AZILSARTAN MEDOXOMIL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489	ANDA	Lupin Pharmaceuticals, Inc.	70748-236-06	30 TABLET in 1 BOTTLE (70748-236-06)	2026-05-14
Lupin	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489	ANDA	Lupin Pharmaceuticals, Inc.	70748-237-06	30 TABLET in 1 BOTTLE (70748-237-06)	2026-05-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 18, 2026

Azilsartan medoxomil supply is split across (1) API and key intermediates, (2) formulation component supply (excipients and film-coating materials), and (3) contract manufacturing services for solid oral dosage forms. The practical supplier map depends on whether the procurement target is original-brand finished product supply, generic API supply, or custom contract manufacturing for tablets/capsules.

What companies supply azilsartan medoxomil API?

Featured snippet answer: Supplier identification for azilsartan medoxomil API is typically handled via (a) DMFs for U.S. FDA listing, (b) global pharmaceutical supply databases, and (c) direct commercial outreach to API producers and intermediate manufacturers.

What to look for in azilsartan medoxomil API sourcing

Azilsartan medoxomil is an ester prodrug of azilsartan (ARB). Contract and licensing procurement focuses on three supply tiers:

Tier 1: API manufacturers with regulatory dossiers

Firms filing or referencing FDA Drug Master Files (DMFs) for the API or key intermediates
Manufacturers supplying to generic or branded finished-dose plants under long-term supply agreements

Tier 2: Key intermediate producers

Azilsartan medoxomil API supply chains commonly require intermediate chemical synthesis steps. Procurement focuses on:

Availability of drug-substance intermediates with consistent impurity profiles
Ability to support required specs and stability data for intermediates

Tier 3: Custom synthesis and scale-up CMOs

For developers and generic manufacturers, common options include:

Process R&D and scale-up via chemistry CMOs
Technology transfer support to a tablet plant

What listings and documents usually identify suppliers

U.S. FDA DMF index (API and intermediate DMFs)
European drug substance registration dossiers (where applicable)
Supplier qualification packs: COA, impurity panels, residual solvent compliance, and particle size controls for downstream granulation

Which contract manufacturers make azilsartan medoxomil tablets (solid oral dosage forms)?

Featured snippet answer: Tablets are the dominant commercial dosage form for azilsartan medoxomil, and CMOs that support oral solids typically run azilsartan medoxomil tablets under:

Direct compression or wet granulation flows
Film coating with HPMC-based or similar systems
Packaging formats such as bottles and unit-dose blisters, depending on market

What CMO capabilities matter for azilsartan medoxomil

Key selection criteria for procurement teams:

Analytical method transfer capability for assay, related substances, and dissolution
Scale-up experience for similar ARB prodrugs (handling of ester-containing actives)
Stability program support for intermediate and finished product
Ability to meet ICH Q3A/Q3B impurity and residual solvent limits

What manufacturing formats are typically sourced

Strength-specific tablet builds (API loading drives feasibility and blend uniformity)
Coating and embossing requirements for market-specific presentation
Tight control of polymorphism or crystallinity if relevant to local development

What excipient and film-coating suppliers are used for azilsartan medoxomil products?

Featured snippet answer: Excipients for azilsartan medoxomil tablets are sourced from large, qualified excipient vendors and are selected based on compendial status and compatibility with prodrug stability.

Common excipient classes used in oral tablets

Procurement usually targets suppliers that can provide:

Tablet diluents (e.g., microcrystalline cellulose grades)
Binders (e.g., povidone or HPMC grades)
Disintegrants (e.g., croscarmellose sodium or similar)
Lubricants (e.g., magnesium stearate, stearic acid grades)
Film coating polymers (e.g., HPMC-based systems) and plasticizers
Colorants or imprint technologies where required

What procurement teams validate

CoA and incoming quality
Particle size distributions for blend uniformity
Low impurity profiles (especially for catalysts and heavy metals)
Stability data aligned with the drug product stability program

Which azilsartan medoxomil intermediates are critical to supplier continuity?

Featured snippet answer: Supplier continuity risk is concentrated in key chemical intermediates used for esterification and prodrug assembly steps, plus intermediates governing impurity levels.

Why intermediate supply matters

Azilsartan medoxomil API is sensitive to:

Process impurity carryover
Residual solvent and reagent controls
Batch-to-batch impurity drift during scale-up

Procurement tactics used to reduce risk

Dual sourcing of critical intermediates
Qualification acceptance based on impurity mapping rather than only assay
Buffer stock or multi-quarter committed supply for GMP-graded intermediates

What generic azilsartan medoxomil suppliers compete in the market?

Featured snippet answer: Generic competition depends on product approvals and local commercialization networks. Supplier identity for generic finished dose is often tied to the ANDA sponsor and the manufacturing site listed for each product.

What to check for a “generic supplier” view

For each strength and NDC:

ANDA applicant and listed manufacturer
Drug substance source listed in CMC submissions
Contract manufacturer identity for oral solid manufacturing

What sourcing barriers affect azilsartan medoxomil API and tablet supply?

Featured snippet answer: The biggest barriers are regulatory dossier availability (DMF), impurity controls, and long qualification timelines for oral solid manufacturing.

Regulatory and quality barriers

DMF access or cross-reference agreements
Need for process validation and method validation prior to launch
Stability and accelerated testing capacity

Commercial barriers

Lead times for packaging and coating supplies
Dependence on a small number of qualified tablet plants for specific strengths

How does azilsartan medoxomil supplier coverage compare with other ARBs (e.g., telmisartan, valsartan)?

Featured snippet answer: Compared with heavily commoditized ARBs, azilsartan medoxomil can have fewer established API supply chains because demand and dossier concentration are lower.

Practical procurement implication

ARB sourcing strategy often relies on a small set of API and CMO ecosystems
Dual sourcing becomes more critical for niche ARB prodrugs

Key Takeaways

Azilsartan medoxomil supply is organized across API producers, intermediate makers, and solid oral tablet CMOs.
Supplier qualification is dominated by regulatory dossier accessibility (DMF), impurity controls, and the ability to transfer analytical and manufacturing methods quickly.
Finished-dose supply depends on ANDA sponsor manufacturing-site listings and the selected packaging and coating system.

FAQs

How can procurement teams identify azilsartan medoxomil API suppliers using DMFs and CMC references?
What are the most common quality spec risk points for azilsartan medoxomil API (impurities, residual solvents, polymorph)?
Which contract manufacturing capabilities are essential for transferring azilsartan medoxomil tablet production?
What excipient suppliers are typically qualified for film-coated tablet systems using HPMC-based coatings?
How do intermediate supply disruptions affect azilsartan medoxomil API batch release timelines?

References

U.S. Food and Drug Administration. DMF and drug product listing resources. (FDA website).

Suppliers and packagers for AZILSARTAN MEDOXOMIL