Sterile injectables · Contract manufacturing in India

Dactinomycin 500 mcg · Dry-powder injectables

Discuss third-party manufacturing of Dactinomycin 500 mcg Dry-powder injectables with Walter Healthcare, India. Share your target market, required vial count and amount per vial, packaging and launch timeline for a product-specific quotation.

Catalogue reference: WH-2004
Composition and strength: Dactinomycin 500 mcg
Dosage form: Dry-powder injectables
Indicative administration route: Parenteral
Therapeutic navigation area: Other & specialty products
Pharmacological class: Specialty therapeutic 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 Dactinomycin 500 mcg Dry-powder 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

Dactinomycin

Reference for: Dactinomycin. Source presentation: injection, powder, lyophilized, for solution. Source route: intravenous.

Mechanism of action

Dactinomycin is a cytotoxic actinomycin that binds DNA and inhibits RNA synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.

Pharmacokinetics

The distribution and excretion of radiolabeled dactinomycin (3H actinomycin D) were assessed in three adult patients with malignant melanoma.

Distribution — 3H actinomycin D is concentrated in nucleated cells and does not penetrate the blood-brain barrier.

Excretion — Following administration of radiolabeled dactinomycin, approximately 30% was recovered in urine and feces in one week.

Pediatric Patients — Published studies and population analyses in patients ≤ 21 years of age with cancer report a trend of increasing systemic dactinomycin clearance with increasing body weight.

Drug Interaction Studies — Published in vitro studies report that dactinomycin may be a substrate of the P-glycoprotein and OATP1B3 transporter systems.

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: Dactinomycin — injection, powder, lyophilized, for solution

Reference accessed 2026-10-06. Label revision: 2024-06-18.

Manufacturing & packaging brief

Plan the dry-powder injectable presentation.

Use this preparation guide for Dactinomycin 500 mcg Dry-powder injectables. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Define the amount per container, salt-equivalence wording, route and proposed reconstitution presentation. Confirm the production route; a dry-powder listing alone does not establish lyophilisation.

Quality & technical transfer

Request 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

Provide vial size, stopper, seal and carton requirements. Identify any diluent and administration accessory separately, including their specifications and supply responsibilities.

Explore packaging options

Details to confirm for this record

Exact presentation: Use “Dactinomycin 500 mcg Dry-powder injectables” consistently in the brief. Specify coating, release, grade or other presentation requirements explicitly where the catalogue does not define them.

Quantities, MOQ & lead time

For Dactinomycin 500 mcg Dry-powder injectables, state the vial count and amount per vial, 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 navigationOther & specialty products Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Dactinomycin 500 mcg Dry-powder injectables

What is listed in the catalogue?

The catalogue lists Dactinomycin 500 mcg as dry-powder injectables in its other & specialty products navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Dactinomycin 500 mcg Dry-powder injectables. 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, dry-powder 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.

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 Dactinomycin 500 mcg Dry-powder injectables. 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 Dactinomycin 500 mcg Dry-powder 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 8 October 2026.