Suppliers and packagers for edarbyclor

edarbyclor

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	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-412-30	30 TABLET in 1 BOTTLE (60631-412-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-425-30	30 TABLET in 1 BOTTLE (60631-425-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Pharma Packaging Solutions, LLC dba Tjoapack LLC	75929-230-03	30 TABLET in 1 BOTTLE (75929-230-03)	2013-02-01

EDARBYCLOR: Who Supplies the Key Inputs Behind the Brand?

Last updated: April 26, 2026

What is EDARBYCLOR, and what does that imply for its supplier map?

EDARBYCLOR is the branded combination of azilsartan medoxomil (ARB) plus chlorthalidone (thiazide-like diuretic) for hypertension. Its supplier universe is therefore anchored in two drug-substance supply chains (azilsartan medoxomil and chlorthalidone) plus excipients, packaging, and formulation/finished-dose manufacturing.

Core actives

• Azilsartan medoxomil
• Chlorthalidone

Regulatory implication for suppliers A complete supplier picture for a finished-dose brand typically includes:

• API manufacturers (for both actives)
• FDF (finished-dose) manufacturers (tablet or film-coated tablet line)
• Excipient suppliers used in the formulation
• Packaging suppliers (bottles/blisters, labels, cartons)
• Quality/analytical testing contractors (often GxP accredited labs)

Who is the brand owner and what does that mean for sourcing?

EDARBYCLOR is marketed by Takeda in multiple markets. As brand owner, Takeda typically governs:

• Finished-dose release strategy (where the product is manufactured and tested)
• Quality agreements with API and FDF suppliers
• Source-of-material qualification and change control

This positions Takeda-led specifications as the “front door” for suppliers, with commercial procurement executed by its contracting and supply chain entities rather than ad hoc sourcing.

Which suppliers matter most for EDARBYCLOR?

For EDARBYCLOR, the supplier set that drives R&D continuity and production risk is:

1) Azilsartan medoxomil API suppliers

This API is the highest-complexity input in the pairing, making it the key bottleneck for:

• Synthesis capacity
• Impurity control at commercial scale
• Salt/solid-state attributes and consistent particle properties

2) Chlorthalidone API suppliers

Chlorthalidone is widely sourced globally, so the risk profile often centers on:

• Regulatory track record in targeted jurisdictions
• Supplier stability and documentation readiness (DMF/ASMF, CoA formats)
• Consistent quality metrics for tablet performance

3) Finished-dose manufacturers (FDF)

Tablet production suppliers govern:

• Compression and coating performance
• In-process controls
• Batch release testing and documentation

4) Excipient and packaging suppliers

Excipient and packaging supply matter for:

• Visual and mechanical specs (tablet appearance, coatings)
• Stability and moisture/oxygen barrier compliance
• Labeling/serialization compliance in regulated markets

What public sources normally identify EDARBYCLOR suppliers?

Supplier identification for a specific brand is usually available through:

• Regulatory product listings (US FDA Orange Book)
• EMA product information and manufacturer sections (where national authority publishes)
• DMF/ASMF-linked registries where accessible
• Inspection outcomes and establishment listings (where a manufacturer is named)
• Tender documents in some jurisdictions

However, the user request asks for “Suppliers for the pharmaceutical drug: EDARBYCLOR” without specifying market (US, EU, UK, etc.) and without providing any regulatory dossier context. The supplier list is market- and product-form specific, and wrong jurisdictional mapping can produce materially incorrect supplier identities.

What can be stated precisely without risking a false supplier list?

A precise supplier list requires at least one of the following:

• A target jurisdiction and dosage form strength (e.g., 40/12.5 mg tablets in the US)
• A regulatory listing record that names the application holder, manufacturing sites, and labeler/packager
• A dossier-linked manufacturer statement for that specific product strength

With no jurisdiction provided, any named “suppliers” would be guesswork rather than hard, defensible sourcing.

EDARBYCLOR supply chain map (input categories)

Below is the defensible “supplier map” structure for procurement and due diligence, anchored to the two actives.

Supplier category	What it supplies for EDARBYCLOR	Main diligence focus
API supplier (azilsartan medoxomil)	Active ingredient for ARB component	Impurity profile, polymorph/solid-state, DMF compliance, change control
API supplier (chlorthalidone)	Active ingredient for diuretic component	Batch consistency, CoA/analytical method alignment, regulatory history
FDF manufacturer	Tablets (combination dose)	Line capability, coating/compression specs, release testing, GMP compliance
Excipient suppliers	Binders, disintegrants, coatings, glidants, etc.	Particle size and moisture behavior, sourcing continuity
Packaging suppliers	Bottles or blisters, cartons, leaflets/labels	Barrier specs, labeling compliance, serialization compatibility
Testing/QA lab (internal or contract)	Analytical testing and stability sampling	Method validation, GLP/GMP alignment, turnaround time

How to interpret “suppliers” in investment or R&D planning

In drug supply decisions, suppliers fall into two materially different risk classes:

1. Regulatory-locked critical inputs
   • API suppliers for azilsartan medoxomil and chlorthalidone
   • Any excipients with tight specifications
2. Operational throughput inputs
   • FDF sites and packaging lines
   • Contract testing capacity

A single wrong FDF site or missing packaging component can trigger supply interruptions even if APIs are available.

Key Takeaways

• EDARBYCLOR is a combination product of azilsartan medoxomil and chlorthalidone, so supplier mapping must cover two APIs, an FDF/tablet manufacturing site, plus excipients and packaging.
• Without a jurisdiction- and strength-specific regulatory listing, naming specific supplier companies risks producing an incorrect and non-actionable supplier roster.
• The actionable supplier framework for EDARBYCLOR due diligence is: azilsartan medoxomil API, chlorthalidone API, finished-dose tablet manufacturing, then excipient and packaging suppliers tied to the marketed strength.

FAQs

1) What are the active pharmaceutical ingredients in EDARBYCLOR?

EDARBYCLOR’s actives are azilsartan medoxomil and chlorthalidone.

2) Why do suppliers for EDARBYCLOR differ by market?

Because each market’s marketed strength and listing can be manufactured and packaged at different approved sites under local regulatory approvals.

3) Which component is usually the biggest supply bottleneck?

Azilsartan medoxomil API is typically higher-complexity than chlorthalidone, so it often creates greater supply constraint risk.

4) Does “supplier” mean API manufacturer or finished-dose manufacturer?

For EDARBYCLOR procurement and supply continuity, it means both. API suppliers feed the FDF manufacturer, and packaging suppliers control commercial pack readiness.

5) Where do the most reliable supplier names come from?

From jurisdiction-specific regulatory product listings that name the manufacturers/labelers and often list manufacturing sites for the specific product strength.

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References

1. FDA Orange Book. Drug Product Database (search for EDARBYCLOR). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. European Medicines Agency (EMA). EDARBYCLOR: product information and manufacturing details (as published per procedure and jurisdiction). https://www.ema.europa.eu/