See the DrugPatentWatch profile for Ranolazine
Which companies make ranolazine API (active pharmaceutical ingredient)?
Ranolazine APIs are typically produced by generic and specialty API manufacturers that supply contract manufacturing and downstream generic drug makers. However, the specific “ranolazine API manufacturer” names can vary by supplier, site, and supply chain, and aren’t consistently published in a single authoritative list in the information provided here.
If you share either (1) the country/region you’re buying from (e.g., India/EU/US), (2) the intended use (commercial drug product vs. research), and (3) required standard (typically CEP/DMF, GMP grade, or US/EU registrations), I can narrow to the most relevant supplier profiles and how to verify them.
How to verify a ranolazine API supplier is legitimate (GMP/DMF/CEP)?
When sourcing ranolazine API, buyers usually check for documentation that supports regulatory compliance:
- API regulatory filings such as a US DMF or an EU CEP (if applicable to the supplier).
- GMP manufacturing status for the specific manufacturing site.
- Batch/CoA availability and testing methods for identity, assay, impurities, and residual solvents.
- Quality agreements and traceability.
If you tell me your target market (US vs EU vs ROW), I can outline the exact documents buyers typically request for that region.
What specs and forms matter for ranolazine API sourcing?
Common procurement requirements include:
- Ranolazine polymorph and solid-state form (if specified by the drug master file/product filing).
- Impurity profile alignment with the finished-dose specification (assay limits and impurities).
- Solvent/residual limits and stability data expectations.
- Particle size/granulation constraints (more common when the supplier also handles intermediate or drug-product manufacturing).
Are there multiple API versions (salt form vs free base) to confirm?
Ranolazine is supplied as an API with defined chemical form; the critical point for sourcing is matching the form and specification expected by your drug product manufacturer or regulatory filing. If your target drug product uses a particular spec set, your API vendor should confirm compatibility.
How can you find the right ranolazine API manufacturers for your exact need?
A practical short path is:
1. Identify the finished-dose market/regulatory pathway you care about (US ANDA, EU generic/abridged route, etc.).
2. Ask your downstream manufacturer (or look up the drug product) what API reference/spec they use.
3. Request DMF/CEP references tied to the actual manufacturing site.
4. Screen suppliers for GMP status and the ability to meet your batch size/timeline.
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Quick questions so I can give you a targeted list of ranolazine API manufacturers
1) What country/region are you sourcing for (US, EU, India, other)?
2) Do you need CEP/DMF documentation, or is research-grade acceptable?
3) What quantity and timeline (kg/tons, and how soon)?