Lacosamide API Manufacturer & Supplier in India

What is Lacosamide API?

Lacosamide (CAS No. 175481-36-4) is a functionalized amino acid — chemically (R)-2-acetamido-N-benzyl-3-methoxypropanamide — developed specifically as an anticonvulsant. Its mechanism of action is what sets it apart from older antiepileptic drugs such as phenytoin and carbamazepine: rather than affecting the fast inactivation of voltage-gated sodium channels, lacosamide selectively enhances slow inactivation, increasing the proportion of channels held in that slow-inactivated state. It is approved as adjunctive therapy for partial-onset seizures, and its underlying sodium-channel mechanism also contributes to analgesic activity relevant to neuropathic pain formulations.

It is a single-enantiomer molecule and a regulated-filing product 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 manufactures and supplies the API itself, not the finished product.

Lacosamide API manufacturing at Apex Pharma API

We have manufactured Lacosamide in-house since 2015 at our Saykha GIDC plant in Bharuch, on an established route that keeps the impurity profile consistent between campaigns and supports a full analytical data package for regulated submissions. Production runs in a 4 KL stainless-steel reactor, so we supply from evaluation samples through to repeat commercial volumes. Our complete product range and general sourcing process are covered on our API manufacturing page.

Applications and uses

Lacosamide API is formulated into anticonvulsant medicines used as adjunctive therapy for partial-onset seizures — typically prescribed alongside another antiepileptic medication rather than as monotherapy in most approved indications. Its distinct sodium-channel mechanism has also supported its use in some neuropathic pain formulations, an area that continues to attract clinical and formulation interest given the compound’s differentiated profile compared with older anticonvulsants. This is general pharmacological context for buyer understanding, not a claim about the specific finished products manufactured by our customers.

Industries and customers we serve

Lacosamide API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers developing anticonvulsant and pain-management products, to distributors supplying API onward within their own network, and to R&D and generic-development teams needing API for formulation trials ahead of scale-up. Our full buyer-segment breakdown is on the API manufacturing companies in India page.

Why choose Apex Pharma API for Lacosamide API

• Tight impurity control with a full analytical data package — impurity characterisation, method details and a batch CoA backing every batch for your regulated-market submission.
• A single-enantiomer molecule where chiral purity matters, controlled on an established route manufactured in-house since 2015 at our Saykha GIDC plant in Bharuch.
• GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
• Manufacturer pricing, quoted directly — you buy from the plant that makes it, with evaluation samples, a batch CoA and impurity data available before a bulk order, and DMF documentation on request.