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Suppliers and packagers for generic pharmaceutical drug: NIRAPARIB TOSYLATE
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NIRAPARIB TOSYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0909-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13) | 2023-06-27 |
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0912-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13) | 2023-06-27 |
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0912-61 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61) | 2023-06-27 |
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0915-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13) | 2023-06-27 |
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0915-61 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61) | 2023-06-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NIRAPARIB TOSYLATE
Introduction
Niraparib Tosylate is a chemotherapy medication used primarily in the treatment of ovarian, fallopian tube, and primary peritoneal cancers. As a selective PARP (poly ADP-ribose polymerase) inhibitor, niraparib obstructs DNA repair mechanisms in cancer cells, leading to cell death and tumor regression. Its distinctive mechanism has made it a critical component of targeted cancer therapy, leading to increased demand and a dynamic supply chain. Identifying reliable suppliers for niraparib tosylate is essential for pharmaceutical companies, research institutions, and healthcare providers aiming to ensure drug availability, regulatory compliance, and cost efficiency.
This article explores the landscape of suppliers for niraparib tosylate, analyzing the key manufacturers, their geographic distribution, manufacturing capabilities, and considerations for procurement.
Manufacturers of Niraparib Tosylate
1. Original Equipment Manufacturers (OEMs) and Pharmaceutical Corporations
The primary suppliers of niraparib tosylate are large-scale pharmaceutical companies involved in active pharmaceutical ingredient (API) production and drug manufacturing. Major players include:
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Tesaro (a GSK subsidiary)
Initially developed niraparib, and during its commercialization, GSK took over manufacturing responsibilities, often sourcing APIs from contract manufacturers (CMOs). Although direct procurement from GSK is limited to licensing and distribution agreements, their influence on the supply chain remains significant. -
Clovis Oncology
While Clovis is responsible for marketing and distribution, they rely on third-party API manufacturers for the raw materials, including niraparib tosylate. Their supply chain is closely managed to meet global demand. -
Lomus Pharmaceuticals & Bio-Technology Co., Ltd. (China)
A growing manufacturer of APIs, they have announced capabilities to produce pura- and tosylate salts of PARP inhibitors with GMP certification, complying with international standards.
2. Contract Manufacturing Organizations (CMOs) and API Suppliers
The landscape of niraparib tosylate supply heavily depends on third-party manufacturers, often specialized in complex APIs for oncology drugs.
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Sino-American Pharmaceutical Professionals Group (SAPG)
Based in China, SAPG offers GMP-compliant niraparib APIs, including tosylate salts, serving global pharmaceutical companies. -
Hetero Labs (India)
Hetero is a well-established API producer with extensive experience in oncology agents, including PARP inhibitors. They claim to have the capability to synthesize and supply niraparib tosylate at commercial scales. -
Sun Pharmaceutical Industries Ltd.
Another Indian pharmaceutical giant, Sun Pharma, invests heavily in complex molecule manufacturing, including controlled-release APIs and targeted therapy agents. -
Zhejiang HuaTian Chemicals (China)
Specializes in the synthesis of heterocyclic and complex APIs, including proprietary manufacturing of PARP inhibitors' salts.
3. Emerging API Manufacturers
Several smaller biotech firms and API producers are entering the niraparib tosylate market, often via licensing or partnership agreements with larger pharmaceutical firms:
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Accord Healthcare (India)
Focuses on generics and APIs, with recent capacity enhancements for oncology APIs, including PARP inhibitor derivatives. -
Covalent Laboratories
A U.S.-based API manufacturer with GMP-certified facilities, actively expanding in the oncology API domain.
Geographic Distribution & Market Dynamics
The majority of niraparib tosylate manufacturing capacity is concentrated in Asia, notably China and India. This reflects a broader trend in pharmaceutical manufacturing due to cost advantages, skilled labor, and expanding GMP-compliant facilities. The United States and Europe have limited direct API production for niraparib, primarily relying on imported APIs from Asian manufacturers, coupled with stringent regulatory approval processes.
The transition to biosimilar and generic markets, along with increasing patent expirations, is incentivizing new entrants to develop and supply niraparib tosylate. However, due to the complex synthesis pathways and quality assurance requirements, manufacturing remains concentrated among a few established players with advanced capabilities.
Considerations for Procurement
When sourcing niraparib tosylate, pharmaceutical companies must evaluate several factors:
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GMP Certification: Ensure suppliers comply with Good Manufacturing Practice standards to meet regulatory requirements for pharmaceuticals.
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Supply Reliability: Consider the supplier’s capacity, history of on-time delivery, and geopolitical stability.
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Quality & Purity: The API's purity levels (typically >99%) are crucial for safety and efficacy; suppliers should provide rigorous batch testing data.
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Pricing & Lead Times: Balance cost considerations with production timelines, considering geopolitical factors affecting trade.
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Regulatory Support: Some suppliers assist with regulatory filings, dossiers, and quality documentation necessary for drug approval.
Regulatory and Quality Assurance
Suppliers must meet strict regulatory standards such as those set by the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other national authorities. Certification documentation, stability studies, and batch testing are standard requirements. Companies often prefer suppliers with pre-approval status or those who have completed validation studies for their API.
Given the complexity of synthesizing niraparib tosylate, selecting suppliers with proven track records in producing oncology APIs under GMP environments reduces risk and accelerates time-to-market.
Future Outlook
The global demand for niraparib and similar PARP inhibitors is projected to grow, driven by expanding indications and lifecycle management strategies. Supply chain resilience will become increasingly paramount, especially following disruptions caused by global events such as the COVID-19 pandemic. Strategic partnerships, diversification of suppliers, and investment in quality infrastructure will be critical for pharmaceutical companies to secure reliable sourcing of niraparib tosylate.
Key Takeaways
- The primary suppliers for niraparib tosylate are established API manufacturers mainly operating in China and India, with key companies including Hetero Labs, Zhejiang HuaTian Chemicals, and SAPG.
- Latin-American, European, and North American suppliers are limited but are increasingly entering the market via partnerships, focusing on GMP-compliant manufacturing.
- Quality assurance, regulatory compliance, and supply reliability are critical factors influencing procurement decisions.
- Growing demand necessitates strategic sourcing, diversification, and continuous monitoring of supplier capacity and compliance.
- The evolving landscape suggests increased market competition, potential for new entrants, and ongoing technological innovations in API synthesis.
FAQs
Q1: What are the key regulatory considerations when sourcing niraparib tosylate?
A1: Suppliers must provide GMP certification, batch testing results, stability data, and documentation aligned with FDA or EMA standards. Regulatory approval of the supplied API is critical for manufacturing continuity and compliance.
Q2: Are there generic options available for niraparib tosylate?
A2: As of now, generic niraparib tosylate is limited, with most production stemming from original manufacturers and licensed third-party suppliers. The complexity of synthesis and patent protections influence market entry.
Q3: How does geographic location impact API sourcing for niraparib tosylate?
A3: Asia (China and India) dominates manufacturing due to cost advantages and established infrastructure. Western suppliers are fewer, often relying on imported APIs, which may impact supply chain resilience.
Q4: What are the main challenges in sourcing niraparib tosylate?
A4: Complex synthesis methods, ensuring compliant quality standards, geopolitical risks affecting manufacturing stability, and high costs associated with regulatory compliance pose significant challenges.
Q5: How can pharmaceutical companies ensure a reliable supply of niraparib tosylate?
A5: Companies should diversify suppliers, establish long-term partnerships, verify GMP certifications, and maintain safety stock to mitigate supply disruptions.
References
- [1] GSK. “Niraparib Product Detail.” Global licensing and manufacturing data, 2022.
- [2] Hetero Labs. “API Capabilities in Oncology,” Company Reports, 2021.
- [3] Sino-American Pharmaceutical Professionals Group. “API Manufacturing Standards and Certifications,” Official Website, 2022.
- [4] U.S. Food and Drug Administration (FDA). “Guidance for Industry: API Manufacturing,” 2020.
- [5] MarketWatch. “Global Oncology API Market Trends,” 2023.
In summary, securing a reliable supply of niraparib tosylate involves navigating a fragmented but capable supplier landscape, emphasizing quality, regulatory adherence, and supply stability. As demand increases, strategic sourcing and proactive supplier management will be essential for stakeholders aiming to maintain continuity in cancer treatment therapies.
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