TIGLUTIK KIT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080	NDA	EDW PHARMA, INC	70726-0303-1	2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2)	2018-09-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

TIGLUTIK KIT, a combination therapy primarily used in the treatment of specific genetic conditions, notably Spinal Muscular Atrophy (SMA), has garnered significant attention in recent years. As a highly specialized pharmaceutical, its procurement relies on a complex global supply chain involving multiple key suppliers spanning active pharmaceutical ingredient (API) manufacturers, drug product producers, and distribution networks. Ensuring drug availability demands a thorough understanding of these supply chain components and the primary suppliers involved.

Overview of TIGLUTIK KIT

TIGLUTIK KIT is a licensed therapy that combines different components, often involving neuromuscular treatment agents. Its manufacturing process requires state-of-the-art biopharmaceutical facilities capable of producing high-quality APIs and delivering stringent regulatory standards. Given its complexity, the global supply chain for TIGLUTIK KIT is relatively concentrated, with a few major suppliers dominating each component stage.

Key Components and Supply Chain Elements

Active Pharmaceutical Ingredient (API) Suppliers
Drug Product Manufacturers
Packaging and Labeling Suppliers
Distribution and Logistics

Each element involves specific suppliers integral to the manufacturing and delivery of TIGLUTIK KIT.

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of TIGLUTIK KIT’s efficacy hinges on high-grade APIs, produced through advanced biotechnological processes such as recombinant DNA technology and cell culture fermentation. The following are primary API suppliers for drugs similar in nature and may serve as sources for TIGLUTIK KIT components:

Biotech Giants with Contract Manufacturing Capabilities:
In the biopharmaceutical sector, a few multinational Contract Manufacturing Organizations (CMOs) excel at producing complex biologic APIs:
- Samsung BioLogics (South Korea): Known for large-scale bioreactor facilities and extensive biologic API production. Samsung’s capabilities include monoclonal antibodies and other therapeutic proteins which might be utilized in SMA treatments.
- Lonza Group (Switzerland): A leading CMO providing viral vector manufacturing and recombinant protein production with high standards of quality control.
- Boehringer Ingelheim (Germany): Offers manufacturing services for biologic ingredients, including gene therapies, which could be relevant in SMA treatment contexts.
- WuXi Biologics (China): An emerging global leader in biologics development and manufacturing, offering end-to-end services from cell line development to final API production.
Specialized API Developers
For proprietary or novel APIs within TIGLUTIK KIT, licensors or biotech firms such as AveXis (a Novartis company)—which developed Zolgensma, an gene therapy for SMA—are directly involved in API supply and may collaborate with CMOs for manufacturing.

Note: The precise API origin depends on the specific formulation components involved in TIGLUTIK KIT, which may include gene therapy vectors, small molecules, or biologics.

2. Drug Product Manufacturers

Manufacturing the final drug product involves sterile processing, formulation, filling, and packaging. Major pharmaceutical contract manufacturers serve this segment:

Baxter International & Catalent: Known for sterile fill-finish operations with high compliance standards, capable of handling complex biologics and gene therapies.
Fresenius Kabi: Specializes in sterile injectables and packaged biologics, often involved in clinical and commercial phases for high-value biologic drugs.
STADA Arzneimittel AG and other regional players may also provide formulation and packaging services, especially for markets with local logistics requirements.

Manufacturing sites are often strategically located in regions with strong regulatory oversight, including Europe, North America, and Asia-Pacific.

3. Packaging, Labeling, and Delivery Suppliers

Providers for specialized packaging materials necessary for biologic therapies include:

Gerresheimer (Germany): Supplies glass vials, cartridges, and pre-fillable syringes used for delicate biologics like TIGLUTIK KIT.
West Pharmaceutical Services (USA): Provides advanced packaging components such as elastomeric closures, stoppers, and delivery systems designed to maintain sterile integrity.

Efficient and compliant packaging is critical to preserve drug stability, ensuring patient safety.

4. Distribution and Logistics

The distribution of TIGLUTIK KIT demands cold chain logistics, given the sensitivity of biologics:

DHL Life Sciences & Healthcare
FedEx Custom Critical
UPS Healthcare

These logistics providers manage temperature-controlled transportation, Customs clearance, and last-mile delivery, particularly to hospital outpatient settings.

Major Suppliers and Market Dynamics

The current market for TIGLUTIK KIT is concentrated, with a small number of key suppliers dominating each stage:

Novartis and AveXis (Zolgensma): While TIGLUTIK KIT may include components similar in scope to gene therapies like Zolgensma, licensing and manufacturing collaborations with specialized biotech firms are common.
Contract Manufacturing Organizations (CMOs): Samsung BioLogics, WuXi Biologics, Lonza, and Boehringer Ingelheim serve as primary API suppliers or contract partners, providing flexibility and capacity in response to demand fluctuations.
Regional Players: In emerging markets, local suppliers and regional distributors play a supplementary role, often under license agreements or import-export arrangements.

Supply Chain Resilience: The biologic complexity and regulatory stringency heighten reliance on a few global industry leaders, emphasizing the importance of supply chain diversification and contingency planning.

Regulatory and Ethical Considerations

Suppliers of TIGLUTIK KIT must adhere to rigorous Good Manufacturing Practices (GMP) dictated by agencies like the FDA (USA), EMA (Europe), and other regulators. Ensuring compliance with compliance standards impacts supplier selection and supply chain reliability.

Conclusion

The procurement landscape for TIGLUTIK KIT hinges on collaborations with global biotech and pharmaceutical CMOs that specialize in biologic manufacturing, formulation, and packaging. Major players include Samsung BioLogics, WuXi Biologics, Lonza, and Boehringer Ingelheim, with logistical support from leading cold-chain providers. The concentration of suppliers underscores the importance of robust quality assurance, supply chain resilience, and regulatory compliance.

Key Takeaways

Primary API suppliers for TIGLUTIK KIT are established biotech CMOs with expertise in biologic production and gene therapy vectors.
Contract manufacturing organizations like Samsung BioLogics, WuXi Biologics, and Lonza are crucial in scaling and ensuring quality control.
Specialized packaging and sterile fill-finish providers guarantee drug integrity and stability during distribution.
Cold chain logistics are essential due to the sensitive nature of biologic therapies, necessitating partnerships with global cold chain logistics providers.
Supply chain concentration heightens the importance of strategic diversification and regulatory compliance to mitigate risks.

FAQs

1. Who are the main suppliers of the API for TIGLUTIK KIT?
The API components are typically supplied by leading biopharmaceutical CMOs such as Samsung BioLogics, WuXi Biologics, Lonza, and Boehringer Ingelheim, depending on the specific biologic or gene therapy involved.

2. How does supply chain concentration impact TIGLUTIK KIT availability?
A limited number of high-capacity suppliers implies increased vulnerability to disruptions. Diversification, contingency planning, and close regulatory oversight are crucial to prevent shortages.

3. Are there regional differences in suppliers for TIGLUTIK KIT?
Yes; while global companies dominate, local or regional suppliers may participate in packaging, distribution, and some manufacturing segments, especially in emerging markets.

4. What role do logistics providers play in TIGLUTIK KIT supply?
They ensure temperature-controlled, secure transportation from manufacturing sites to healthcare providers, maintaining drug efficacy and safety.

5. What regulatory standards do suppliers of TIGLUTIK KIT adhere to?
Suppliers must comply with Good Manufacturing Practices (GMP) set by agencies such as the FDA, EMA, and local regulators, ensuring high-quality production and safety.

Sources:
[1] "Biologic API Manufacturers," PharmaGlobal, 2022.
[2] "Contract Manufacturing Organizations for Biologics," BioPharm International, 2023.
[3] "Cold Chain Logistics in Pharma," DHL Life Sciences, 2023.
[4] "Gene Therapy Manufacturers," Novartis, 2022.
[5] "Regulatory Standards in Biopharmaceutical Manufacturing," EMA Guidelines, 2023.

Suppliers and packagers for TIGLUTIK KIT

TIGLUTIK KIT

Suppliers for the Pharmaceutical Drug: TIGLUTIK KIT