Oral solids · Contract manufacturing in India

Itopride 150 mg (SR) · Hard-gelatin capsules

Discuss third-party manufacturing of Itopride 150 mg (SR) Hard-gelatin capsules with Walter Healthcare, India. Share your target market, required capsule count and finished-pack count, packaging and launch timeline for a product-specific quotation.

Catalogue reference: WH-5013
Composition and strength: Itopride 150 mg (SR)
Dosage form: Hard-gelatin capsules
Indicative administration route: Oral
Therapeutic navigation area: Gastroenterology & hepatology
Pharmacological class: Gastrointestinal prokinetic
Manufacturing stream: Non-beta-lactam
BCS class: Class I

Catalogue details support an initial B2B discussion. Walter confirms the applicable unit, current licence scope, formula, target market and commercial feasibility before making a commitment.

Clinical reference

Mechanism and pharmacokinetics.

Explore the published evidence for the ingredients in Itopride 150 mg (SR) Hard-gelatin capsules. Each reference identifies its source formulation and study context. Ingredient studies describe the named reference product; they do not establish the pharmacokinetics, clinical suitability or bioequivalence of this finished formulation.

How to read our product information and sources ↗

Ingredient-level reference

Itopride

Reference for: Itopride. Source presentation: IMMEDIATE-RELEASE TABLET. Source route: oral.

The cited studies use standard-release immediate-release tablet. The catalogue entry has a different or unspecified release description; these study values do not establish its absorption profile.

Mechanism of action

Itopride combines dopamine D2 receptor antagonism with acetylcholinesterase inhibition. Increased acetylcholine activity supports gastric motility and gastric emptying.

Pharmacokinetics

The immediate-release reference describes rapid gastrointestinal absorption, approximately 60% relative bioavailability and a peak 0.5–0.75 hours after 50 mg. Plasma protein binding is about 96%. Hepatic FMO3 metabolism forms an N-oxide; urinary recovery after the cited dose was 3.7% unchanged drug and 75.4% N-oxide. Terminal half-life is approximately 6 hours. Animal tissue-distribution findings are not human measurements, and these data do not establish sustained-release kinetics.

Ingredient-level summary of the cited reference product. Study formulation, route, strength and population govern interpretation; these data do not establish pharmacokinetics or bioequivalence for Walter's formulation or fixed combination.

Source: Malaysia NPRA: itopride hydrochloride 50 mg immediate-release tablets, sections 5.1–5.2

Reference accessed 2026-10-06.

Manufacturing & packaging brief

Plan the hard-capsule presentation.

Use this preparation guide for Itopride 150 mg (SR) Hard-gelatin capsules. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Confirm the fill type, shell material, capsule size and printing requirements. Distinguish powder, granule and pellet fills where relevant to the proposed formulation.

Quality & technical transfer

Request review of the fill specification, shell compatibility, analytical methods and applicable release testing. Identify any established formula or transfer package.

Review the technical documents

Packaging configuration

Specify capsules per blister or bottle, the proposed barrier material and carton configuration. Include shell and print requirements in the quotation scope.

Explore packaging options

Details to confirm for this record

Release presentation: The catalogue includes “SR”. Carry that designation into the RFQ and confirm the intended release specification and supporting evidence; a different release type needs its own assessment.
Concentration and pack size: The record does not state a complete concentration basis. Confirm the amount per volume or weight before a specification, label or quotation is finalised; no denominator has been assumed here.

Quantities, MOQ & lead time

For Itopride 150 mg (SR) Hard-gelatin capsules, state the capsule count and finished-pack count, target market and reorder forecast. MOQ and lead time depend on the assessed formula, process, components, testing and project readiness; request those terms in writing.

Discuss this manufacturing brief

Explore the context

Build the right manufacturing brief.

Dosage-form capabilitiesOral solids Therapeutic navigationGastroenterology & hepatology Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Itopride 150 mg (SR) Hard-gelatin capsules

What is listed in the catalogue?

The catalogue lists Itopride 150 mg (SR) as hard-gelatin capsules in its gastroenterology & hepatology navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Itopride 150 mg (SR) Hard-gelatin capsules. The team reviews the applicable product permission and unit, formulation and equipment fit, testing, packaging and production schedule before confirming the manufacturing scope in writing. Request the relevant product and facility documents with your enquiry.

What do I need for a quotation?

Share the exact composition and strength, hard-gelatin capsules presentation, target market, initial quantity, preferred pack and timing. Identify whether this is a new product, development brief or transfer.

The quotation must confirm MOQ, inclusions, prerequisites and lead time for the proposed product and site.

What is needed for Indian and export markets?

For India, share the intended brand or institutional supply requirement, pack sizes, initial order quantity and artwork needs for Itopride 150 mg (SR) Hard-gelatin capsules. Confirm the applicable product permission, manufacturing unit and labelling requirements with the team.

For export, identify each destination country, proposed pack, language and registration or dossier requirements. Ask which product-specific quality and stability documents are available. Container compatibility and destination-market requirements need review; a catalogue record does not establish export registration or a shelf-life commitment.

How do I submit my enquiry?

Use the product-specific enquiry button to carry this composition and dosage form into the form. After a successful submission, a receipt reference confirms that your brief has been saved for review. Use the RFQ checklist to prepare the remaining details.

Technical document review

Which documents can I ask Walter to review?

Ask about manufacturing and packing records, specifications, analytical methods, Certificates of Analysis (COA), stability evidence, the Process Validation Protocol (PVP) and Process Validation Report (PVR). The wider checklist below covers supplier qualification, technical transfer and ongoing supply.

View the full document checklist 14 review areas

Site, licence and audit scope: Manufacturing licence, applicable product permissions, GMP certificates, Site Master File, supplier-qualification questionnaire and relevant audit responses.
Manufacturing, packing and batch release: Master Formula Record (MFR), master packing instructions, Batch Manufacturing Record (BMR), Batch Packing Record (BPR), reconciliation and authorised release records.
Process validation and continued verification: Process Validation Protocol (PVP), Process Validation Report (PVR), process performance qualification documents and continued process verification trends.
Equipment, facilities and utilities: Validation Master Plan (VMP), user requirements, DQ/IQ/OQ/PQ records, calibration and maintenance evidence for relevant equipment and utilities.
Cleaning, carryover and hold times: Cleaning Validation Protocol (CVP), Cleaning Validation Report (CVR), residue limits, recovery studies and applicable clean, dirty and process hold-time studies.
Specifications and analytical evidence: Specifications, Method of Analysis (MOA), Standard Testing Procedure (STP), Certificates of Analysis (COA), analytical validation, verification and method-transfer records.
Stability, packaging and transport: Stability protocols/reports, ongoing stability commitments, pack specifications, approved artwork, compatibility and applicable packaging or transport studies.
Development and technology transfer: Development report, technology-transfer protocol/report, gap assessment, control strategy, critical quality attributes and critical process parameters.
Quality reviews, investigations and changes: Product Quality Review (PQR) / Annual Product Review (APR), deviations, CAPA, change control, OOS/OOT trends, complaints, recalls and relevant SOP/training records.
Material suppliers and impurity risks: API/excipient supplier qualification, traceability, material COAs, relevant origin declarations and impurity risk assessments with supporting tests.
Sterile-product evidence, where applicable: Contamination Control Strategy (CCS), media-fill/aseptic simulation reports, sterilisation and filtration validation, environmental monitoring, sterility/endotoxin and container-closure integrity evidence.
Computerised systems and data integrity: Computerised-system validation, access controls, audit-trail review, backup/restore checks and relevant data-integrity procedures.
Market-specific regulatory support: Applicable dossier sections, API master-file/CEP support, bioequivalence or biowaiver evidence and Certificate of a Pharmaceutical Product (CPP/CoPP), where required and available.
Quality agreement and access arrangements: Quality/technical agreement covering responsibilities, release, changes, subcontracting, investigations, complaints, recalls, audits and document access.

Agree the list for the exact product, site, process, pack, market and project stage. QA confirms what exists, applies and may be shared; some records may require an NDA, redaction or controlled review. See document definitions and review guidance.

Important qualification

This B2B catalogue record is not proof of current approval or confirmation that Itopride 150 mg (SR) Hard-gelatin capsules is available for sale. It is not prescribing information or patient advice. Any Drugs Rules status, current approval, exemption, applicable unit, licence scope, formulation, claims, brand use, destination-market registration and commercial feasibility require documentary verification and Walter's written confirmation. Read the full regulatory disclaimer.

Composition and classification are taken from Walter's product catalogue. The manufacturing guide helps buyers prepare a technical brief. Clinical references, where shown, describe the cited product and study. Manufacturing guide updated 8 October 2026.