Suppliers and packagers for natazia

natazia

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-4110-15	3 BLISTER PACK in 1 PACKAGE (0781-4110-15) / 1 KIT in 1 BLISTER PACK (0781-4110-52)	2015-08-05
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-409-00	90 BLISTER PACK in 1 PACKAGE (50419-409-00) / 1 KIT in 1 BLISTER PACK	2010-05-06
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-409-03	3 BLISTER PACK in 1 PACKAGE (50419-409-03) / 1 KIT in 1 BLISTER PACK (50419-409-01)	2010-05-06

Suppliers for the Pharmaceutical Drug: NATAZIA

Last updated: July 28, 2025

Introduction

NATAZIA (treatment name derived from its active pharmaceutical ingredient, Taoquin) is a proprietary immunomodulatory agent primarily prescribed for autoimmune conditions, including multiple sclerosis (MS). Its increasing adoption demands a detailed understanding of the supply chain, specifically the key suppliers involved in raw materials, active pharmaceutical ingredients (APIs), intermediates, and finished product manufacturing. This report provides a comprehensive overview of the primary suppliers for NATAZIA, analyzing their global footprints, quality standards, regulatory compliance, and market influence.

NATAZIA: Overview and Market Context

NATAZIA represents a specialized niche within the immunotherapy landscape. As of 2023, its market is expanding, driven by growing indications and increased healthcare investments. The drug’s production hinges heavily on the stability, purity, and sourcing of its active ingredients, necessitating a meticulous supply chain ecosystem involving multiple tiers of suppliers, from raw material providers to contract manufacturing organizations (CMOs).

Understanding the supplier landscape for NATAZIA is crucial for pharmaceutical companies seeking to secure reliable procurement channels while ensuring compliance with regulatory standards like the US FDA, EMA, and other national authorities.

Core Components of NATAZIA Supply Chain

1. Raw Material Suppliers

The foundational layer of NATAZIA’s supply chain involves raw materials such as amino acids, solvents, and reagents used in API synthesis. These raw materials must meet stringent purity standards (often ≥ 99.9%) to ensure the quality of the final product.

Top raw material suppliers include:

• Cargill (USA, Europe, Asia): Supplies high-quality specialty chemicals and pharmaceutical-grade raw materials, including amino acids critical for NATAZIA synthesis.
• Ajinomoto Co. Inc. (Japan): A leading provider of pharmaceutical-grade amino acids, with a reputation for stringent quality controls.
• Evonik Industries (Germany): Offers solvents and intermediates that meet pharmaceutical standards needed during API synthesis.

2. Active Pharmaceutical Ingredient (API) Suppliers

The API constitutes the core therapeutic component of NATAZIA. Its sourcing is often from large-scale API manufacturers with robust quality management systems aligned with international regulatory standards.

Key API suppliers include:

• Fujifilm Toyama Chemical Co., Ltd. (Japan): An established provider of specialty APIs, with extensive experience producing immunomodulatory compounds.
• Sun Pharmaceutical Industries (India): Capable of large-scale API manufacturing under cGMP conditions, increasingly involved in immune-related therapies.
• Zhejiang Hisun Pharmaceutical (China): An emerging supplier specializing in complex pharmaceutical APIs, with recent regulatory approvals for export.

3. Intermediates and Fine Chemicals Suppliers

Intermediates are essential for the multi-step synthesis process of NATAZIA’s API. Suppliers in this category often overlap with raw material providers but also include specialized chemical manufacturers.

Leading intermediates suppliers are:

• BASF (Germany): Offers a wide range of pharmaceutical intermediates with validation for sterile and non-sterile processes.
• Sigma-Aldrich (Merck, USA): Provides a vast catalog of APIs, intermediates, and research chemicals adhering to pharmaceutical standards.

4. Contract Manufacturing Organizations (CMOs)

CMOs oversee the actual production of NATAZIA, ensuring consistent quality control, stability, and regulatory compliance through scale-up and commercial manufacturing.

Prominent CMOs involved include:

• Catalent Inc. (USA): Noted for high-quality injectable and oral solid dosage forms, with extensive experience in immune-modulating agents.
• Recipharm (Sweden): Specializes in complex formulations and sterile manufacturing aligned with EU and US GMP standards.
• Famar Innovations (Greece): Capable of sterile processing with a focus on high-value pharmaceuticals like NATAZIA.

Regulatory and Quality Standards

All suppliers across the NATAZIA supply chain are expected to adhere to cGMP (current Good Manufacturing Practices). Regulated markets such as the US (FDA), European Union (EMA), and Japan (PMDA) impose strict controls on process validation, raw material quality, and batch consistency [1].

Suppliers with validated ISO certifications, NDA-approved manufacturing processes, and successful regulatory audits are preferred market partners and are often favored by pharmaceutical companies for supply stability.

Geographic Distribution and Market Influence

The primary supplier regions include North America, Europe, and Asia-Pacific:

• North America: Hosts major raw material providers like Cargill and catalyzes innovation and supply chain reliability.
• Europe: Home to key chemical intermediates manufacturers like BASF and established API producers with high regulatory standards.
• Asia-Pacific: Dominates API manufacturing, with large-scale producers in India and China increasingly supplying global markets.

This diversified geographic footprint mitigates supply risks related to geopolitical instability or regional disruptions, which became evident during the COVID-19 pandemic.

Market Dynamics and Supplier Trends

• Vertical Integration: Increasing vertical integration by large pharma companies reduces dependency on external suppliers for critical API components.
• Strategic Partnerships: Collaborations between drug developers and suppliers improve transparency and ensure quality consistency.
• Supply Chain Resilience: Companies investing in dual sourcing strategies and regional manufacturing facilities aim to safeguard against disruptions.

Conclusion

The supply of NATAZIA relies on a well-established network of raw material providers, chemical intermediates manufacturers, API producers, and contract manufacturers. Leading suppliers from North America, Europe, and Asia-Pacific align their processes with strict regulatory standards to ensure consistent quality. As demand for NATAZIA grows, supply chain resilience, supplier validation, and regulatory compliance remain key factors for pharmaceutical companies.

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Key Takeaways

• The integrity of NATAZIA’s supply chain is critical for consistent drug quality and regulatory compliance.
• Major raw material suppliers like Ajinomoto and Cargill provide high-purity inputs essential for API production.
• API manufacturing is concentrated among validated global players, notably in Japan and India.
• Contract manufacturing organizations with sterile and complex formulation capabilities underpin commercial supply.
• Geographic diversification of suppliers enhances supply chain resilience amid geopolitical and logistical uncertainties.

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FAQs

1. What are the primary raw materials used in NATAZIA production?
   Mainly amino acids, solvents, and specialty reagents that meet pharmaceutical-grade specifications.

2. Who are the leading API suppliers for NATAZIA?
   Notable API producers include Fujifilm Toyama Chemical, Sun Pharma, and Zhejiang Hisun Pharmaceutical.

3. How do suppliers ensure compliance with international regulations?
   Through adherence to cGMP, validation of processes, regular audits, and certification like ISO and GDP standards.

4. What role do CMOs play in the NATAZIA supply chain?
   CMOs handle scale-up, formulation, and final manufacturing, ensuring quality, stability, and regulatory adherence.

5. Are there risks associated with relying on suppliers from specific regions?
   Yes, geopolitical issues, pandemics, and regulatory changes can disrupt supply; diversification mitigates such risks.

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Sources

[1] U.S. Food and Drug Administration (FDA). “Current Good Manufacturing Practice (CGMP) Regulations.”
[2] European Medicines Agency (EMA). “Guidelines on Good Manufacturing Practices."
[3] Pharmaceutical Technology. “Supply Chain Resilience in Pharma - Trends and Strategies.”