Oral liquids · Contract manufacturing enquiry

Sodium Picosulphate 5 mg / 5 ml · Syrup

Discuss third-party manufacturing with Walter Healthcare, India. Confirm the formulation, syrup presentation, packaging and project requirements for a product-specific quotation.

Catalogue reference: WH-1654
Composition and strength: Sodium Picosulphate 5 mg / 5 ml
Dosage form: Syrup
Indicative administration route: Oral
Therapeutic navigation area: Gastroenterology & hepatology
Pharmacological class: Gastrointestinal agent
Manufacturing stream: Non-beta-lactam

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 Sodium Picosulphate 5 mg / 5 ml Syrup. 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

Sodium picosulfate

Reference for: Sodium Picosulphate. Source presentation: ORAL SOLUTION. Source route: oral.

Mechanism of action

Colonic bacteria convert sodium picosulfate to its active diphenol. This locally acting substance stimulates intestinal mucosa and motility.

Pharmacokinetics

The cited oral reference describes passage to the colon with little absorption, followed by local bacterial activation. Only small quantities become systemically available, and plasma concentrations of the active diphenol do not track the laxative effect. The reported 6–12 hour onset reflects local activation rather than a plasma half-life. These findings do not establish the kinetics of a bowel-preparation combination.

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: Kent Pharma: sodium picosulfate oral solution, SmPC sections 5.1–5.2

Reference accessed 2026-10-06. Label revision: 2020--0-3-.

Manufacturing & packaging brief

Plan the syrup presentation.

Use this preparation guide for Sodium Picosulphate 5 mg / 5 ml Syrup. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Specify the ingredient amounts per stated volume and the separate bottle fill volume. Identify flavour, colour and ingredient exclusions as requirements for review.

Quality & technical transfer

Agree the formula, analytical methods and applicable physical and microbiological specifications. Confirm the basis for any proposed storage or label statement.

Review the technical documents

Packaging configuration

Describe the bottle, closure and measuring cup, spoon or syringe. Ask for the container and measuring accessory to be assessed with the formulation.

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Details to confirm for this record

Salt and strength wording: Confirm whether the stated amount refers to the named salt, hydrate or equivalent active moiety. Use the agreed expression consistently in the specification, quotation and artwork.
Concentration and pack size: The record includes a concentration or percentage expression. Confirm its complete basis, then specify the finished fill volume or weight separately. Do not treat pack size as the strength.

Quantities, MOQ & lead time

For Sodium Picosulphate 5 mg / 5 ml Syrup, state the bottle count and fill volume, 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

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

Common questions

Before you request a quotation.

Sodium Picosulphate 5 mg / 5 ml Syrup

What is listed in the catalogue?

The catalogue lists Sodium Picosulphate 5 mg / 5 ml as syrup in its gastroenterology & hepatology navigation area and non-beta-lactam manufacturing stream.

Is manufacturing availability confirmed?

No. Walter checks current facility permissions, formulation and equipment fit, testing, packaging and target-market requirements before written confirmation.

What do I need for a quotation?

Share the exact composition and strength, syrup 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.

Can I change the pack or target market?

Include each proposed pack and country in the enquiry. Container compatibility, artwork, supporting stability evidence, permission scope and destination requirements need review for the requested configuration.

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 Sodium Picosulphate 5 mg / 5 ml Syrup 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 6 October 2026.