Anti-epileptic API
Lacosamide API
Manufactured in-house at our Saykha GIDC plant in IP, BP, USP and EP grades — supplied with batch CoA and a full analytical data package for regulated filings.
Overview
Lacosamide is an anti-epileptic agent used in formulations for partial-onset seizures, supplied as monotherapy and adjunctive therapy across tablet, oral solution and injectable presentations. It is a regulated-filing molecule where authorities scrutinise the impurity profile closely, so formulators need a source that controls related substances tightly and can back every batch with complete analytical data.
Apex Pharma API has manufactured Lacosamide since 2015 on a single established route, which keeps the impurity profile consistent between campaigns and supports a full analytical data package for regulated submissions. You buy directly from the plant that makes it, with the QC team that released the batch available to answer your questions.
Specifications
| Product name | Lacosamide (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 175481-36-4 |
| Molecular formula | C13H18N2O3 |
| Molecular weight | 250.29 |
| Grades available | IP · BP · USP · EP |
| Appearance | White to off-white crystalline powder |
| Assay | Per applicable pharmacopoeial monograph (grade-specific) |
| Packaging | 1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request |
| Storage | Store in a tightly closed container, protected from light and moisture, at controlled room temperature |
| Supply capacity | Trial quantities to repeat commercial volumes — confirmed at quotation |
Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.
Applications
Oral solid dosage forms for partial-onset seizures as monotherapy or adjunctive therapy.
Liquid presentations where tight control of related substances is critical.
High-purity grade material for sterile injectable presentations requiring low impurity limits.
Reference-grade material with a full analytical data package for ANDA and dossier submissions.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
Lacosamide API — buyer questions
What is the minimum order quantity for Lacosamide API?
We supply from trial quantities upward. The commercial MOQ is confirmed against your grade and packaging requirement at quotation and is not a single fixed figure.
Can I get a sample with a CoA and impurity data?
Yes. Samples are issued with the batch CoA and impurity profile so your QC team can verify against your own specification before raising a purchase order.
What lead time applies?
Stocked grades despatch within days of order confirmation. Campaign quantities are scheduled and a firm date is confirmed before you commit.
What analytical documentation is available for filings?
A full analytical data package — DMF, open-part documentation, impurity characterisation and method details — is available on request. Tell us the market and we will confirm the scope.
Related products
Read: Lacosamide uses and applications →Get a Lacosamide API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.