Sterile injectables · Contract manufacturing enquiry

Ferric Carboxymaltose 50 mg/ml · Liquid injectables

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

Catalogue reference: WH-1870
Composition and strength: Ferric Carboxymaltose 50 mg/ml
Dosage form: Liquid injectables
Indicative administration route: Parenteral
Therapeutic navigation area: Haematology & thrombosis
Pharmacological class: Haematology 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 Ferric Carboxymaltose 50 mg/ml Liquid injectables. 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 ↗

Prescribing-label excerpts

Ferric Carboxymaltose

Reference for: Ferric Carboxymaltose. Source presentation: injection, solution. Source route: intravenous.

Mechanism of action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

Pharmacokinetics

After administration of a single dose of Injectafer of 100 to 1,000 mg of iron in iron deficient adult patients, maximum iron concentration of 37 µg/mL to 333 µg/mL were obtained respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was estimated to be 3 L.

The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours. Renal elimination of iron was negligible.

After administration of a single dose of Injectafer 15 mg/kg in pediatric patients 1-17 years of age, the maximum concentrations ranged between 124 and 418.1 μg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life of Injectafer in pediatric patients was approximately 9.7 hours. The total median 72-hour exposure (AUC0-72h) after a single dose of Injectafer 15 mg/kg in pediatric patients was 4,529.7 μg∙h/mL while the median exposure after a single dose of 1,000 mg in adults was 5,875.3 μg∙h/mL.

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: Ferric Carboxymaltose — injection, solution

Reference accessed 2026-10-06. Label revision: 2026-08-19.

Manufacturing & packaging brief

Plan the liquid-injectable presentation.

Use this preparation guide for Ferric Carboxymaltose 50 mg/ml Liquid injectables. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Confirm concentration, fill volume, route and whether the proposed container is single-dose or multidose. Identify the formulation and transfer information available.

Quality & technical transfer

Ask for review of the sterile-process strategy, applicable sterility, endotoxin and particulate controls, analytical methods and container-closure integrity requirements.

Review the technical documents

Packaging configuration

Specify ampoule, vial or other proposed container, contact materials, closure and secondary pack. Confirm equipment and facility fit for that configuration.

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Details to confirm for this record

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 Ferric Carboxymaltose 50 mg/ml Liquid injectables, state the container 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

Build the right manufacturing brief.

Dosage-form capabilitiesSterile injectables Therapeutic navigationHaematology & thrombosis Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Ferric Carboxymaltose 50 mg/ml Liquid injectables

What is listed in the catalogue?

The catalogue lists Ferric Carboxymaltose 50 mg/ml as liquid injectables in its haematology & thrombosis 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, liquid injectables 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 Ferric Carboxymaltose 50 mg/ml Liquid injectables 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.