Metoclopramide API Manufacturers and Suppliers in India
Metoclopramide API
Metoclopramide API is a dopamine D2 receptor antagonist used in anti-emetic and prokinetic formulations for nausea, vomiting, gastroparesis and gastro-oesophageal reflux. Bio-Synth manufactures it at Balanagar, Hyderabad, in two forms: Metoclopramide Hydrochloride (IP, BP, Ph.Eur and USP grades), which is the form used in almost all oral and injectable products, and Metoclopramide Base (Ph.Eur and BP). Both are made on the same site and released against the relevant pharmacopoeial monograph. Bio-synth is registered with China CDE for MCP HCl with a capacity of 1.5MT/month.
☐ Metoclopramide Hydrochloride (IP / BP/ Ph.Eur / USP)
Product Description
Metoclopramide Hydrochloride
CAS number: 54143-57-6 (monohydrate)
Chemical Name: 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide monohydrochloride monohydrate
Molecular formula: C14H22ClN3O2 · HCl · H2O
Molecular weight: 354.3 g/mol
Category: Anti-emetic, prokinetic
Grades: IP, BP, Ph.Eur, USP
Form and colour: White or almost white crystalline powder or crystals
Solubility: Very soluble in water, freely soluble in ethanol (96%), sparingly soluble in methylene chloride
Storage: Protected from light
Packing: As per requirement
Synonyms: MCP HCl
☐ Metoclopramide Base (Ph.Eur / BP)
Metoclopramide Base Description
CAS number: 364-62-5
Chemical Name: 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide
Molecular formula: C14H22ClN3O2
Molecular weight: 299.8 g/mol
Category: Anti-emetic, prokinetic
Grades: Ph.Eur, BP
Form and colour: White or almost white fine powder
Solubility: Practically insoluble in water, sparingly or slightly soluble in ethanol (96%), slightly soluble in methylene chloride
Storage: Protected from light, tightly closed container
Packing: As per requirement
Synonyms: MCP Base
The two forms are not interchangeable. The hydrochloride monohydrate carries one molecule of water, so its molecular weight is 354.3 g/mol, not the 336.3 g/mol of the anhydrous salt. When you compare quotations, check which form, which hydrate and which pharmacopoeia the price refers to.
Metoclopramide API Specification
Every batch ships with a Certificate of Analysis against the grade ordered. The monograph tests for Metoclopramide Hydrochloride cover appearance, solubility, identification (infrared and chloride), appearance of solution, pH, related substances by HPLC, water content by Karl Fischer, sulfated ash and assay. The USP grade adds the tests and limits of the USP monograph; the IP grade follows the Indian Pharmacopoeia.
Release limits published for the hydrochloride:
- ☐ Assay (anhydrous substance): 99.0% to 101.0% w/w
- ☐ Unspecified impurities: Not more than 0.1% each
- ☐ Total impurities: Not more than 0.2%
- ☐ Water (Karl Fischer): 4.5% – 5.5% w/w
- ☐ Residual solvents: Methanol not more than 3000 ppm Isopropyl alcohol not more than 5000 ppm
For the Base, limits follow the Ph.Eur monograph; the full specification sheet is sent with any quotation. Because the hydrochloride is very soluble in water and the base is practically insoluble, the choice of form is a formulation decision, not a price decision – confirm it before asking for a quote.
Metoclopramide API Manufacturers in India
Bio-Synth is the trading name of Biochemical and Synthetic Products Private Limited, founded in 1943 and operating from Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Hyderabad 500037, under manufacturer’s licence 118/HD/AP/96/B/R. Metoclopramide is one of the company’s longest-running products.
What sets the manufacturing apart is that the intermediates for Metoclopramide are made in-house rather than bought in. For a buyer that matters in three ways. Impurity control starts two or three steps before the final benzamide, so process impurities are known by structure and tracked from the point where they form. Change control is internal – a supplier switching a raw material does not silently change your impurity profile. And lead time is not hostage to a third party’s delivery schedule.
The final steps are run as a single campaign: formation of the hydrochloride salt, crystallisation to the monohydrate, drying to the water specification, milling and packing. The base is isolated before salt formation for customers who need it. Both products are released under the same quality system and manufactured in line with ICH Q7 principles for API GMP. Chemistry capability beyond this product is described on the reaction capabilities page.
Metoclopramide Intermediates Manufacturers and Suppliers in India
All intermediates for the Metoclopramide route are produced at the Balanagar site. Intermediates are supplied to third parties on request, subject to quantity and specification. The wider range of pharmaceutical intermediates made at the site is listed separately.
Metoclopramide API Suppliers in India
Bio-Synth supplies Metoclopramide Hydrochloride and Metoclopramide Base to formulators in India and to export customers. Standard packing is as per customer requirement, protected from light.
A first order normally follows this sequence: you send the form, grade, quantity and destination market; Bio-Synth returns a quotation with the specification sheet and a typical CoA; a sample is sent for your own analysis if required; and on order the batch is released with its CoA and safety data sheet. Regulatory support documentation, open and closed part DMF for the product is available on request.
Metoclopramide API Price in India
Metoclopramide is a mature, multi-source API, so prices in India are set by grade, form and volume rather than by scarcity. Four things move the number. Grade: USP and Ph.Eur material that must meet tighter related-substance limits costs more to release than IP material. Form: the hydrochloride monohydrate and the base are priced separately. Volume: a standing annual contract is priced differently from a one-off 25 kg order. Documentation: customers who need regulatory support beyond the CoA should say so at the enquiry stage, because it is part of the price.
Public marketplace listings show how wide the spread can be. Those listings do not always state the grade or the pack. Bio-Synth quotes per enquiry and does not publish a list price. Send the form, grade and quantity for a current quotation.
Quality and Compliance
The Balanagar site holds ISO 9001:2015 certification from DNV Business Assurance (UKAS-accredited), certificate number 156792-2014-AQ-IND-UKAS, first issued on 20 August 2002, for the scope “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”.
For Metoclopramide Hydrochloride specifically, the site holds a Written Confirmation issued by CDSCO for export of the API to the European Union (WC-0274), the manufacturing site was inspected and that the API is manufactured in line with EU GMP-equivalent standards. A Written Confirmation is the document EU importers must hold for APIs sourced from outside the EU under Directive 2001/83/EC.
The site also holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana (L.Dis.No. 150458/TS/2024, valid to 05/06/2027). That certificate is issued under the export scheme for the products named in its inspection report, and Metoclopramide is not among them, so it is not cited here as a product-level approval for this API. APIs are manufactured in line with ICH Q7 principles; related substances are controlled with reference to ICH Q3A and residual solvents with reference to ICH Q3C. Quality systems across the site are described on the quality page.
How Metoclopramide Works and Where It Is Used
Metoclopramide blocks dopamine D2 receptors in the chemoreceptor trigger zone, which suppresses the nausea and vomiting signal, and in the upper gut, which speeds gastric emptying and tightens the lower oesophageal sphincter. At higher doses it also antagonises 5-HT3 receptors, adding to the anti-emetic effect. It does not increase gastric acid secretion.
The API goes into oral tablets and solutions, and into injections, for diabetic gastroparesis, chemotherapy- and post-operative nausea and vomiting, and symptomatic gastro-oesophageal reflux. The uses of Metoclopramide API in GI disorders and the Metoclopramide mechanism of action are covered in more depth on the blog.
Metoclopramide API FAQs
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Metoclopramide is a dopamine D2 receptor antagonist, classed as an anti-emetic and a prokinetic. At higher doses it also has 5-HT3 antagonist activity.
It is formulated into tablets, oral solutions and injections to treat nausea and vomiting, delayed gastric emptying (gastroparesis) and symptomatic gastro-oesophageal reflux disease.
No. Metoclopramide Base (CAS 364-62-5, MW 299.8) and Metoclopramide Hydrochloride monohydrate (CAS 54143-57-6, MW 354.3) are different products with different solubility, specifications and monographs. The hydrochloride is the form used in nearly all finished dosage forms.
Chemically it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide. In the trade it is abbreviated to MCP, MCP HCl or MCP Base.
Metoclopramide Hydrochloride is very soluble in water. Metoclopramide Base is practically insoluble in water.
Metoclopramide Hydrochloride in IP, BP, Ph.Eur and USP grades, and Metoclopramide Base in Ph.Eur and BP grades, each with a Certificate of Analysis against the monograph ordered.
The site holds ISO 9001:2015 certification, WHO-GMP and Metoclopramide Hydrochloride is covered by a CDSCO Written Confirmation for export to the EU.
State the form (hydrochloride or base), the grade, the quantity and the destination market. A quotation, specification sheet and typical CoA follow, and a sample can be sent for your own testing before you order.
Request a Quotation
Send the form, pharmacopoeial grade, quantity and destination country, and say whether you need regulatory documentation beyond the CoA. You will get a quotation, the current specification sheet and a typical Certificate of Analysis. Use the contact page or write to info@bio-synth.com.
Other molecules made on the same site are listed under APIs manufactured by Bio-Synth.