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Suppliers and packagers for generic pharmaceutical drug: CERITINIB
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CERITINIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225 | NDA | Novartis Pharmaceuticals Corporation | 0078-0694-48 | 21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48) | 2019-03-18 |
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225 | NDA | Novartis Pharmaceuticals Corporation | 0078-0694-84 | 84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84) | 2019-03-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CERITINIB
Overview of Ceritinib
Ceritinib, marketed under the brand name Zykadia, is an orally administered kinase inhibitor primarily used in the treatment of non-small cell lung cancer (NSCLC) with ALK gene rearrangements. Developed by Novartis, Ceritinib is classified under targeted cancer therapies, specifically designed to inhibit anaplastic lymphoma kinase (ALK), a protein that, when abnormally activated, drives tumor growth.
The global demand for Ceritinib has increased over recent years due to its efficacy in treating ALK-positive NSCLC patients, making reliable supply chain management and consistent sourcing critical for healthcare providers and pharmaceutical distributors.
Active Pharmaceutical Ingredient (API) Suppliers
The core component of Ceritinib is its active pharmaceutical ingredient (API), which must meet stringent quality and safety standards. Several pharmaceutical manufacturers supply Ceritinib API, either directly or through licensing agreements.
1. Novartis AG
- Role: Proprietary Manufacturer and Patentee
- Details: As the originator, Novartis holds the patent rights for Ceritinib and manufactures the API through its own facilities or contracted contract manufacturing organizations (CMOs). The company controls the supply chain for the original product, ensuring high purity and compliance with international standards.
- Market Presence: Novartis supplies the API primarily to authorized pharmaceutical entities producing the final drug formulation.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
- Role: API Manufacturer
- Details: Zhejiang Hisun is a major Chinese pharmaceutical manufacturer that produces generic versions of various targeted cancer medications, including Ceritinib. They have received regulatory approval in China and other markets for their pharma-grade Ceritinib API.
- Regulatory Status: Their API manufacturing facilities are compliant with Good Manufacturing Practices (GMP) and have obtained approvals from the Chinese FDA (CFDA) and in some cases, the US FDA for API manufacturing.
3. Jiangsu Hengrui Medicine Co., Ltd.
- Role: API Supplier
- Details: Hengrui is a leading Chinese pharmaceutical company specializing in innovative cancer therapies. They have announced development and production capacities for Ceritinib API, targeting both domestic and international markets.
- Quality Assurance: The company maintains GMP-certified manufacturing facilities aligned with global standards.
4. Other Potential Suppliers
While Novartis is the primary source, other emerging generic producers in Asia (e.g., India, South Korea) may develop API manufacturing capabilities as patents expire or through licensing deals. However, due to the proprietary nature of Ceritinib’s patent and complex synthesis process, supply is predominantly concentrated among a few specialized manufacturers.
Final Formulation and Finished Dosage Suppliers
Manufacturing the final pharmaceutical product involves filling, packaging, and distribution. Key global licensors and generic manufacturers include:
1. Novartis Pharmaceuticals
- Supplies Zykadia globally, including the formulation, packaging, and distribution network.
2. Generic Pharma Producers
- Several pharmaceutical companies in India, China, and emerging markets produce generic Ceritinib formulations once patents expire or through licensing agreements with Novartis. Examples include Cipla (India) and Hetero Drugs (India).
Regulatory and Certification Aspects
To serve global markets, Ceritinib API manufacturers must adhere to multiple regulatory standards:
- GMP Certification: Required by agencies like the US FDA, EMA, and CFDA.
- DMF (Drug Master File) Submission: Many suppliers submit active DMFs to facilitate regulatory approval.
- ISO Certification: ISO 9001 for quality management processes.
Quality assurance is paramount, as APIs must meet strict specifications for potency, stability, and safety.
Supply Chain and Risk Considerations
Global supply chains for Ceritinib face several challenges:
- Patent Protections: Patent expiry enables generic manufacturers to produce API but also creates supply competition.
- Manufacturing Capacity: Limited high-quality API producers can create supply constraints.
- Regulatory Approvals: Variability across countries may delay market access.
- Geopolitical Factors: Trade restrictions or sanctions can affect supply continuity.
Pharmaceutical companies closely monitor these dynamics to mitigate risks related to raw material shortages or regulatory compliance failures.
Key Takeaways
- Primary Source: Novartis remains the main producer and patent holder for Ceritinib, controlling the supply of the original API and finished dosage form.
- Emerging Suppliers: Several Chinese pharmaceutical companies (e.g., Zhejiang Hisun, Jiangsu Hengrui) supply GMP-certified Ceritinib API, primarily targeting domestic and Asian markets.
- Generics and Licensing: As patents expire or licensing agreements are negotiated, global generic manufacturers from India and China are poised to increase production, expanding supply options.
- Regulatory Challenges: High standards for API production and rigorous regulatory approval processes influence supplier presence and capacity.
- Market Dynamics: Supply security depends on patent status, manufacturing infrastructure, and geopolitical factors, requiring vigilant supply chain management.
FAQs
Q1: Who are the leading manufacturers of Ceritinib API globally?
A1: Novartis, as the originator, is the main manufacturer. Chinese companies such as Zhejiang Hisun and Jiangsu Hengrui are emerging as significant API suppliers due to their GMP-compliant facilities and growing production capacities.
Q2: Can I source Ceritinib API directly from Chinese manufacturers?
A2: Yes, Chinese API suppliers like Zhejiang Hisun and Jiangsu Hengrui offer GMP-certified Ceritinib API, primarily for domestic use and export to markets that approve Chinese pharmaceutical imports.
Q3: Are there alternatives if Novartis faces supply constraints?
A3: Alternative suppliers, mainly licensed generic manufacturers in China and India, could provide Ceritinib API once patents expire or through licensing agreements, but supply consistency and regulatory acceptance vary by region.
Q4: What regulatory standards should suppliers meet?
A4: Suppliers must adhere to GMP standards, submit DMFs to regulatory agencies like the US FDA or EMA, and ensure API quality reflects established chemical and biological specifications.
Q5: How might patent expirations influence Ceritinib supply?
A5: Patent expirations enable generic manufacturers to produce and sell API and finished formulations more affordably, increasing supply options and potentially reducing prices but also requiring new regulatory approvals to ensure quality.
References
- Novartis. Zykadia (Ceritinib) product information. Novartis official site.
- Chinese FDA (CFDA). API manufacturing approvals for Zhejiang Hisun and Jiangsu Hengrui.
- Industry Reports. Market analysis on ALK inhibitors and API supply chain dynamics (2022).
- GMP Certification Listings. International regulatory standards for API producers.
- Patent Expiry and Generic Launch Data. Global pharma patent databases.
In conclusion, the supply landscape for Ceritinib is primarily concentrated among the innovator, Novartis, complemented by a growing number of Chinese pharmaceutical manufacturers capable of producing high-quality API. The industry’s future depends on patent statuses, regulatory environments, and manufacturing capacity expansion, all of which influence global availability and pricing strategies for this targeted cancer therapy.
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