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Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension

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

Catalogue reference
WH-1714
Composition and strength
Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml
Dosage form
Oral suspension
Indicative administration route
Oral
Therapeutic navigation area
Pain & musculoskeletal care
Pharmacological class
Analgesic & antipyretic
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 Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension. 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.

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Prescribing-label excerpts

Acetaminophen / Ibuprofen

Reference for: Ibuprofen; Paracetamol. Source presentation: tablet, film coated. Source route: oral.

Mechanism of action

Analgesia — COMBOGESIC contains acetaminophen and ibuprofen.

Acetaminophen is a non-opiate, non-salicylate analgesic. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to primarily involve central actions. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Its mechanism of action for analgesia, like that of other NSAIDs, is not completely understood, but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Pharmacokinetics

Absorption — Peak plasma concentration following the administration of three COMBOGESIC tablets occurs at approximately 45 minutes and 1 hour 15 minutes after administration for acetaminophen and ibuprofen, respectively, under fasting condition. In the same study, the peak plasma concentration (Cmax) and the extent of absorption (AUC0-inf) are 14.88 mcg/mL and 47.44 mcg.h/mL for acetaminophen and 25.58 mcg/mL and 95.62 mcg.h/mL for ibuprofen, respectively. The Cmax and AUC0-inf values for both acetaminophen and ibuprofen increase dose proportionally to increases in COMBOGESIC doses from one, to two, to three tablets. A single-dose pharmacokinetic study of COMBOGESIC in volunteers showed no drug interactions between acetaminophen and ibuprofen.

Distribution — Acetaminophen appears to be widely distributed throughout most body tissues except fat. Its apparent volume of distribution is about 0.9 L/kg. A relatively small portion (~20%) of acetaminophen is bound to plasma protein.

Elimination — The half-life of acetaminophen is about 2 to 3 hours in adults. It is somewhat shorter in children and somewhat longer in neonates and in cirrhotic patients. Acetaminophen is eliminated from the body primarily by formation of glucuronide and sulfate conjugates in a dose-dependent manner.

Ibuprofen is rapidly metabolized and eliminated in the urine. The elimination half-life of ibuprofen is in the range of 1.9 to 2.2 hours.

Selected passages from the cited U.S. prescribing label. The studies concern the source product and populations named in each passage; they do not establish Walter-product bioequivalence, an approved indication, or the kinetics of another fixed combination. Tables and the full prescribing information remain available in the source.

Source: DailyMed: Acetaminophen / Ibuprofen — tablet, film coated

Reference accessed . Label revision: 2025-01-14.

Manufacturing & packaging brief

Plan the oral-suspension presentation.

Use this preparation guide for Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Clarify whether the requirement is a ready-to-use suspension or a powder for reconstitution. Provide concentration, final volume and formula details for the requested presentation.

Quality & technical transfer

Request review of the applicable suspension specification, analytical methods and measuring accuracy. Reconstitution and in-use statements need their own supporting evidence where relevant.

Review the technical documents

Packaging configuration

Specify bottle capacity, fill or reconstitution volume, closure and measuring device. List any diluent or accessory separately in the brief.

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Details to confirm for this record

Full composition
Keep all named components and their individual amounts together in the specification. Ingredient substitutions, omissions and changed ratios require a separate formula and permission review.
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 Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension, state the bottle count and finished 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.

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Related catalogue records

Grouped by catalogue navigation labels, not by therapeutic interchangeability or clinical recommendation.

Common questions

Before you request a quotation.

Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension

What is listed in the catalogue?

The catalogue lists Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml as oral suspension in its pain & musculoskeletal care 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, oral suspension 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 Ibuprofen 100 mg, Paracetamol 162.5 mg / 5 ml Oral suspension 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 .