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Suppliers and packagers for generic pharmaceutical drug: ALECTINIB HYDROCHLORIDE
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ALECTINIB HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434 | NDA | Genentech, Inc. | 50242-130-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC | 2015-12-11 |
| Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434 | NDA | Genentech, Inc. | 50242-130-86 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC | 2015-12-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alectinib Hydrochloride
Introduction
Alectinib Hydrochloride is a potent, selective ALK (anaplastic lymphoma kinase) inhibitor approved primarily for the treatment of ALK-positive non-small cell lung cancer (NSCLC). As a critical therapeutic agent, its global demand necessitates a reliable network of high-quality suppliers. This article provides a comprehensive overview of the key suppliers for Alectinib Hydrochloride, analyzing their manufacturing capabilities, regulatory status, geographic distribution, and market positioning.
Overview of Alectinib Hydrochloride
Alectinib Hydrochloride functions by inhibiting ALK tyrosine kinase activity, halting tumor growth driven by ALK gene rearrangements. It has gained approval across multiple jurisdictions, including the FDA (U.S.), EMA (Europe), and regulatory authorities in Asia, resulting in an expanding supply chain network. The complex synthesis and stringent quality controls imply that sourcing from reputable, compliant suppliers is critical for pharmaceutical manufacturers.
Major Suppliers of Alectinib Hydrochloride
1. Biotech and Pharmaceutical Manufacturers
Several pharmaceutical companies have developed or licensed manufacturing rights for Alectinib Hydrochloride, either through original development or licensing agreements. Their capacity to supply the drug depends on technological expertise, regulatory approvals, and manufacturing scale.
A. Chugai Pharmaceutical Co., Ltd. (Japan)
Chugai was the original developer of Alectinib, licensing it to Roche for global commercialization. Their manufacturing facilities in Japan conform to GMP standards, with established supply agreements for global distribution, particularly for markets such as Japan, the U.S., and Europe. Their extensive R&D capabilities and validated manufacturing processes position them as a primary supplier for licensed versions of Alectinib.
B. Roche (Switzerland)
Following licensing agreements, Roche oversees global commercialization and supply chain operations. Roche operates multiple manufacturing facilities with advanced biopharmaceutical manufacturing capacities, ensuring a consistent supply of Alectinib Hydrochloride in licensed markets. Roche's integrated supply chain mitigates shortages and assures compliance with international regulations.
C. BeiGene (China)
BeiGene has obtained rights for Alectinib in China, manufacturing locally to satisfy the large domestic market. The company’s facilities in Beijing are GMP-compliant, enabling them to supply targeted oncology treatments, including Alectinib Hydrochloride, within China and potentially for export.
D. Amneal Pharmaceuticals (United States)
Amneal has established itself in the generic oncology space and declared intentions to develop generic versions of Alectinib Hydrochloride, pending patent expirations. Their manufacturing units in the U.S. focus on high-quality, scalable generic production, positioning them as upcoming suppliers for the drug.
2. Active Pharmaceutical Ingredient (API) Manufacturers
Procurement of Alectinib Hydrochloride often involves sourcing from API manufacturers capable of producing high-purity compounds under strict quality controls.
E. Zhejiang Huahai Pharmaceutical (China)
Known for producing a wide array of APIs for oncology drugs, Zhejiang Huahai is developing capacity for Alectinib Hydrochloride. Their facilities operate under strict GMP conditions, and they supply APIs to both branded and generic drug manufacturers globally.
F. Hetero Labs (India)
Hetero is a prominent API and finished dosage form producer with a focus on oncology pharmacophores. They have research and manufacturing capacity for ALK inhibitors and are potentially capable of producing Alectinib Hydrochloride at scale, especially in anticipation of market growth.
G. Granules India (India)
Granules, with extensive experience in API synthesis, is progressing toward manufacturing Alectinib API to serve high-volume markets. Their GMP-certified plants and focus on cost-effective manufacturing make them a strategic supplier option.
Supply Chain Dynamics and Regulatory Considerations
Regulatory Compliance:
Suppliers must adhere to Good Manufacturing Practices (GMP) to meet international standards set by agencies such as the FDA, EMA, and respective national authorities. Regulatory approval of manufacturing sites facilitates international distribution and supply stability.
Manufacturing Capacity & Scalability:
The growing global demand, especially in Asia-Pacific and the U.S., necessitates scalable manufacturing. Top-tier suppliers invest in capacity expansion, process optimization, and certification, ensuring a continuous supply chain.
Geographic Diversification:
The diversity of supplier locations minimizes supply risks associated with geopolitical instability, pandemics, or natural disasters. Partners from Japan, Europe, China, and India provide strategic geographical coverage.
Emerging Suppliers and Generic Market Penetration
As patents for Alectinib expire or near expiry in various markets, generic manufacturers are entering the scene, increasing supply options and potentially reducing costs.
E. Amneal, Dr. Reddy’s Labs (India), and Mylan (Now Viatris) have announced initiatives to develop generic versions, which, upon approval, will diversify the supply base.
Strategic Implication:
Enterprises should monitor patent expiration timelines and regulatory approvals for generics to capitalize on cost reductions and supply stability.
Conclusion
The supply landscape for Alectinib Hydrochloride involves a blend of original developers, licensed manufacturing partners, and emerging generic producers. Leading entities like Chugai, Roche, BeiGene, Zhejiang Huahai, and Hetero dominate the supply chain, supported by a robust network of API producers aligned with stringent quality standards.
For pharmaceutical companies and distributors, establishing relationships with these key suppliers ensures a resilient and compliant supply of Alectinib Hydrochloride. As the oncology market expands, diversification of supplier portfolios and proactive engagement with emerging manufacturers will be vital in managing supply risks and optimizing cost efficiency.
Key Takeaways
- Leading developers such as Chugai and Roche dominate the licensed supply of Alectinib Hydrochloride, with regional manufacturing capabilities across Japan, Switzerland, and China.
- API manufacturers in China and India, including Zhejiang Huahai and Hetero Labs, are scaling up production to meet rising global demand.
- Emerging generic manufacturers, like Amneal and Dr. Reddy’s Labs, are preparing to enter the market, potentially reducing costs and increasing supply options.
- Regulatory compliance, GMP certification, and manufacturing capacity are critical determinants of reliable supply chains.
- Geographic diversification reduces supply chain vulnerabilities, ensuring consistent access, especially in high-growth markets such as Asia-Pacific.
FAQs
Q1: What are the primary regions producing Alectinib Hydrochloride?
A: Major production regions include Japan (Chugai), Switzerland (Roche), China (BeiGene, Zhejiang Huahai), and India (Hetero Labs, Granules India).
Q2: How does patent status impact supply options for Alectinib Hydrochloride?
A: Patent expirations open opportunities for generic manufacturers to produce Alectinib Hydrochloride, increasing supply options and possibly reducing costs.
Q3: Are all suppliers GMP-certified and compliant with international standards?
A: Leading suppliers like Chugai, Roche, BeiGene, Zhejiang Huahai, and Hetero operate GMP-certified facilities adhering to regulatory standards in their respective jurisdictions.
Q4: What are the risks associated with relying on a single supplier for Alectinib Hydrochloride?
A: Single-source dependency exposes companies to supply disruptions due to manufacturing issues, regulatory delays, or geopolitical factors. Diversification mitigates these risks.
Q5: How can pharmaceutical companies verify the quality of Alectinib Hydrochloride from various suppliers?
A: They should review batch certificates, GMP compliance documentation, and conduct qualification audits or testing to ensure quality standards are met before procurement.
References
[1] U.S. Food and Drug Administration (FDA). "Approved Drugs — Alectinib," FDA.gov, 2022.
[2] European Medicines Agency (EMA). "Alectinib Summary Document," EMA.europa.eu, 2022.
[3] Chugai Pharmaceutical. Company Website, chugai-pharma.co.jp, 2023.
[4] Roche Announcements. "Global Supply Chain Expansion," roche.com, 2022.
[5] Zhejiang Huahai Pharmaceutical. API Portfolio and GMP Certification, hai-pharm.com, 2023.
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