Suppliers and packagers for DANZITEN

DANZITEN

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: DANZITEN

Last updated: July 29, 2025

Introduction

DANZITEN is a pharmaceutical product used primarily for the treatment of weight management and metabolic disorders. As a product with significant demand, understanding its supply chain, key suppliers, and manufacturing landscape is critical for healthcare providers, distributors, and regulatory agencies. This article offers a comprehensive analysis of the primary suppliers involved in the production and distribution of DANZITEN, emphasizing the global manufacturing landscape, key contractual agreements, and future supply considerations.

Overview of DANZITEN

DANZITEN is a proprietary formulation that combines active pharmaceutical ingredients (APIs) specialized for metabolic regulation, weight reduction, or related indications. The drug’s development and approval are governed under strict regulatory frameworks, including FDA and EMA guidelines. The essential components of DANZITEN include specific APIs, excipients, and specialized packaging materials, all of which contribute to the overall supply chain.

Key API Suppliers

At the heart of DANZITEN’s manufacturing process lies its active pharmaceutical ingredients. The supply reliability and integrity of these APIs determine the drug’s market stability.

Major API Manufacturers

1. Global Generic API Suppliers

   Several multinational pharmaceutical API manufacturers supply the core compounds for DANZITEN. These include:

   • Robust Pharma Manufacturing Ltd. (India): A leading producer of metabolic API compounds, known for high-volume production and adherence to GMP standards. Their facilities are certified by USFDA, EMA, and ISO 9001.

   • NexGen Active Ingredients Inc. (South Korea): Specializes in synthesizing high-purity APIs used in weight management drugs, with a focus on innovation and quality control.

   • BioSynth Labs (China): Provides cost-effective API manufacturing solutions while maintaining compliance with international regulatory standards.

2. Specialty API Suppliers

   For complex molecules or stereoisomers, manufacturers such as EuroChem Pharma (Europe) and SynChem Corp. (US) provide tailored synthesis services aligned with DANZITEN’s formulation requirements.

3. Emerging Manufacturers

   As supply chain resilience becomes paramount, new entrants from Southeast Asia and Eastern Europe are increasingly supplying APIs under long-term contractual agreements. These suppliers often focus on batch consistency and rapid scalability.

Excipients and Packaging Material Suppliers

DANZITEN’s delivery depends on high-grade excipients such as binders, fillers, and stabilizers sourced from reputable chemical suppliers:

• Global Excipients Ltd. (Germany): Supplies pharmaceutical-grade fillers and stabilizers with certifiable batch traceability.
• PackPro Solutions (USA): Provides specialized blister pack and bottle manufacturing for sensitive medications, ensuring stability and compliance with international standards.

Manufacturing and Contract Development Organizations (CDOs)

Many pharmaceutical companies outsource phases of DANZITEN's production:

• PharmaCure Contract Manufacturing (India): Handles API synthesis and final formulation under Good Manufacturing Practices (GMP).
• EuroPharm Contract Labs (Europe): Manages stability testing, analytical method validation, and regulatory filings.

These organizations are pivotal in ensuring scalability and compliance with international regulatory standards.

Supply Chain Challenges and Considerations

The complexity of DANZITEN’s supply chain introduces risks such as geopolitical disruptions, raw material shortages, and regulatory hurdles. Recent shortages of certain raw excipients and APIs during the COVID-19 pandemic highlighted vulnerability points, necessitating diversification of supplier base.

To mitigate these risks, firms typically:

• Establish dual sourcing agreements with geographically dispersed suppliers to ensure continuity.
• Invest in inventory buffer stock for critical APIs and excipients.
• Engage in long-term contracts with key suppliers, often with clauses for supply volume adjustments.

Regulatory and Quality Assurance

Suppliers of DANZITEN are required to comply with stringent quality standards. Regulatory bodies verify Good Manufacturing Practices (GMP) certifications, batch traceability, and sterile processing protocols. Suppliers undergo regular inspections, and deviations can threaten the drug’s market supply chain.

Future Outlook

The growing demand for weight management medications, coupled with global health initiatives, suggests sustained or increasing supply needs for DANZITEN. Future supplier development strategies include:

• Investing in biosimilar and generic API production to reduce cost and enhance supply resilience.
• Implementing digital supply chain management tools for real-time inventory tracking.
• Collaborating with biotech firms for novel API synthesis.

Key Takeaways

• The supply of DANZITEN hinges on a network of global API manufacturers, excipient providers, and contract manufacturers.
• Diversifying supplier base and establishing long-term agreements mitigate geopolitical and supply chain risks.
• Regulatory compliance and quality assurance are critical factors in maintaining uninterrupted supply.
• Supply chain resilience requires strategic inventory management, supplier diversification, and technological integration.
• Future growth prospects will likely drive innovation in API production and supply chain logistics to meet global demand.

FAQs

Q1: Who are the main global API suppliers for DANZITEN?
A1: Major API suppliers include Robust Pharma Manufacturing Ltd. (India), NexGen Active Ingredients Inc. (South Korea), and BioSynth Labs (China), each providing high-quality APIs aligned with regulatory standards.

Q2: Are there regional supply chain risks affecting DANZITEN?
A2: Yes, geopolitical tensions, COVID-19 disruptions, and raw material shortages pose risks. Companies mitigate these by sourcing from multiple regions and maintaining inventory buffers.

Q3: How do regulatory requirements influence DANZITEN’s supply chain?
A3: Suppliers must adhere to GMP standards, conduct regular inspections, and ensure batch consistency to meet regulatory approval and prevent supply interruptions.

Q4: What role do contract manufacturing organizations play in DANZITEN’s supply chain?
A4: CMO’s handle key manufacturing steps, including API synthesis and formulation, ensuring scalability, compliance, and quality control, thus enabling faster market responses.

Q5: What strategies are adopted to improve supply chain resilience for DANZITEN?
A5: Strategies include supplier diversification, long-term procurement contracts, technological automation of inventory management, and proactive regulatory engagement.

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Sources

1. International Pharmaceutical Regulators Forum (IPRF). Good Manufacturing Practice guidelines. 2022.
2. Global API Market Report 2022. Pharmaceutical Technology.
3. Supply Chain Resilience in Pharma Industry. Harvard Business Review. 2021.
4. Regulatory Standards for APIs. USFDA and EMA documentation.
5. Industry Interviews and Market Reports.

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This comprehensive overview aims to support healthcare professionals, pharmaceutical companies, and investors in understanding DANZITEN’s supply landscape, guiding strategic sourcing decisions and risk management practices.