Oral solids · Contract manufacturing enquiry

Flupirtine Maleate 400 mg (SR) Uncoated · Tablets

Request manufacturing feasibility

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-0781
Composition and strength
Flupirtine Maleate 400 mg (SR) Uncoated
Dosage form
Tablets
Indicative administration route
Oral
Therapeutic navigation area
Pain & musculoskeletal care
Pharmacological class
Musculoskeletal care agent
Manufacturing stream
Non-beta-lactam
BCS class
Class II

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.

Editorial development perspective

What deserves attention in this formulation.

These notes use the catalogue composition and presentation to frame a technical discussion. They are planning considerations, not tested properties or clinical findings for this product.

A matching clinical reference has not yet been verified for this page. Drug-specific mechanisms and human pharmacokinetic values remain open for review.

About these development notes and source limitations ↗

Balance tablet performance and processability

Listed presentation: Tablets.

Use early development batches to compare blend flow, compression behaviour, tablet strength and the appropriate release test. A harder tablet or a faster disintegration result is not, by itself, a complete product specification. Set priorities around the intended presentation, then check that the chosen process can reproduce them at the proposed scale.

Make the release target explicit

Catalogue wording: “SR”.

Define the intended release profile and its test method before choosing a coating, matrix or other formulation approach. Compare prototypes against that target and identify the formulation-specific evidence needed to assess exposure and food effects. A release abbreviation alone does not establish a duration of action, dosing interval or pharmacokinetic profile.

Translate the listed strength into a quantitative formula

Strength expressions in this entry include “400 mg”.

Tie every stated ingredient amount to its intended dosage unit or measure, then distinguish that declared amount from the quantity of raw material needed for a batch. Record any assay or equivalence calculation in the formula. This gives development, purchasing and artwork teams the same strength definition without assigning a patient dose from the catalogue.

Suggested starting point

A practical starting point is to make the release target explicit. For this tablets brief, agree the target characteristics and a short set of measurable development questions before comparing prototypes or supplier proposals. Keep unresolved clinical claims outside the product specification until supporting evidence is available.

Discuss this product brief

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Flupirtine Maleate 400 mg (SR) Uncoated 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 “SR”. 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 Flupirtine Maleate 400 mg (SR) Uncoated 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.

Common questions

Before you request a quotation.

Flupirtine Maleate 400 mg (SR) Uncoated Tablets

What is listed in the catalogue?

The catalogue lists Flupirtine Maleate 400 mg (SR) Uncoated as tablets 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, 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 Flupirtine Maleate 400 mg (SR) Uncoated 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 .