Last updated: May 28, 2026
VASOTEC (enalapril maleate) suppliers: API, finished dose, and key manufacturers
Executive summary: VASOTEC is an enalapril maleate brand. The market supply chain is built around (1) enalapril maleate API manufacturers and (2) finished-dose tablets sourced by the brand/authorized MAH and its distributors. Core supplier mapping depends on the specific market (US vs EU vs other jurisdictions) and the dosage form (tablets vs any country-specific presentations). Without jurisdiction and listing context, a complete, definitive supplier roster cannot be produced.
Who supplies the enalapril maleate API used for VASOTEC?
Answer: Enalapril maleate for branded enalapril products is supplied by multiple generic/API manufacturers globally, with contracts tied to each market’s regulatory and quality requirements. A complete supplier list for “VASOTEC” specifically cannot be stated from brand name alone because enalapril is sold widely as generic and because supplier attribution varies by country and inspection batch.
What counts as an “API supplier” for VASOTEC?
API suppliers are typically identified via:
- DMF/RLD reference information (US FDA DMF status for enalapril maleate)
- European CEP/EDQM provenance (for EU markets)
- Filings showing API manufacturer sites used in the finished product
- Batch-level documentation tied to the finished dose MAH
What is the usual drug substance specification?
Enalapril maleate API is generally supplied as:
- chemically synthesized small-molecule API
- controlled by impurity profiles and polymorph/solid-state specifications (where applicable)
Which companies manufacture the VASOTEC tablets in different countries?
Answer: Finished-dose tablet manufacturing is performed by specific contract manufacturers and/or in-house sites under the marketing authorization holder’s quality system. The set of tablet manufacturers can differ by:
- country (US, Canada, EU, LATAM, MENA, APAC)
- dosage strength (commonly 2.5 mg, 5 mg, 10 mg, 20 mg in many markets)
- packaging format (bottles vs blisters)
- historical manufacturing site changes after inspections and site transfers
What is the FDA and Orange Book status of VASOTEC that indicates supplier responsibility?
Answer: FDA “supplier” inference for VASOTEC is indirect. Orange Book listings and labeling identify:
- NDA holder (and sometimes key labeling/manufacturer fields)
- dosage form strength and submission history
They do not reliably enumerate the API manufacturer(s) used by every production lot.
What do Orange Book fields typically tell you?
- Applicant/holder name
- NDA and approval history
- Therapeutic equivalence ratings for competitors
This can help map who controls US commercial supply, but it does not produce a clean “all suppliers of VASOTEC” list without the specific NDA listing context.
Does VASOTEC source API from multiple plants or only one supplier?
Answer: Multi-sourcing is common for enalapril products because:
- API is widely available as a commodity-like intermediate (with significant supplier overlap)
- finished-dose manufacturers qualify multiple drug substance sources to manage continuity of supply
A single-supplier claim for “VASOTEC” cannot be verified without the NDA/CMC supplier-site mapping for the specific market.
How do generic enalapril tablets compete with VASOTEC on supply and sourcing?
Answer: Generic enalapril tablet manufacturers typically:
- buy enalapril maleate API from one or more qualified suppliers
- manufacture tablets under cGMP using validated formulation and process controls
- compete on price and continuity, often adding more supplier options during contract manufacturing transitions
This affects VASOTEC supply indirectly through market pressure but does not identify VASOTEC’s own suppliers.
What supply-chain differences matter for IP and litigation?
If you are mapping IP boundaries or manufacturing redesign risks, the relevant point is not the “generic supplier list,” but whether:
- VASOTEC formulation/process patents exist in the relevant jurisdiction
- any manufacturing method changes trigger new filings or comparability requirements
What are typical VASOTEC business supply roles (MAH vs CMO vs distributor)?
Answer: In most regulated markets the supply roles split into:
- Marketing Authorization Holder / NDA holder: controls product authorization and quality system
- API manufacturer: supplies enalapril maleate API used by the finished dose
- Finished-dose manufacturer (CMO and/or in-house): produces tablets, packages, releases lots
- Distributor/pharmacy supply chain: logistics and wholesaling, not manufacturing
A complete supplier map requires market-specific labeling and regulatory submission data.
What is the supplier risk for enalapril maleate (continuity of supply)?
Answer: For enalapril maleate, key supply risk drivers are:
- API site qualification and post-approval inspection outcomes
- impurity specification compliance across batches
- geopolitical and logistics disruptions for raw materials and intermediates
- changes in approved CMC documentation when new API sources are added
Key Takeaways
- VASOTEC is an enalapril maleate brand; “suppliers” split into API and finished-dose tablet manufacturing.
- A definitive list of “VASOTEC suppliers” cannot be produced from brand name alone because supplier attribution is jurisdiction- and site-specific and may change over time.
- Orange Book and regulatory listings help identify the market authorization holder, but they do not reliably enumerate all API plants used by VASOTEC production lots.
- Supply continuity analysis should focus on API source qualification, finished-dose manufacturing sites, and regulatory CMC history tied to the specific NDA/market.
FAQs
- Which company currently holds the US NDA for VASOTEC (enalapril maleate)?
- Do Orange Book listings for enalapril tablets identify the API manufacturer plants?
- How can I determine the finished-dose manufacturer of VASOTEC tablets from labeling?
- What cGMP inspection findings most often disrupt enalapril maleate supply?
- Do generic enalapril tablets use the same API suppliers as VASOTEC in the US?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Master Files (DMF) database and guidance. FDA. https://www.fda.gov/
