Flupirtine Maleate API Manufacturer & Supplier in India

What is Flupirtine Maleate API?

Flupirtine (CAS No. 75507-68-5) is an aminopyridine-derivative compound that functions as a centrally acting, non-opioid, non-NSAID analgesic — a pharmacological profile that is genuinely uncommon among pain-management APIs. Its primary mechanism is as a selective neuronal potassium channel opener, specifically activating KCNQ/Kv7 channels, which reduces neuronal excitability; it also exhibits NMDA-receptor antagonist properties that contribute to its analgesic effect through a separate pathway. Flupirtine has been used clinically since the 1980s, first available in Europe, and is known internationally under several brand names including Katadolon.

Apex Pharma API supplies Flupirtine Maleate as the maleate salt of flupirtine, prepared to improve handling and processing. Because the compound does not carry the dependency profile associated with opioid analgesics, it has historically been of particular interest to formulators developing non-opioid pain-management products. We manufacture and supply the API itself, not the finished branded or generic product.

Flupirtine Maleate API manufacturing at Apex Pharma API

We have manufactured Flupirtine Maleate in-house since 2015 at our Saykha GIDC plant in Bharuch, on a single established route that keeps the impurity profile consistent between campaigns — an advantage that matters for a specialised molecule with a limited supplier base. Production runs in a 4 KL stainless-steel reactor, so we supply from evaluation samples through to repeat commercial volumes, and you buy directly from the plant that makes it with the QC team that released the batch on hand. Our complete product range and general sourcing process are covered on our API manufacturing page.

Applications and uses

Flupirtine Maleate API is used in the formulation of non-opioid, non-NSAID analgesic medicines for pain management. Its distinct mechanism — working through potassium-channel modulation and NMDA-receptor antagonism rather than the prostaglandin-inhibition pathway used by NSAIDs or the opioid-receptor pathway used by narcotic analgesics — makes it a pharmacologically distinct option for formulation companies building differentiated pain-management products. This is general pharmacological context for buyer understanding, not a claim about specific finished products manufactured by our customers.

Industries and customers we serve

Flupirtine Maleate API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers developing analgesic 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.

Flupirtine Maleate API export and supply considerations

The market and regulatory status of flupirtine is not uniform globally and has changed over time in some regions, so a buyer sourcing Flupirtine Maleate API — whether directly or for onward export — should confirm the specific requirements and approval status of their destination market as part of their own regulatory due diligence. We supply non-regulated export markets, with export documentation prepared in-house. Share your destination and we will confirm what is required before you order.

Why choose Apex Pharma API for Flupirtine Maleate API

• GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
• Manufactured in-house since 2015 on a single established route at our Saykha GIDC plant, so the impurity profile is consistent campaign to campaign.
• A batch-wise Certificate of Analysis as standard, with MSDS, specification sheet and method of analysis available, and DMF documentation on request.
• Manufacturer pricing, quoted directly — supply from trial quantities through to repeat commercial volumes, with evaluation samples available before a bulk order.