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Oral solids · Contract manufacturing enquiry

Ambroxol 30 mg, Doxofylline 400 mg Tablets

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

Catalogue reference
WH-0115
Composition and strength
Ambroxol 30 mg, Doxofylline 400 mg
Dosage form
Tablets
Indicative administration route
Oral
Therapeutic navigation area
Respiratory & allergy
Pharmacological class
Bronchodilator
Manufacturing stream
Non-beta-lactam
BCS class
Class III (mixed)

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 Ambroxol 30 mg, Doxofylline 400 mg Tablets. 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

Doxofylline

Reference for: Doxofylline. Source presentation: TABLET. Source route: oral.

Mechanism of action

Doxofylline is a xanthine derivative that relaxes bronchial smooth muscle. The reference reports little activity at the tested adenosine receptors and phosphodiesterase subtypes, so theophylline's mechanism should not simply be assigned to it.

Pharmacokinetics

The oral-tablet studies summarized in the reference report a plasma peak around 1 hour, approximately 62.6% absolute bioavailability and about 48% protein binding. Hepatic metabolism accounts for most clearance; less than 4% of an oral dose is recovered unchanged in urine. During repeated treatment the reported half-life was 8–10 hours, with steady state around day 4. Single-dose intravenous findings in the same label are different.

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: Puroxan doxofylline 400 mg prescribing information, September 2023

Reference accessed . Label revision: 2023--0-9.

Ingredient-level reference

Ambroxol

Reference for: Ambroxol. Source presentation: IMMEDIATE-RELEASE ORAL FORM. Source route: oral.

Mechanism of action

Ambroxol is a bromhexine metabolite with secretolytic and secretomotor activity described in the oral-solution product information. Its full mechanism is not completely established. The separate HPRA lozenge reference also describes sodium-channel blockade in laboratory studies, a mechanism related to local anesthetic activity.

Pharmacokinetics

The oral-reference studies summarized by HPRA report peak plasma levels after approximately 1–2.5 hours for immediate-release ambroxol, protein binding of about 90% and a terminal half-life of about 10 hours. Metabolism occurs mainly in the liver, including glucuronidation and CYP3A4-mediated pathways. Lozenge, syrup and modified-release formulations can produce different exposure.

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: HPRA: Lysopadol ambroxol product information, with oral PK reference studies

EFDA: ambroxol oral-solution SmPC, pharmacodynamic properties

Reference accessed .

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Ambroxol 30 mg, Doxofylline 400 mg Tablets. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Define release type, coating, scoring and any reference-product requirements. Keep each strength and presentation as a separate item in the brief.

Quality & technical transfer

Agree the product specification, analytical methods and applicable dissolution or disintegration requirements. Identify the formula and process information available for transfer.

Review the technical documents

Packaging configuration

Compare the proposed blister, strip or bottle with the formulation and its protection requirements. Specify tablets per primary pack and primary packs per carton.

Explore packaging options

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.

Quantities, MOQ & lead time

For Ambroxol 30 mg, Doxofylline 400 mg Tablets, state the tablet 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 solidsTherapeutic navigationRespiratory & allergyFull catalogueSearch other compositions

Related catalogue records

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

Common questions

Before you request a quotation.

Ambroxol 30 mg, Doxofylline 400 mg Tablets

What is listed in the catalogue?

The catalogue lists Ambroxol 30 mg, Doxofylline 400 mg as tablets in its respiratory & allergy 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, tablets 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 Ambroxol 30 mg, Doxofylline 400 mg Tablets 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 .