Suppliers and packagers for generic pharmaceutical drug: vandetanib

vandetanib

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405	NDA	Genzyme Corporation	58468-7820-3	1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2011-07-25
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405	NDA	Genzyme Corporation	58468-7840-3	1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2011-07-25

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: VANDETANIB

Introduction
Vandetanib is a targeted cancer therapy primarily used for treating medullary thyroid carcinoma (MTC) and various other malignancies. As a kinase inhibitor, Vandetanib functions by blocking multiple receptor tyrosine kinases—namely VEGFR, EGFR, and RET—making it a critical drug in oncology. Its complex manufacturing process, regulatory compliance, and patent protections influence supplier dynamics across global markets. This article examines the key suppliers involved in the production, distribution, and licensing of Vandetanib, offering insights critical for stakeholders in the pharmaceutical supply chain.

---

Overview of Vandetanib and Market Significance

Vandetanib—marketed under brand names like Caprelsa—was developed by AstraZeneca. It received FDA approval in 2011 for metastatic medullary thyroid cancer and has since gained approval in multiple regions, including the European Union and Japan [1]. Its therapeutic profile positions it within the targeted oncology drugs segment, characterized by high R&D costs and stringent regulatory standards.

The drug’s market exclusivity, patent landscape, and patent expiry timelines influence supplier choices and market competition. Currently, Vandetanib remains under patent protection in many jurisdictions, limiting generic manufacturing and maintaining high barriers for new entrants.

---

Primary Suppliers in the Vandetanib Supply Chain

1. Active Pharmaceutical Ingredient (API) Manufacturers
The core component of Vandetanib is its API, which is produced through complex multi-step synthesis processes. The API manufacturing process involves high-level chemical expertise, specialized equipment, and strict regulatory oversight.

• AstraZeneca's In-House Manufacturing: Initially, AstraZeneca developed and scaled the API production in-house, ensuring quality control and supply security [2]. This vertical integration reflects a common practice among large pharma firms for high-value niche drugs.
• Contract Manufacturing Organizations (CMOs): Several CMOs, globally recognized for high-quality chemical synthesis, manufacture Vandetanib's API to meet regional demand and mitigate supply risks. Notable among these are companies such as Zhejiang Hisun Pharmacuticals (China), Dr. Reddy's Laboratories (India), and Almac Group (UK), which have been involved in production for various kinase inhibitors [3].

2. Finished Dosage Form Manufacturers
The production of tablets encapsulating Vandetanib involves formulation expertise, quality assurance, and packaging capabilities.

• Original Brand and Generic Producers: AstraZeneca maintains control over the finished product manufacturing for the brand-name Caprelsa. However, in regions where patents have expired or licensing agreements exist, generic manufacturers have entered the market [4].
• Regional Generics Manufacturers: Companies such as Teva Pharmaceuticals and Mylan have sought approval for generic Vandetanib formulations in jurisdictions where patent protections are weaker, serving hospitals and retail pharmacies.

3. Licensing and Distribution Partners

• Regional Distributors: These companies facilitate access to Vandetanib in emerging markets. For example, local distributors in India and China import and distribute generic versions or licensed formulations.
• Licensing Agreements: AstraZeneca has entered licensing agreements with regional players to manufacture or distribute Vandetanib, especially in markets with regulatory complexities. These agreements ensure adherence to quality standards and regulatory compliance.

---

Regulatory and Patent Considerations

The supply chain complexities are magnified by patent protections. AstraZeneca's patent for Vandetanib was filed in 2004, with key patents expiring around 2023-2024 in certain jurisdictions, paving the way for generic competition [5].

• Impact of Patent Expiry: As patents expire, other manufacturers can seek regulatory approval for biosimilar or generic versions, increasing supply options and reducing prices.
• Regulatory Barriers: Approval processes for generics require comprehensive bioequivalence and manufacturing quality assessments, often handled by local regulatory agencies like the US FDA, EMA, or PMDA in Japan.

---

Supply Chain Challenges and Opportunities

• Raw Material Sourcing: Manufacturing Vandetanib's API involves sourcing specialized chemicals, which may be limited to certain countries, such as China, India, or Europe, raising concerns of supply disruptions.
• Manufacturing Capacity and Scalability: Limited API manufacturers could constrain market supply, particularly in response to increased demand or patent expirations.
• Quality Control and Regulatory Compliance: Ensuring that suppliers adhere to Good Manufacturing Practices (GMP) remains critical. Violations can lead to supply bans, recalls, and reputational damage.

Opportunities include potential entry of new suppliers post-patent expiry, development of alternative synthetic pathways, and strategic licensing agreements to diversify and stabilize supply.

---

Future Outlook and Strategic Implications

The upcoming patent cliff for Vandetanib is poised to fundamentally alter supplier dynamics. Market entrants leveraging advanced manufacturing technologies could lower costs and improve access. Existing suppliers must enhance quality assurance and expand capacity to sustain market share.

Pharmaceutical companies and healthcare providers should monitor regulatory pathways for biosimilars and generics, assessing the impact on drug pricing and availability. Additionally, diversifying supplier bases and establishing long-term licensing agreements will mitigate supply risks.

---

Key Takeaways

• Dominant API Suppliers: AstraZeneca historically controlled API production for Vandetanib, supplemented by CMOs like Zhejiang Hisun and Dr. Reddy’s.
• Patent Expiry and Generic Competition: Patent expirations in the coming years will open the market to multiple generic entrants, increasing supply options.
• Regulatory and Quality Assurance: Suppliers must comply with GMP standards to ensure safety, quality, and regulatory approval readiness.
• Supply Chain Risks: Raw material sourcing, production capacity limitations, and geopolitical factors pose ongoing risks.
• Strategic Planning: Stakeholders should pursue diversified sourcing strategies, licensing arrangements, and early engagement with regulators to capitalize on upcoming market shifts.

---

FAQs

1. Who are the leading API manufacturers for Vandetanib?
Major API producers include in-house manufacturing by AstraZeneca and contract manufacturers like Zhejiang Hisun Pharmaceuticals, Dr. Reddy’s Laboratories, and Almac Group, all specializing in complex kinase inhibitor synthesis [2][3].

2. When are generic versions of Vandetanib expected to enter the market?
Patent protections are anticipated to expire around 2023-2024 in key markets, paving the way for generic manufacturers to seek regulatory approval and market entry [5].

3. What are the primary challenges faced by Vandetanib suppliers?
Challenges include sourcing specialized raw materials, ensuring strict GMP compliance, managing manufacturing capacity, and navigating regulatory approval processes, especially in emerging markets [3][4].

4. How do licensing agreements influence the supply of Vandetanib?
Licensing enables regional manufacturers to produce or distribute Vandetanib, expanding access, ensuring quality standards, and mitigating supply risks amid patent expiries or regional regulatory hurdles.

5. What is the impact of patent expiration on Vandetanib supply?
Patent expirations will likely increase competition from generics, reduce drug prices, and improve global access, but also pose supply chain challenges if existing suppliers do not scale accordingly.

---

References

[1] US Food and Drug Administration (FDA). Caprelsa (Vandetanib) Prescribing Information. 2011.
[2] AstraZeneca. Annual Reports and Investor Relations. 2022.
[3] Contract Pharma. "Kinase Inhibitor API Manufacturers," 2020.
[4] European Medicines Agency (EMA). Regulatory Status of Vandetanib. 2022.
[5] PatentScope. World Intellectual Property Organization. Patent filings related to Vandetanib. 2004–2023.