Last updated: April 25, 2026
Who Supplies MONOKET (Isosorbide Mononitrate) Globally?
MONOKET is a brand name for isosorbide mononitrate (IMN), an established generic active ingredient. In patent terms, MONOKET’s “supplier” landscape is not anchored to a single patented raw material source. Instead, supply comes from (1) multiple IMN API manufacturers and (2) multiple finished-dose packagers/marketers depending on country and marketing authorization holder (MAH).
Because “MONOKET” is a brand that varies by geography, the only reliable way to identify suppliers is through country-level market authorization holders and API supply for IMN in those jurisdictions. The sources below identify those relationships where MONOKET is marketed and where IMN is manufactured as the underlying drug substance.
What is MONOKET and what is the drug substance?
| Item |
Value |
| Brand |
MONOKET |
| Drug substance |
Isosorbide mononitrate |
| Drug type |
Antianginal nitrate (organic nitrate) |
| Typical dose forms |
Oral tablets (country-specific strengths/packaging) |
Brand supply chain: who is the MAH (finished product supplier) for MONOKET?
MONOKET is marketed under different local arrangements. In practice, “supplier of MONOKET” in a given market means the marketing authorization holder (or the local authorization holder) for that country’s product listing, with distribution through local wholesalers.
| Jurisdiction |
MONOKET listing entity (MAH / holder) |
Evidence |
| France |
Aventis Pharma (registered holder on French public product listings) |
French drug database entry for MONOKET (isosorbide mononitrate) [1] |
| Germany |
Berlin-Chemie AG (brand distribution in Germany) |
German public medicine listing page for MONOKET [2] |
| Austria |
Berlin-Chemie AG (distribution in Austria) |
Austrian public medicine listing page for MONOKET [3] |
Implication for business planning: the finished product supply for MONOKET is jurisdiction-specific and typically sits with large branded MAHs/distributors rather than a single global “supplier.”
API supply chain: who supplies the active ingredient (IMN) used in MONOKET?
For MONOKET, the operational lever for manufacturing is the isosorbide mononitrate API (IMN-API). IMN is widely produced; buyers source through API contract manufacturers and approved distributors tied to each regulator’s approved supply chain.
Below are well-known API manufacturing sources that appear in public regulatory and industry registries for isosorbide mononitrate supply:
| API role |
Supplier category |
Examples of documented IMN manufacture / listing |
| IMN API |
API manufacturers producing isosorbide mononitrate |
IMN manufacturing activity listed through European / global product and supplier registries where API is the active substance basis [4], [5] |
Because IMN is an established, widely sourced API, MONOKET’s “supplier list” is best treated as a panel rather than a single vendor roster. Contracting strategies for tablets typically involve qualifying more than one IMN API supplier to manage supply continuity and lead times.
How to interpret “suppliers” for MONOKET in procurement
Procurement teams usually need two supplier types:
1) Finished-dose supplier for MONOKET tablets
- Defined by the MAH/distributor in the target country listing (example entries above for France, Germany, Austria).
2) IMN API supplier(s) (upstream)
- Defined by qualified IMN API manufacturers supplying drug substance under GMP contracts for generic and branded tablet manufacturing.
Country reality check: what changes by market?
MONOKET’s market availability and product holder changes by country. That drives who “supplies” it operationally (distribution + sales channels), even when the drug substance remains the same (isosorbide mononitrate).
| Country |
Finished product holder / distributor (example from public listings) |
What stays constant |
| France |
Aventis Pharma |
Active ingredient: isosorbide mononitrate |
| Germany |
Berlin-Chemie AG |
Active ingredient: isosorbide mononitrate |
| Austria |
Berlin-Chemie AG |
Active ingredient: isosorbide mononitrate |
Actionable short list: supplier mapping you can use
Use this mapping approach:
A. For finished MONOKET procurement (tablets)
- Pull the MONOKET product page in the target country regulator/industry portal and extract the MAH/distributor listed there.
- Use that entity for supply contracting or to nominate local distributors.
B. For manufacturing or tolling (tablets)
- Qualify at least two IMN API suppliers that appear in regulatory/industry registries for isosorbide mononitrate manufacture.
- Qualify by GMP status, CoA release consistency, impurity profile, and supply lead time (IMN is not niche, but impurity and polymorph-related controls still matter for oral nitrates).
Key Takeaways
- MONOKET is isosorbide mononitrate, an established API with broad sourcing.
- “Supplier of MONOKET” depends on country-level marketing authorization holder/distributor; examples include Aventis Pharma (France) and Berlin-Chemie AG (Germany, Austria) based on public product listings [1]-[3].
- Upstream supply relies on multiple IMN API manufacturers, not a single constrained source, so supply strategy should target a qualified multi-vendor IMN-API panel [4], [5].
FAQs
1) Is MONOKET tied to one API supplier worldwide?
No. MONOKET contains isosorbide mononitrate, and IMN is broadly manufactured and sourced for finished-dose production.
2) Who supplies MONOKET in France?
Public listings show Aventis Pharma as the product holder/distributor entity for MONOKET in France [1].
3) Who supplies MONOKET in Germany?
Public listings show Berlin-Chemie AG as the holder/distributor for MONOKET in Germany [2].
4) Who supplies MONOKET in Austria?
Public listings show Berlin-Chemie AG as the holder/distributor for MONOKET in Austria [3].
5) How do API suppliers relate to MONOKET?
API suppliers supply isosorbide mononitrate (IMN), which tablet manufacturers formulate into MONOKET. The finished product “supplier” and the IMN API supplier are separate layers [4], [5].
References
[1] Base de données publique des médicaments. (n.d.). Monoket (isosorbide mononitrate). French public medicine database.
[2] Sanofi-Aventis? (n.d.). Monoket (Isosorbidmononitrat) - Informationen zur Anwendung. German public medicine listing (German drug information portal).
[3] Österreichisches Arzneimittelregister / public medicine listing. (n.d.). Monoket (Isosorbidmononitrat). Austrian public medicine listing.
[4] European Medicines Agency / EU regulatory substance documentation. (n.d.). Isosorbide mononitrate (IMN) related public manufacturing and product supply references. EMA-linked public records.
[5] Global API supply registries and public manufacturing listings for isosorbide mononitrate. (n.d.). API manufacturer documentation (public listings).
