AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	217279	ANDA	Alembic Pharmaceuticals Limited	46708-755-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-755-30)	2025-05-23
Alembic	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	217279	ANDA	Alembic Pharmaceuticals Limited	46708-755-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-755-90)	2025-05-23
Alembic	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	217279	ANDA	Alembic Pharmaceuticals Limited	46708-756-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-756-30)	2025-05-23
Alembic	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	217279	ANDA	Alembic Pharmaceuticals Limited	46708-756-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-756-90)	2025-05-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 24, 2026

Amlodipine Besylate and Atorvastatin Calcium Suppliers (API, Excipients, Finished Dosage)

Suppliers for amlodipine besylate and atorvastatin calcium are concentrated in three tiers: (1) API makers, (2) contract manufacturers for tablets and capsules, and (3) excipient and packaging suppliers used in compressed solid oral dosage forms. This supply base is global and largely interchangeable at the finished-dosage level, while IP, DMF coverage, and GMP inspection outcomes typically restrict API substitution and drive vendor qualification cycles.

Amlodipine besylate: which supply tiers exist and who typically sells into the market?

Amlodipine besylate is commonly sourced through:

API vendors (amlodipine besylate as the active pharmaceutical ingredient)
Finished-dose CDMOs (tablet manufacture, compression, film coating, packaging)
Excipients and coating system suppliers (binder, disintegrant, lubricant, film coat, colorants)

Atorvastatin calcium: which supply tiers exist and who typically sells into the market?

Atorvastatin calcium is commonly sourced through:

API vendors (atorvastatin calcium API, often under DMF)
Finished-dose CDMOs for tablets (wet granulation or direct compression, film coating, packaging)
Excipients and coating system suppliers (same archetype as above, with formulation-specific specs)

What are the main suppliers of amlodipine besylate API (global manufacturer list)?

API supply is the critical path for amlodipine besylate because ANDA entrants typically depend on DMF access and consistent impurity profiles tied to the synthetic route.

Common API supplier categories

Multinational API manufacturers (broad portfolio, DMF coverage for multiple statins and antihypertensives)
Large Indian and Chinese API producers (high-volume, competitive pricing, high switching risk around inspections or DMF status)
Specialty intermediates players (supply of key intermediates that are upstream of API)

Typical sourcing approach

Qualify one primary API vendor and one contingency vendor
Require CoA, impurity spec alignment, and full CMC dossier compatibility (DMF cross-reference and letter-of-access)

What are the main suppliers of atorvastatin calcium API (global manufacturer list)?

Atorvastatin calcium API supply is heavily driven by:

DMF availability and demonstrated manufacturing reproducibility
Regulatory history (inspection outcomes, compliance statements)
Ability to meet tight genotoxic/impurity controls that matter for solid-dose statins

Typical sourcing approach

Dual sourcing for API
Strong emphasis on impurity profile and polymorph/control strategy used in the API manufacturing process

Which CDMOs manufacture amlodipine besylate tablets and film-coated products?

At the finished dosage layer, companies typically compete on:

Tablet press capacity and scale-up experience for high-volume antihypertensive tablets
Coating and packaging lines (blister and bottle) with validation packages aligned to US and EU requirements
Ability to support tech transfer and ongoing process validation

Where substitution is easiest

Excipient and coating systems can be adjusted within specification.
Switching CDMO is often less constrained than switching API vendor, provided bioequivalence path and impurity controls are preserved.

Which CDMOs manufacture atorvastatin calcium tablets and film-coated products?

For atorvastatin calcium tablets, CDMO selection is driven by:

Coating uniformity and film defect control
Granulation method capability for consistent dissolution and bioequivalence
Ability to run high-throughput tablet manufacturing with stable impurity controls and cleaning validation

What excipient suppliers support amlodipine besylate tablet formulation?

Amlodipine besylate tablets typically rely on standard solid oral excipient families:

Binders (for granulation or compaction)
Disintegrants (for fast breakup)
Lubricants (for flow and ejection)
Film coat polymers and plasticizers (for controlled dissolution and appearance)
Colorants and opacifiers when required

Supplier selection tends to be constrained by:

Particle size distribution and polymorph compatibility
Regulatory acceptance history in US/EU
Availability for DMF/EDQM (where applicable)

What excipient suppliers support atorvastatin calcium tablet formulation?

Atorvastatin calcium tablet formulations typically use:

Binders and disintegrants calibrated for dissolution targets
Lubricant and glidant systems tuned to reduce variability in tablet hardness
Film coating systems that maintain stability and consistent release

Which packaging suppliers are commonly used for amlodipine and atorvastatin solid oral drugs?

Packaging suppliers usually cover:

HDPE bottles with induction seals
Blister packaging (PVC/PVDC-alternative film systems)
Desiccants and moisture protectants (when needed by stability studies)
Child-resistant closures where required by market strategy

How do DMFs and regulatory filings affect which suppliers can be used for amlodipine and atorvastatin?

Supplier eligibility for US-facing products often hinges on:

DMF access (letter of access and cross-reference capability)
Alignment of impurity specifications and residual solvents
Demonstrated process controls for the chosen synthetic route
History of FDA inspection outcomes for the API facility

This can create “effective exclusivity” at the supplier level even after patent expiry because not all API vendors can be substituted quickly.

When does supplier qualification become a launch risk for generics of amlodipine or atorvastatin?

Launch risk increases when:

A key API vendor’s DMF access is unavailable or delayed
There is an inspection outcome affecting the manufacturing site’s continued registration status
Impurity profile drift occurs after a synthetic step change
Switching packaging components creates stability failures (moisture ingress, seal integrity)

In practice, the critical path is:

API qualification and stability bridging plan
Tech transfer and equipment qualification at the CDMO
BA/BE execution and regulatory readiness for CMC updates

Which companies are active in both antihypertensive (amlodipine) and statin (atorvastatin) supply chains?

The strongest overlap in supply chains tends to occur at:

CDMOs that run high-volume tablets across therapeutic classes
Excipient and coating system vendors with broad portfolio acceptance
Large API houses that supply multiple statins and cardiovascular drugs

How does amlodipine besylate vs. atorvastatin calcium sourcing differ in practice?

Key practical differences:

Atorvastatin calcium API tends to face more scrutiny around impurity control and process reproducibility because of statin-specific impurity risk frameworks.
Amlodipine besylate often supports broader API interchangeability at the finished-dose level, assuming impurity profiles are aligned and the selected vendor has DMF access.

What “supplier switching” barriers block interchangeable substitution (API and intermediate level)?

Common blockers:

DMF access and letter of access timing
Differences in synthetic route that change impurity profiles
Facility registration status changes
Quality agreements requiring specific analytical panels (impurities, residual solvents, elemental impurities)
Stability sensitivity to crystal form and moisture/light conditions (product-specific)

Which sourcing geographies dominate for amlodipine and atorvastatin?

Market supply is typically dominated by:

India and China at the API and intermediate level (large capacity, variable inspection history)
Global multinational CDMOs and regional tablet packers at the finished-dose level

Key Takeaways

Amlodipine besylate and atorvastatin calcium supply is split between API qualification, CDMO manufacturing, and excipient/packaging sourcing.
For US launches, supplier selection is constrained by DMF access, impurity spec alignment, and site inspection outcomes.
Finished-dose CDMO switching is usually easier than API switching, but stability and CMC alignment still drive timeline risk.
Supplier qualification becomes a launch risk when DMF access, impurity drift, or stability failures occur during tech transfer.

FAQs

1) What is the fastest path to add a second API supplier for amlodipine besylate tablets?
A second supplier is typically added through DMF access (letter of access) plus a rapid impurity profile and stability bridging program tied to the intended dosage strength.

2) What controls are most important when qualifying atorvastatin calcium API from a new vendor?
Impurity profile match, residual solvent control, and reproducibility of the synthetic process are the most common gating items.

3) Can a CDMO switch packaging suppliers mid-development without delaying approval?
It depends on stability outcomes and labeling/closure validation packages, but packaging changes often trigger stability and design-of-equipment documentation updates.

4) Do excipient suppliers create more risk for statin tablets than antihypertensive tablets?
Formulation-specific dissolution and coating performance targets typically make excipient changes more sensitive for atorvastatin, but risk is product-specific.

5) Which documentation typically blocks supplier changes in ANDA CMC updates?
DMF cross-reference/LoA, quality agreement scope, analytical comparability data, and updated control strategy documents are the usual blockers.

References

FDA. ANDA Guidance Documents and CMC-related guidance resources. U.S. Food and Drug Administration.
FDA. Drug Master File (DMF) submission and regulatory framework. U.S. Food and Drug Administration.
European Medicines Agency. Scientific guidelines and GMP-related regulatory expectations for quality and manufacturing. EMA.

Suppliers and packagers for generic pharmaceutical drug: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM