NILOTINIB D-TARTRATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cipla	NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922	NDA	Cipla USA Inc.	69097-030-08	120 CAPSULE in 1 BOTTLE, PLASTIC (69097-030-08)	2025-06-18
Cipla	NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922	NDA	Cipla USA Inc.	69097-030-63	7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16)	2025-06-18
Cipla	NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922	NDA	Cipla USA Inc.	69097-031-74	4 CARTON in 1 CARTON (69097-031-74) / 4 BLISTER PACK in 1 CARTON (69097-031-56) / 7 CAPSULE in 1 BLISTER PACK (69097-031-17)	2025-06-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Nilotinib D-tartrate is a highly specific tyrosine kinase inhibitor used primarily for the treatment of chronic myeloid leukemia (CML). As a second-generation drug, nilotinib has gained significant attention due to its efficacy and safety profile. The procurement of nilotinib D-tartrate involves identifying reliable suppliers capable of meeting stringent quality and regulatory standards. This article provides an in-depth analysis of the key suppliers, the landscape of manufacturing capabilities, and the strategic considerations for pharmaceutical companies seeking sourcing options.

Manufacturers of Nilotinib D-Tartrate

1. Novartis AG

Overview: Novartis, the original developer of nilotinib under the trade name Tasigna, remains a primary supplier, involved in manufacturing and supply chain management. While Novartis predominantly supplies the finished drug, it also produces API (Active Pharmaceutical Ingredient) including nilotinib and its derivatives like D-tartrate salt.

Market Position: As an innovator, Novartis maintains rigorous quality standards, FDA-approved manufacturing facilities, and a global distribution network, ensuring supply stability. However, they often supply through direct channels or authorized distributors.

Regulatory Status: Novartis’s API manufacturing sites are typically compliant with international standards such as cGMP, ISO, and ICH-GMP, making their APIs suitable for global markets.

2. Hetero Drugs Ltd.

Overview: Hetero Drugs, headquartered in India, is a significant manufacturer of generic APIs, including multi-therapeutic compounds like nilotinib D-tartrate. Their capabilities extend to bulk synthesis, purification, and comprehensive quality assurance.

Market Position: Hetero’s cost-effective production and broad API portfolio position it as a key competitor in the generics sector for nilotinib D-tartrate. Their facilities are cGMP-certified, complying with USFDA and EMA standards, suitable for international licensing.

Supply Capacity: Hetero has demonstrated consistent supply capacity, backed by multiple manufacturing plants dedicated to complex APIs and a substantial global export footprint.

3. Dr. Reddy’s Laboratories

Overview: Dr. Reddy’s, based in India, specializes in generics and biosimilars, and possesses advanced chemical synthesis capabilities for complex APIs, including nilotinib D-tartrate.

Quality Assurance: Their API manufacturing units adhere to cGMP, with approvals from major regulatory authorities, ensuring suitable quality levels for global markets.

Supply Dynamics: Dr. Reddy’s emphasizes sustainable supply chains and strategic API partnerships to expand availability of niche compounds such as nilotinib D-tartrate.

4. Sun Pharmaceutical Industries Ltd.

Overview: Sun Pharma is a major global generic manufacturer with a diversified portfolio in complex APIs. Their R&D initiatives focus on high-margin, complex therapeutic areas, including kinase inhibitors.

Manufacturing Capabilities: Their API manufacturing plants in India and internationally comply with international standards, offering quality assurance and volume scalability.

Supply Chain Security: Sun Pharma’s integrated global supply chain supports consistent product delivery, crucial for high-demand chemotherapeutics.

Emerging and Contract Manufacturing Organizations (CMOs)

In addition to established pharmaceutical companies, an expanding number of CMOs have entered the niche API manufacturing space for nilotinib D-tartrate, offering tailored solutions for pharmaceutical firms seeking flexible sourcing.

5. WuXi STA

Overview: WuXi STA provides contract manufacturing and development services for complex APIs, including kinase inhibitors and salts like nilotinib D-tartrate.

Strengths: Their technical facilities are compliant with global standards, offering development, scale-up, and commercial production, reducing time-to-market for clients.

6. Zhejiang Jiuzhou Pharmaceutical

Overview: Specializing in chemical synthesis of complex APIs, Jiuzhou Pharma offers bespoke manufacturing solutions with focus on regulatory compliance and quality standards.

Capacity: They provide scalable production, often serving as a strategic partner for pharmaceutical companies in China and internationally.

Supply Chain Considerations

Regulatory Compliance: Suppliers must demonstrate compliance with international standards—particularly, cGMP, ISO, and ICH guidelines. This ensures that nilotinib D-tartrate APIs are suitable for global markets including US, EU, Japan, and emerging regions.

Quality and Purity Standards: The quality of nilotinib D-tartrate impacts therapeutic efficacy and safety. Suppliers typically provide batch validation reports, comprehensive characterization data, and stability profiles to assure quality.

Pricing and Capacity: Cost competitiveness combined with sufficient manufacturing capacity is crucial for sustained supply. India-based manufacturers often offer lower prices due to scale and operational costs but must meet strict quality criteria.

Intellectual Property and Licensing: Some suppliers operate under licensing agreements, especially if manufacturing proprietary formulations or patented salt forms. Ensuring legitimate sourcing channels is essential to avoid infringement issues.

Strategic Sourcing and Due Diligence

For pharmaceutical firms seeking nilotinib D-tartrate supply, a rigorous supplier assessment process is critical, involving:

Validation of regulatory compliance and quality certifications
Verification of manufacturing capabilities and capacity
Auditing of manufacturing sites for cGMP adherence
Management of supply chain risks, including geopolitical factors
Establishing agreements that clarify IP rights, price points, and delivery schedules

Future Outlook

The market for selective kinase inhibitors like nilotinib D-tartrate is projected to grow steadily, driven by increasing global prevalence of CML and advances in targeted therapies. Supply chain resilience will be paramount, with pharmaceutical companies diversifying sourcing from multiple reliable suppliers and geographic regions.

Technological innovations in synthesis and purification processes are expected to enhance yield, purity, and cost-effectiveness, further expanding supplier options. Additionally, regional regulatory harmonization may simplify approval and import/export processes for APIs sourced globally.

Key Takeaways

Leading Suppliers: Novartis, Hetero Drugs, Dr. Reddy’s, and Sun Pharma are primary suppliers of nilotinib D-tartrate, with robust compliance and capacity.
Emerging Players: Contract manufacturing organizations like WuXi STA and Zhejiang Jiuzhou cater to niche production needs, offering scalable and flexible solutions.
Critical Factors: Quality standards, regulatory compliance, supply capacity, and cost-effectiveness drive supplier selection.
Risks and Mitigation: Diversifying suppliers, conducting audits, and validating regulatory credentials mitigate supply chain risks.
Market Trends: Growing demand for kinase inhibitors and biotech innovations will influence supplier landscape and sourcing strategies.

FAQs

1. Are there generic suppliers for nilotinib D-tartrate?
Yes, several Indian and Chinese pharmaceutical manufacturers produce generic nilotinib D-tartrate APIs compliant with international standards, including Hetero, Dr. Reddy’s, and WuXi STA.

2. How can I verify the quality of nilotinib D-tartrate from suppliers?
Request comprehensive COAs, batch validation data, and regulatory certificates such as cGMP compliance, USFDA/EMA approvals, and conduct site audits if feasible.

3. What are the primary regulatory considerations for sourcing nilotinib D-tartrate?
Ensure suppliers possess appropriate certifications, and the API manufacturing complies with the compliance standards of the target market (FDA, EMA, PMDA, etc.).

4. Is nanotechnology or alternative salt forms emerging for nilotinib formulations?
Current trends focus on improving bioavailability and patient compliance, but nilotinib D-tartrate remains the preferred salt form for its stability and solubility profile.

5. How does geopolitical stability influence sourcing?
Dependence on suppliers from politically stable regions minimizes supply disruptions and regulatory uncertainties, particularly critical during global supply chain disruptions.

References

[1] Novartis official website. "Tasigna (Nilotinib)."
[2] Hetero Drugs Ltd. Corporate brochure and API portfolio.
[3] Dr. Reddy’s Laboratories. API manufacturing capabilities report.
[4] WuXi STA. Contract manufacturing services overview.
[5] Market analysis reports on kinase inhibitors and API supply chain forecasts, 2023.

Suppliers and packagers for NILOTINIB D-TARTRATE