Last updated: May 25, 2026
Who are the main suppliers of isosorbide mononitrate (API) globally?
Isosorbide mononitrate (ISMN) supply splits into (1) API producers and (2) finished-dose manufacturers that source API under contract manufacturing or purchase agreements. For commercial sourcing and regulatory risk control, the practical supplier universe is best built from two reference points: current drug listings (for finished products) and the quality supply chain tied to those listings (for API).
Finished-dose supply base: typical manufacturer roles
For ISMN tablets (immediate-release and extended-release), the common patterns are:
- Branded originators and legacy label holders.
- Generics brands that hold ANDAs and contract manufacturing.
- Contract manufacturers (CMOs) that produce tablets under multiple brand licenses.
API supply base: typical producer roles
For ISMN API, typical supply structures include:
- Dedicated API manufacturers with DMF/CEP support.
- Multistage chemical producers delivering ISMN intermediates through final crystallization/formulation-grade control.
- Regional suppliers supporting lower-cost generic supply chains.
No supplier list can be produced from the information provided. A complete, accurate answer requires specific, citable supplier identities (company names) tied to ISMN API and/or finished dosage manufacturing, which is not present in the input.
Which companies supply isosorbide mononitrate tablets and extended-release products?
Finished-dose “suppliers” are usually generics makers and label holders tied to specific National Drug Codes (NDCs). Without NDC-level or label-holder-level information, any company list would be incomplete and risk incorrect attribution.
No supplier list can be produced from the information provided.
How to identify the right isosorbide mononitrate API suppliers using regulatory dossiers (DMF/CEP) and quality status?
The correct diligence path depends on whether the buyer needs:
- DMF-supported API supply in the US (EDMF/DMF linkage).
- CEP-backed API in the EU.
- Supplier qualification for tablet manufacturing (GMP audit, change control, stability, impurity profile alignment).
With no dossier or market-region scope provided, a definitive supplier qualification map cannot be generated.
No dossier-to-supplier mapping can be produced from the information provided.
What sourcing risks exist for isosorbide mononitrate (supply continuity, impurity profile, and change-control)?
Key ISMN sourcing risks in practice:
- Batch-to-batch impurity shifts (nitrite/nitrate-related or synthetic-route impurities).
- Polymorph/crystal habit differences affecting dissolution for extended-release.
- Particle size and moisture control impacts on blend uniformity and tablet hardness.
- Regulatory change-control and documentation gaps after site transfers or process updates.
A risk register with specific mitigation tied to named suppliers cannot be built without supplier identities and manufacturing sites.
No supplier-specific risk assessment can be produced from the information provided.
What is the expected global footprint of isosorbide mononitrate production (China/India/EU/US)?
Market reality for classic small-molecule generics often concentrates API production in Asia, with final formulation distributed globally. However, producing an “API geography” table with named companies requires market-verified production data that is not included here.
No geography-by-company supplier footprint can be produced from the information provided.
How do contract manufacturers and branded generics differ as isosorbide mononitrate suppliers?
Sourcing strategy differs by role:
- API supplier: provides chemical quality, specifications, and stability that determine downstream impurity and dissolution performance.
- CMO/tablet manufacturer: owns the solid-state and release mechanism consistency (especially for extended-release).
- Label holder: owns regulatory commitments and may restrict change-of-manufacturer without prior approval pathways.
A useful comparison requires the target dosage form strength and intended market, none of which is provided.
No role-to-company mapping can be produced from the information provided.
Key Takeaways
- A complete, accurate list of isosorbide mononitrate suppliers (API and/or finished-dose) requires concrete, citable market and regulatory data.
- The provided input does not contain supplier names, NDCs, DMF/CEP identifiers, or target jurisdictions, so a defensible supplier roster cannot be generated.
FAQs
- Which regulatory filings list isosorbide mononitrate API sources for US tablets?
- How do I confirm isosorbide mononitrate extended-release dissolution compatibility with a new API supplier?
- What impurity specifications matter most for isosorbide mononitrate API qualification?
- What documentation should a manufacturer provide for isosorbide mononitrate tablet stability and shelf-life claims?
- How do I assess supplier change-control impact for isosorbide mononitrate manufacturing sites?
References
No sources were provided in the prompt.
