Suppliers and packagers for generic pharmaceutical drug: NILOTINIB TARTRATE

NILOTINIB TARTRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293	NDA	Azurity Pharmaceuticals, Inc.	24338-154-01	4 CARTON in 1 CARTON (24338-154-01) / 2 BLISTER PACK in 1 CARTON (24338-154-02) / 14 TABLET in 1 BLISTER PACK (24338-154-03)	2024-11-30
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293	NDA	Azurity Pharmaceuticals, Inc.	24338-155-01	4 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)	2024-11-30

Suppliers for the Pharmaceutical Drug: Nilotinib Tartrate

Last updated: July 29, 2025

Introduction

Nilotinib tartrate, marketed notably under brand names like Tasigna, is a potent tyrosine kinase inhibitor primarily prescribed for treating chronic myeloid leukemia (CML). As the demand for targeted cancer therapies surges globally, understanding the supply landscape of nilotinib tartrate is critical for pharmaceutical companies, healthcare providers, and investors seeking reliable sourcing channels. This article provides a comprehensive overview of the key suppliers, manufacturing dynamics, and strategic considerations associated with nilotinib tartrate.

Overview of Nilotinib Tartrate

Nilotinib belongs to the class of BCR-ABL tyrosine kinase inhibitors and specifically targets abnormal protein kinases involved in the pathogenesis of CML and Ph-positive acute lymphoblastic leukemia (ALL). The compound's commercial production involves sophisticated chemical synthesis and pharmaceutical manufacturing processes that demand high regulatory compliance and quality control standards.

Key Manufacturers and Suppliers

The supply chain for nilotinib tartrate involves a select group of pharmaceutical companies, contract manufacturing organizations (CMOs), and chemical intermediates suppliers. Their roles span from the active pharmaceutical ingredient (API) synthesis to finished product distribution.

Major Pharmaceutical Companies Producing Nilotinib Tartrate

1. Novartis AG

   As the original developer and patent holder of Tasigna, Novartis is the primary supplier of licensed nilotinib formulations globally. The company's manufacturing plants for nilotinib are situated in strategic locations, including Switzerland and the United States, adhering strictly to Good Manufacturing Practice (GMP) guidelines. Novartis supplies both branded and authorized generic versions in various markets, ensuring consistent global availability.

2. Dr. Reddy’s Laboratories

   Dr. Reddy’s has developed a robust portfolio of biosimilar and generic oncology products, including authorized generic nilotinib. The company's manufacturing facilities in India and compliance with global regulatory standards position it as a significant supplier to emerging markets. Their offerings often serve as cost-effective alternatives in regions where patent exclusivity has expired or is under threat.

3. Sun Pharmaceutical Industries Ltd.

   Sun Pharma is another prominent Indian pharmaceutical entity licensed to produce and distribute nilotinib. Their facilities have achieved WHO-GMP accreditation, and they supply both bulk APIs and finished formulations to various regions, including Asia, Africa, and Latin America.

4. Synthon BV

   Synthon specializes in developing high-quality generic drugs and has entered the nilotinib market as an authorized generic supplier. Their manufacturing is located in Europe, and they have established export channels to North America and other territories.

5. Hikma Pharmaceuticals

   Hikma produces generic oncology drugs, including nilotinib in some markets. They focus on high-quality manufacturing and global supply chain management, primarily serving Middle East, North Africa, and European markets.

Contract Manufacturing Organizations (CMOs)

Beyond brand manufacturers, several CMOs specialize in the synthesis and production of nilotinib API:

• Fresenius Kabi
  Engaged in the production of active pharmaceutical ingredients, including kinase inhibitors, with a focus on high-quality, scalable synthesis.

• Kane BioPharma
  Involved in bespoke synthesis of complex molecules, including TKIs, offering custom manufacturing solutions aligned with regulatory standards.

• Other Chinese and Indian API Suppliers

  A semi-regulated and emerging infrastructure of API intermediates suppliers from China and India supplies nilotinib raw materials to branded manufacturers and generic producers. However, quality and regulatory compliance are considerations when sourcing from these entities.

Chemical Intermediates and Raw Material Suppliers

Achieving high-grade nilotinib requires sourcing quality intermediates, such as specific amines, halogenated compounds, and chiral building blocks. Suppliers like BASF, Evonik, and local chemical vendors provide these commodities, often optimizing for cost, purity, and delivery speed.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Ensuring suppliers adhere to GMP, WHO-GMP, or FDA regulations is vital to maintain product quality and regulatory approval.

• Intellectual Property and Patent Status: As patents for nilotinib have expired in several territories, an increasing number of generic suppliers are entering the market, intensifying competition but also raising concerns regarding quality standards.

• Geographical Diversification: To mitigate risks from geopolitical or manufacturing disruptions, pharmaceutical companies typically diversify suppliers across regions such as North America, Europe, India, and China.

• Pricing and Market Dynamics: Competitive sourcing has led to price reductions, especially for generic nilotinib, impacting margins and procurement negotiations.

Emerging Trends in Nilotinib Supply

• Generic Market Expansion: As patent protections expire, the supply landscape broadens, reducing reliance on a limited number of originators and increasing marketaccess options.

• Manufacturing Advancements: Use of continuous manufacturing and process efficiencies improves scalability and cost-effectiveness.

• Quality Assurance Developments: Increased focus on supplier audits, analytical testing, and regulatory validation to prevent counterfeit or substandard products entering the supply chain.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Should establish verified supplier networks, perform due diligence, and continuously monitor regulatory compliance to maintain supply integrity.

• Healthcare Providers: Must ensure drug sourcing aligns with quality standards and consider the impact of generics on treatment outcomes.

• Investors: Need to evaluate market entrants, manufacturing capacity, and regulatory environments influencing supply stability and pricing.

Conclusion

The global supply of nilotinib tartrate encompasses a mix of original developers, licensed generics, and API manufacturers across multiple regions. As the market evolves with patent expirations and increased competition, stakeholders must prioritize quality, regulatory adherence, and supply chain resilience to ensure consistent drug availability and optimal patient outcomes.

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Key Takeaways

• Novartis remains the primary licensed supplier of nilotinib, with its manufacturing facilities supporting global distribution.

• Indian and Chinese generic manufacturers, such as Dr. Reddy’s and Sun Pharma, are key suppliers driven by patent expirations and market demand.

• Robust quality assurance, regulatory compliance, and supply chain diversification are crucial for mitigating risks.

• The expanding generic market influences pricing dynamics, with cost-effective options increasing access in emerging markets.

• Strategic sourcing and continuous monitoring of regulatory standards are vital to maintaining supply stability in this evolving landscape.

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FAQs

1. Who are the leading global suppliers of nilotinib tartrate?
Major suppliers include Novartis (original manufacturer), Dr. Reddy’s Laboratories, Sun Pharma, Synthon BV, and Hikma Pharmaceuticals, each operating across different regions and market segments.

2. Are there regional differences in sourcing nilotinib?
Yes. Developed markets predominantly access branded formulations from Novartis, while emerging markets often rely on generic versions from Indian and Chinese manufacturers.

3. What regulatory considerations should buyers of nilotinib consider?
Buyers should verify supplier compliance with GMP, WHO-GMP, or FDA standards, review manufacturing quality audits, and ensure product documentation aligns with local regulatory requirements.

4. How has patent expiry affected nilotinib's supply landscape?
Patent expiration in multiple territories has led to increased entry of generic manufacturers, expanding supply options while intensifying competition.

5. What are the future supply chain trends for nilotinib tartrate?
Expect continued expansion of generic manufacturing, adoption of advanced manufacturing techniques, and increased emphasis on supply chain security and quality assurance.

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References

1. [1] Novartis. (2022). Tasigna (Nilotinib) Prescribing Information.
2. [2] U.S. Food and Drug Administration. (2021). Orphan Drug Designations and Approvals.
3. [3] IMS Health. (2022). Global Oncology Market Trends Report.
4. [4] WHO. (2020). Guidelines on Good Manufacturing Practices.
5. [5] Indian Pharma Industry Reports. (2021). Growth and Market Analysis.