Suppliers and packagers for ASPIRIN AND DIPYRIDAMOLE

ASPIRIN AND DIPYRIDAMOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	206392	ANDA	AvKARE	42291-116-60	60 CAPSULE in 1 BOTTLE (42291-116-60)	2017-04-27
Amneal Pharms	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	206392	ANDA	Amneal Pharmaceuticals LLC	65162-596-06	60 CAPSULE in 1 BOTTLE (65162-596-06)	2016-03-28
Dr Reddys	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209048	ANDA	NorthStar Rx LLC	16714-964-01	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-964-01)	2019-04-03

Aspirin and Dipyridamole API and Finished-Dose Supply Chain: Who Supplies APIs, Tablets, and Distribution Inputs by Region

Last updated: June 16, 2026

Executive summary
Aspirin and dipyridamole fixed-dose products are typically sourced through a small set of API manufacturers for each active ingredient (aspirin and dipyridamole) plus regional finished-dose tablet packers for the combination. Supplier availability is highly dependent on market-specific registrations (e.g., EU vs. US) and whether buyers procure (1) APIs, (2) contract-manufactured tablets, or (3) repackaged finished goods. Key commercial leverage points for buyers are (a) whether the API is sourced via Drug Master File (DMF) holders for regulatory submissions and (b) whether the finished-dose tablets are produced under the same sites used for approved specs, stability, and packaging configurations.

Scope note
This supply landscape cannot be completed without specifying the country/market and the exact product configuration (strengths, dosage form, and brand/generic). Under the provided prompt, no market or product strength is specified, so a complete, accurate supplier roster cannot be produced.

What companies supply aspirin APIs and how do buyers qualify them?

Featured snippet answer: Aspirin API supply typically comes from multinational and regional chemical manufacturers that qualify through DMF or site master file submissions and must meet compendial and registration specifications for aspirin content, assay impurities, and stability.

Common aspirin API qualification inputs

• API grade and compendial status (typically USP/EP-aligned specs for aspirin)
• Impurity profile controls (salicylic acid, acetylsalicylic acid related impurities)
• Trace metals and residual solvents (process-dependent)
• Polymorph/particle size controls (process-dependent; less visible in finished dose but critical for blending)

Buyer diligence checkpoints

• Whether the API supplier supports a DMF/ASMF pathway for regulatory submissions
• Batch-to-batch variability history for assay and impurity formation
• Sterility is not relevant, but microbial limits and endotoxin are still controlled for oral solids depending on local regulations and spec

Who supplies dipyridamole API and what manufacturing constraints matter?

Featured snippet answer: Dipyridamole API is supplied by a smaller set of specialty heterocycle API producers that can provide stable impurity control and reliable tablet blending performance.

Dipyridamole API quality focus areas

• Assay and related substances (process-dependent)
• Physical attributes relevant to tablet compression: particle size distribution and flow
• Solvent residues and drying parameters
• Melting behavior and stability under accelerated conditions

Buyer diligence checkpoints

• Ability to provide validation batches for the intended finished-dose process
• Supply continuity for the API grade used in approved reference formulations
• Analytical package completeness (COA format, impurity list, residual solvents, stability results)

Which suppliers provide the aspirin and dipyridamole fixed-dose tablets?

Featured snippet answer: Fixed-dose combination tablets are typically made by contract manufacturing organizations (CMOs) or finished-dose manufacturers under approved master formulas, with release specs aligned to the reference listed drug or local equivalents.

Finished-dose supply models

1. API-to-finished-dose integration
   Supplier manufactures both APIs (or qualifies them) then compresses and packages tablets.
2. API sourcing plus contract tablet manufacturing
   Buyer sources APIs and uses a CMO for compression, coating, and packaging.
3. Licensed repacking/distribution
   Distributor sells a packaged finished-dose product produced under an existing marketing authorization.

Tablet manufacturing elements buyers should lock

• Blend uniformity and tablet weight control
• Dissolution specifications for aspirin and dipyridamole in combination
• Coating and packaging compatibility (including moisture sensitivity)
• Stability protocol and packaging configuration used for market release

How does supplier choice change for US vs EU approvals?

Featured snippet answer: The supplier set changes because the regulatory pathway and listing requirements differ. US supply typically depends on ANDA cross-reference and Orange Book listings, while EU supply depends on MA authorizations and national variation acceptance.

US-specific buyer considerations

• Whether the finished-dose tablet is referenced through ANDA products and how API DMFs are supported
• Whether the market requires specific suppliers for release testing or stability commitments

EU-specific buyer considerations

• ASMF alignment with EU GMP site acceptance
• Variations and line extensions that can constrain re-sourcing of APIs or packaging

What Orange Book or EU register status affects who can supply?

Featured snippet answer: Patent and product authorization status affects which suppliers can legally market a specific aspirin-dipyridamole strength and dosage form in a jurisdiction. If the product is under exclusivity or active regulatory exclusivity, fewer players are positioned to supply.

Practical supplier impact

• In-market authorization holders can block entry for direct generic copies
• Authorized generics or locally registered equivalents determine current competitive supply

What contract manufacturing and re-packaging suppliers are typically involved?

Featured snippet answer: The combination’s supply chain usually includes at least one CMO for tablet compression and a packaging/release partner for blistering and cartoning, each with site qualification under GMP.

Contract supply risks that matter to buyers

• Packaging line changeovers that create spec drift (print, blister seal, moisture ingress)
• API resourcing that shifts impurity profiles and forces bridging studies
• Stability commitments tied to specific packaging SKUs

What generic entry risks exist if you re-source APIs or change sites?

Featured snippet answer: Re-sourcing aspirin and/or dipyridamole APIs or switching tabletting sites can trigger comparability and regulatory reporting requirements, which slows supply transitions and increases change-control burden.

Risk drivers

• Differences in impurity spectrum caused by different synthetic routes
• Different particle size affecting compression properties and dissolution
• Packaging and line configuration differences affecting moisture and dissolution performance

Key supplier selection criteria for aspirin and dipyridamole buyers

• Regulatory alignment: DMF/ASMF coverage for each API and approved manufacturing sites for finished dose
• GMP track record: audit readiness for compression, coating/blistering, and release testing
• Analytical package: full impurities, residual solvents, polymorph or physical attribute data where relevant
• Supply continuity: multi-month availability with committed lead times
• Change-control capability: ability to run bridging/compatibility work quickly if a site or API lot changes

Key Takeaways

• Aspirin and dipyridamole combination supply is split between API sourcing (two active ingredients) and finished-dose production or repackaging.
• Supplier eligibility depends heavily on jurisdictional regulatory status and whether buyers require DMF/ASMF-linked sourcing for submissions.
• The main operational barriers to switching suppliers are impurity profile control, particle/flow properties affecting dissolution, and packaging/moisture stability during storage.

FAQs

1. Do aspirin and dipyridamole tablet strengths affect which manufacturers can supply?
2. Is it easier to source aspirin API or dipyridamole API for contract tablet manufacturing?
3. What documentation is usually required for importing fixed-dose aspirin-dipyridamole tablets into regulated markets?
4. How often do packaging configuration changes require regulatory reporting for oral solid combinations?
5. Can a finished-dose CMO use different API suppliers without a full comparability study?

References

1. US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-16).
2. EMA. European public assessment reports (EPARs) and procedures for marketing authorization. (Accessed 2026-06-16).