Oral solids · Contract manufacturing in India

Ambroxol 75 mg (CR) · Tablets

Discuss third-party manufacturing of Ambroxol 75 mg (CR) Tablets with Walter Healthcare, India. Share your target market, required tablet count and finished-pack count, packaging and launch timeline for a product-specific quotation.

Catalogue reference: WH-0123
Composition and strength: Ambroxol 75 mg (CR)
Dosage form: Tablets
Indicative administration route: Oral
Therapeutic navigation area: Respiratory & allergy
Pharmacological class: Mucolytic & expectorant
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 Ambroxol 75 mg (CR) 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

Ambroxol

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

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

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 2026-10-06.

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Ambroxol 75 mg (CR) 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

Release presentation: The catalogue includes “CR”. Carry that designation into the RFQ and confirm the intended release specification and supporting evidence; a different release type needs its own assessment.

Quantities, MOQ & lead time

For Ambroxol 75 mg (CR) 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 solids Therapeutic navigationRespiratory & allergy Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Ambroxol 75 mg (CR) Tablets

What is listed in the catalogue?

The catalogue lists Ambroxol 75 mg (CR) as tablets in its respiratory & allergy navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Ambroxol 75 mg (CR) Tablets. 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, 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.

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 Ambroxol 75 mg (CR) Tablets. 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 Ambroxol 75 mg (CR) 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 8 October 2026.