Metadoxine API Manufacturer & Supplier in India

What is Metadoxine API?

Metadoxine (CAS No. 74536-44-0), chemically known as pyridoxine-pyrrolidone carboxylate, is an ionic compound formed by combining pyridoxine (vitamin B6) with pyroglutamic acid (2-pyrrolidone-5-carboxylic acid). It is used in the formulation of hepatoprotective medicines, with a well-documented role in managing acute and chronic alcohol intoxication and in supporting liver function in alcoholic liver disease. Its proposed mechanisms include accelerating the metabolism of ethanol and acetaldehyde, reducing oxidative stress and lipid peroxidation in hepatocytes, and limiting the collagen accumulation and inflammatory signalling associated with early-stage liver damage.

A well-characterised mechanism and a defined therapeutic niche make Metadoxine a molecule with steady, specific demand — useful context for buyers building a dependable supplier relationship around it.

Metadoxine API manufacturing at Apex Pharma API

We have manufactured Metadoxine in-house since 2015 at our Saykha GIDC plant, keeping the impurity profile consistent between campaigns. Because Metadoxine is used in both oral and injectable finished products, formulators may have grade or purity requirements tied to their intended dosage form — tell us the dosage form and we will confirm the grade and documentation that suit it. Our complete product range and general sourcing process are covered on our API manufacturing page.

Applications and uses

Metadoxine API is formulated into hepatoprotective medicines primarily used in the management of acute and chronic alcohol intoxication and in supporting liver function during early-stage alcoholic liver disease. Its combined action — accelerating alcohol metabolism while reducing the oxidative stress and inflammatory signalling that drive liver cell damage — positions it as a targeted therapeutic rather than a general-purpose liver-support ingredient. This is general pharmacological context for buyer understanding, not a claim about the specific finished-dose products manufactured by any Apex Pharma API customer.

Industries and customers we serve

Metadoxine API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers developing hepatic-support and alcohol-treatment 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 Metadoxine API

• Grade matched to your dosage form — USP, EP and in-house specification material, with the documentation clarified against your oral or injectable requirement before you order.
• GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
• In-house manufacturing since 2015, so the impurity profile is consistent campaign to campaign.
• Manufacturer pricing, quoted directly — you are buying from the plant that makes it, with a batch CoA as standard and DMF documentation available on request.