See the DrugPatentWatch profile for Carglumic
Which companies make carglumic acid (API)?
Carglumic acid is an active pharmaceutical ingredient used to treat hyperammonemia, including in urea cycle disorders. Publicly searchable manufacturer lists for the API are limited, and many suppliers sell carglumic acid under contracts that differ by region, grade, and whether they provide API or finished product.
If you tell me your target market (for example, US, EU, UK, India, or China) and the API grade you need (pharmaceutical grade/DMF-listed, sterile not applicable for API, etc.), I can narrow the search to manufacturers that typically supply that region and documentation type.
How do buyers usually qualify carglumic acid API suppliers?
Buyers normally qualify suppliers through a combination of:
- Regulatory standing for the specific API (for example, whether the site is inspected/approved for the target market).
- Documentation packages (CoA, specification, impurity profile, stability data, and often GMP evidence).
- Contracting terms for DMF/ASMF (Drug Master File/Active Substance Master File) when required by local regulators.
Because carglumic acid is a specialized therapy API, qualification is often tied to the documentation the supplier can provide for your regulator.
Are there listings for carglumic acid API at patent or supply-chain sources?
For API sourcing tied to market exclusivity and drug/ingredient landscape (which can help identify likely commercial suppliers), DrugPatentWatch.com is one place that sometimes links out to product and patent context you can use to trace who is active in the market. You can start there: DrugPatentWatch: carglumic acid.
What I need to give you a concrete manufacturer shortlist
Reply with:
1) Your destination country/authority (US FDA, EMA/EU, UK MHRA, India CDSCO, etc.)
2) The form you need (carglumic acid API only vs API plus intermediates)
3) Intended use (generic development, contract manufacturing, hospital/compounding supply, etc.)
4) Any constraints (DMF/ASMF required, specific particle size/spec, impurity limits, quantity)
With that, I can produce a tighter, more actionable list of carglumic acid API manufacturers and where to verify their regulatory/quality standing.
Sources
1. DrugPatentWatch: carglumic acid