Suppliers and packagers for TIGLUTIK KIT

TIGLUTIK KIT

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

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

Suppliers and packagers for TIGLUTIK KIT

Last updated: June 6, 2026

Tiglutik Kit Suppliers and Manufacturing Sources: Who Can Supply the Drug Product and Components?

TIGLUTIK KIT is a packaged product containing riluzole oral solution for use in the management of amyotrophic lateral sclerosis (ALS). The “kit” concept is tied to the specific FDA-approved packaging and administration components for the U.S. product, which typically involve both a drug substance supply chain and packaged-drug/dispensing hardware sourced to the label.

What companies supply TIGLUTIK KIT in the U.S.?

Featured answer: The supply structure for TIGLUTIK KIT is governed by the FDA-approved labeling and the Orange Book listing for the riluzole oral solution product; the market supplier is the FDA NDA holder and its contract manufacturing/packaging network, with distributor/wholesaler channels then covering delivery to treatment sites.

What to look up on the label and Orange Book

For TIGLUTIK KIT, the commercial “supplier” question breaks into three supplier layers:

1. NDA holder / marketing authorization holder (responsible for U.S. supply under the NDA)
2. Manufacturer of record for the drug substance and drug product (GMP manufacturing)
3. Packaging/distribution partners for the kit components (vial, adapter, oral dosing device parts, and cartons labeled per the kit)

How suppliers are identified in practice

The most decision-relevant sources are:

• FDA label (package insert): lists manufacturing and packaging site language and “manufactured for” statements tied to the kit configuration.
• Orange Book (riluzole oral solution listing): identifies NDA number(s), application holder, and patent-protected NDA product.
• CGMP inspection database and enforcement actions (where available): identify additional manufacturing sites.
• Wholesaler/distributor listings: identify logistics suppliers but not IP-relevant sources.

Which manufacturers make riluzole oral solution used in TIGLUTIK KIT?

Featured answer: The underlying drug product supplier for the TIGLUTIK KIT is the GMP manufacturer that produces the approved riluzole oral solution that is then packaged into the kit configuration for distribution.

Key sourcing constraints

• Kit packaging must remain label-compliant (same dosing device/adapter configuration if included).
• Any alternative sourcing must preserve:
  • formulation integrity (riluzole stability and concentration)
  • container closure system performance
  • dosing accuracy for the labeled administration approach
  • shipping conditions and requalification of packaged components

How to map manufacturer-to-site quickly

Use:

• “Manufactured for” / “Distributed by” on the U.S. label
• FDA Drug Establishment Registration and Listing (DER&L) entries for the product
• inspection history for the labeled sites

What supplier roles exist for a “kit” drug product like TIGLUTIK KIT?

Featured answer: A kit drug product has separate supplier roles that can be sourced independently: drug product manufacturing, kit component manufacturing, and final kit assembly/packaging.

Role 1: Drug product manufacturer (bulk to finished bottle/carton)

• Produces riluzole oral solution in approved strengths
• Holds stability and validation responsibility for solution and container closure

Role 2: Kit component suppliers (if included in the package)

• Manufactures dosing hardware parts included with kit distribution
• Provides plastics/medical-grade components to match device specifications

Role 3: Final kit assembler/packager

• Assembles the kit contents exactly to the label
• Manufactures finished packaged goods and distributes under NDA quality system

Can contract manufacturers supply TIGLUTIK KIT under licensing?

Featured answer: Supply via contract manufacturing is possible when the contractor:

• produces under the NDA holder’s quality system (or through authorized contract agreements)
• passes facility and process qualification for the exact approved product presentation
• meets CGMP and labeling configuration requirements

What prevents easy resourcing

• Validation lock-in to container closure and kit administration elements
• NDA-specific manufacturing process controls
• Stability data tied to the approved packaging configuration

What generic or biosimilar-style supplier dynamics apply to TIGLUTIK KIT?

Featured answer: TIGLUTIK KIT is a small-molecule product (riluzole), so the “supplier dynamics” are driven by ANDAs and approved generics, not biosimilars.

Supplier implications

• Generic entrants typically supply their own finished dosage packaging
• Kit hardware and packaging configuration must be compatible with the approved labeling for that ANDA
• Real competition is tied to NDA/ANDA approvals, exclusivity, and patent estate rather than “kit supplier” substitution

What are the major supplier risks for downstream purchasers?

Featured answer: The main operational risks are supply continuity and packaging compliance rather than IP at the component level.

Commercial and operational risk drivers

• single-site manufacturing dependency
• constrained dosing device component supply
• change control delays for alternative packaging sources
• allocation risk during demand spikes

How does TIGLUTIK KIT supplier information differ by region?

Featured answer: In practice, suppliers vary by regulatory market based on:

• local marketing authorization holders
• local wholesalers and logistics chains
• local finished-goods packaging sites

U.S.-specific focus

For U.S. procurement and contracting, the decision-relevant “supplier” is the NDA holder and the listed manufacturing/packaging sites behind the labeled kit.

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Key Takeaways

• TIGLUTIK KIT supply depends on the FDA-approved riluzole oral solution presentation and its kit packaging configuration.
• “Suppliers” split into NDA holder, GMP drug product manufacturers, and kit assembler/packagers for label-compliant kit contents.
• Downstream procurement is most impacted by manufacturing and packaging site capacity, dosing device component availability, and label-locked packaging configurations, not by interchangeable “kit” components.

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FAQs

1) Who is the marketing authorization holder for TIGLUTIK KIT in the U.S.?

The marketing authorization holder is the NDA holder for the FDA-approved riluzole oral solution presentation sold as TIGLUTIK KIT.

2) Are TIGLUTIK KIT kit components interchangeable with other riluzole presentations?

Not without compliance to the specific labeled kit configuration and dosing method.

3) What documentation identifies TIGLUTIK KIT manufacturing sites?

The U.S. product label and FDA establishment registrations associated with the NDA product are the primary sources.

4) Can contract packers assemble TIGLUTIK KIT under an NDA?

Yes, when authorized and operating under the NDA holder’s quality system with qualified packaging and kit assembly processes.

5) What supplier issues most often cause TIGLUTIK KIT shortages?

Single-site capacity constraints, dosing component scarcity, and change-control delays tied to packaging configuration.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Labeling (TIGLUTIK KIT / riluzole oral solution package insert). U.S. Food and Drug Administration.
3. FDA. Drug Establishment Registration and Listing (DER&L). U.S. Food and Drug Administration.