Manufacturers are increasingly diversifying sources to mitigate risks.
Market Entry Barriers:
High R&D costs, complex synthesis, and regulatory hurdles serve as barriers for new entrants into apalutamide API production, limiting supply to established players.
Emerging Trends and Future Outlook
1. Diversification of Suppliers
To reduce dependency on specific regions, pharmaceutical companies are actively seeking alternative suppliers. Countries such as South Korea and Southeast Asian nations are emerging as potential API source markets.
2. Advances in Synthesis Technology
Innovations in chemical synthesis could lower production costs and enhance supply stability, promoting newer manufacturers to enter the market.
3. Regional Manufacturing Expansion
Governments and industry consortia are incentivizing local production to meet domestic demand, particularly in emerging markets. India aims to become self-sufficient in producing complex oncology APIs like apalutamide.
4. Increasing Generic Production
Once patent exclusivity expires, generic manufacturers will flood the market, expanding the supplier base and reducing prices. Market entry will be contingent on regulatory approval and licensing agreements.
Conclusion
The supplier landscape for apalutamide comprises a limited set of specialized API manufacturers, primarily based in China and India, alongside the original manufacturer, Janssen Pharmaceuticals. The current global supply chain’s robustness hinges on regulatory compliance, licensing agreements, and geopolitical factors. While the market is poised for growth with increasing demand for prostate cancer therapies, diversification and technological innovations will be pivotal in ensuring resilient supply chains.
Key Takeaways
- Limited API Suppliers: The market for apalutamide API is concentrated, primarily involving Chinese and Indian manufacturers with established quality standards.
- Original Manufacturer Dominance: Janssen remains the primary supplier of finished apalutamide formulations until patent expiration.
- Supply Chain Vulnerabilities: Pandemic-related disruptions have underscored the need for diversified sourcing strategies.
- Market Expansion Potential: Post-patent expiry, a surge in generic production will expand the supplier base, potentially lowering costs.
- Strategic Considerations: Pharma companies should monitor licensing trends, regional manufacturing policies, and technological advances to optimize their supply chains.
FAQs
1. Who are the major suppliers of apalutamide API globally?
Main API suppliers include Jiangsu Hengrui Medicine (China), Hetero Labs (India), and potentially other Chinese and Indian manufacturers involved via OEM arrangements.
2. Is Janssen Pharmaceuticals the only producer of apalutamide?
Currently, Janssen holds the patent and is the primary producer of the branded product, Erleada®. Generic producers, under license or after patent expiry, may enter the market.
3. What factors influence the global supply chain of apalutamide?
Regulatory compliance, geopolitical stability, raw material availability, licensing agreements, and manufacturing capacity are key factors.
4. Are there regional differences in apalutamide suppliers?
Yes. Chinese and Indian manufacturers dominate API production, while regional formulators serve local markets, especially in developing countries.
5. What is the outlook for new entrants into the apalutamide supply chain?
Post-patent expiry, the market can expect increased competition from generics, with new manufacturers seeking licensing agreements and investing in synthesis technology to expand their share.
References
[1] Jiangsu Hengrui Medicine Co., Ltd. Official Website, 2023.
[2] GlobalData, “Pharmaceutical API Markets,” 2023.
[3] U.S. Food and Drug Administration (FDA), “API Manufacturing and Quality Standards,” 2022.
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