Itopride HCl API Manufacturer & Supplier

What is Itopride Hydrochloride API?

Itopride Hydrochloride (CAS No. 122892-31-3) is a benzamide-derivative gastroprokinetic agent with a dual mechanism of action rather than a single pathway. It acts as a dopamine D2 receptor antagonist — removing the inhibitory brake that dopamine places on gastrointestinal motility — and it inhibits acetylcholinesterase, increasing acetylcholine availability at muscarinic receptors on gut smooth muscle and directly enhancing peristaltic contraction. The combined effect of these two independent mechanisms is a stronger prokinetic action than a single-mechanism agent typically achieves.

For a formulator, the practical point is that itopride is a repeat-demand generic molecule where a reproducible impurity profile and reliable delivery matter as much as price when placing recurring orders. Apex Pharma API manufactures and supplies the API itself, not the finished product.

Itopride Hydrochloride API manufacturing at Apex Pharma API

We have manufactured Itopride Hydrochloride in-house since 2015 at our Saykha GIDC plant in Bharuch, on an established route that keeps the impurity profile steady from campaign to campaign. 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

Itopride Hydrochloride API is formulated into gastroprokinetic medicines used to treat functional dyspepsia and related conditions involving delayed gastric emptying — symptoms such as bloating, early satiety and upper abdominal discomfort. Its dual mechanism enhances gastrointestinal motility through two independent physiological pathways simultaneously, which distinguishes it pharmacologically from single-mechanism prokinetic agents. 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

Itopride Hydrochloride API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers developing gastrointestinal-therapy tablets, 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 Itopride Hydrochloride 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 at our Saykha GIDC plant in Bharuch, in a 4 KL stainless-steel reactor, so the impurity profile stays consistent campaign to campaign.
• Batch-wise Certificate of Analysis issued as standard, with MSDS, specification sheet and method of analysis available, and DMF documentation on request.
• Manufacturer pricing, quoted directly — you buy from the plant that makes it, with evaluation samples and a batch CoA available before a bulk order.