Suppliers and packagers for generic pharmaceutical drug: amlodipine benzoate

amlodipine benzoate

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	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340	NDA	Azurity Pharmaceuticals, Inc.	52652-5001-1	1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE	2019-08-15

Suppliers and packagers for generic pharmaceutical drug: amlodipine benzoate

Last updated: April 23, 2026

Who supplies amlodipine benzoate for pharma use?

Amlodipine benzoate is the benzoate salt of amlodipine (a calcium channel blocker). Commercial supply is dominated by the same ingredient-and-salt supply chain used for amlodipine besylate and amlodipine maleate: API and/or salt-form intermediate sourcing, followed by API-to-salt conversion or finished-dose formulation supply.

What supplier categories cover “amlodipine benzoate”?

Aminated into three practical procurement routes:

1) API/salt manufacturers (commercial bulk)

• Sell amlodipine benzoate as a bulk chemical (salt form) suitable for formulation.

2) CMOs/CDMOs for salt formation or compounding

• Convert an amlodipine free base or alternative salt into amlodipine benzoate and provide validated salt-form processes, powder specs, and documentation.

3) Finished-dose drug manufacturers

• Provide product where the API salt form is locked through the formulation process; procurement is usually product-level rather than raw-material-level.

Who are the typical global suppliers?

Below are supplier archetypes that repeatedly show up in pharmaceutical supply chains for amlodipine salts (including benzoate forms) via catalog listings, regulatory-facing manufacturing footprints, and bulk-chemical distribution.

1) API and salt ingredient suppliers (bulk)

These suppliers typically offer amlodipine as API and also supply salt forms as catalog items or via contract manufacturing:

• Cipla (India) – operates API manufacturing and is a common amlodipine-source in global supply chains.
• Sun Pharmaceutical Industries (India) – supplies amlodipine API and participates in salt-form supply for finished formulations.
• Aurobindo Pharma (India) – known for API manufacturing scale for many cardiovascular agents including amlodipine.
• Natco Pharma (India) – supplies APIs for multiple generics; ingredient sourcing is commonly seen across global partners.
• Cadila / Zydus (India) – produces APIs for cardiovascular portfolios including amlodipine.
• Hetero Drugs (India) – API manufacturer and formulation supply chain presence for cardiovascular products.
• Teva (Israel) and Teva API (global) – supplies generic APIs widely through internal and partner networks.
• Sandoz (Novartis, Switzerland) – supplies generic cardiovascular products and API inputs.
• Mylan/Viatris (global) – participates in generic drug supply for cardiovascular molecules; ingredient sourcing occurs through internal and partner networks.
• Torrent Pharmaceuticals (India) – supplies APIs for cardiovascular indications.

2) Contract manufacturers for salt formation (benzoate conversion)

Salt formation and crystallization are often handled by CDMOs with strong particle engineering and process validation. Typical candidates include:

• Lonza (Switzerland) – process development and manufacturing capabilities in APIs and intermediates used for salts and solids.
• WuXi AppTec (China) – development-to-manufacturing for solid forms and API processes.
• Catalent (US/global) – solid form and manufacturing services used in drug product supply chains.
• Recipharm (Sweden/Europe/global) – formulation and manufacturing services, including solids handling and scale-up.
• Piramal Pharma Solutions (India/Global) – API and intermediates manufacturing and development services.
• Ajinomoto Bio-Pharma Services / AJ Biologics and associated solid-form CDMO networks (Asia) – not specific to benzoate, but routinely used for salt/solid-form work in pharma supply chains.

3) Distributors who market amlodipine benzoate as a catalog chemical

These are brokers/chemical distributors that sell salts and intermediates in smaller bulk quantities, typically with batch documentation. Common distribution networks include:

• TCI Chemicals (Japan) (catalog distribution model)
• Alfa Aesar / Thermo Fisher Scientific (US/global) (catalog chemicals distribution model)
• MedChemExpress, Selleck Chemicals, BOC Sciences (US/Asia) (research-grade and small-batch chemical distribution model)

These distributors may not supply GMP-grade material unless explicitly stated for a specific item and batch, so procurement typically requires direct verification of GMP/CoA/DMF linkage during quality review.

How to narrow suppliers to “amlodipine benzoate” specifically

Amlodipine has multiple common salts. Procurement should lock to the salt identity and documentation, not just the parent API.

Procurement identifiers that typically differentiate suppliers:

• Chemical form: “Amlodipine benzoate” vs “amlodipine besylate” vs “amlodipine maleate”
• GMP status: API manufacturing site certification and batch CoA
• Regulatory dossier linkage: DMF/EDMF availability for the salt form (where applicable)
• Solids behavior: polymorph/crystal habit and particle size distribution (PSD) where relevant for compressibility and stability

Supplier short list by procurement route

Use the route below to match the type of supplier needed.

Procurement route	What the supplier provides	Best-fit supplier profile
Bulk raw material purchase	GMP-grade amlodipine benzoate (salt)	API manufacturers and salt-form specialists with controlled crystallization
CDMO salt formation/manufacturing	validated benzoate conversion plus specs	CDMOs with solid-state/process development for salt form
Finished dose procurement	tablets/capsules where salt form is fixed in formulation	Finished-dose generics or originator distribution channels

Actionable sourcing checklist (what to request from any supplier)

The following items are typically decisive for whether a supplier can actually ship amlodipine benzoate suitable for pharma production:

1) Material identity and salt confirmation

• IR and/or XRPD identity method referencing “amlodipine benzoate”
• Benzoate content or acid/anion assay

2) Specifications

• Water content (KF or LOI)
• PSD (if relevant)
• Impurities profile (including any residual solvents)

3) Supply documentation

• CoA for the specific batch
• GMP manufacturer statement and site details
• Change control policy (salt form stability and process changes)

4) Stability and packaging

• Recommended storage temperature and humidity range
• Packaging configuration used for stability program

Key Takeaways

• “Amlodipine benzoate” sourcing sits in the same supplier ecosystem as amlodipine API and amlodipine salts, with the critical step being salt-form confirmation and GMP dossier linkage for the exact anion form.
• Supplier selection should be structured by procurement route: bulk API/salt purchase, CDMO salt formation, or finished-dose supply.
• The fastest path to operational fit is usually: (1) an API/salt manufacturer that already sells the benzoate salt, or (2) a CDMO with validated benzoate salt formation and controlled solids specs.

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FAQs

1) Is amlodipine benzoate supplied by the same companies that supply amlodipine besylate?

Yes. Many API manufacturers and formulation supply chains handle multiple amlodipine salts; the key differentiator is whether they produce and release the benzoate salt with appropriate documentation and specs.

2) How do I verify that a supplier is actually providing amlodipine benzoate, not another salt?

Request batch-level analytical identity methods tied to “amlodipine benzoate” (for example XRPD/IR) plus an assay that quantifies the benzoate anion or confirms salt composition.

3) Can a CDMO convert amlodipine to the benzoate salt form?

Yes. Salt formation and crystallization are standard CDMO capabilities for solid form engineering, including benzoate conversion, provided the process is validated and the solid form is controlled.

4) Do chemical distributors qualify as GMP sources for pharma manufacturing?

Often only if they explicitly sell GMP-grade material for the specific item and batch. Catalog chemical distributors frequently operate in research-grade channels unless stated otherwise.

5) What specs matter most for amlodipine benzoate in tablet production?

Salt identity, moisture content, impurity profile, particle size distribution, and stability data under defined temperature/humidity conditions.

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References

[1] PubChem. “Amlodipine Benzoate.” National Center for Biotechnology Information (NCBI).
[2] European Medicines Agency (EMA). “Procedural Advice for Users of the Centralised Procedure.” (General regulatory context for APIs and salt forms).
[3] FDA. “Drug Master Files (DMF).” U.S. Food and Drug Administration.
[4] World Health Organization (WHO). Guidelines on validation and quality of pharmaceuticals manufactured in regulated manufacturing sites (general GMP/quality framework).