Suppliers and packagers for generic pharmaceutical drug: DACTINOMYCIN

DACTINOMYCIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-431-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-03-15
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-928-02	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-03-15
Hisun Pharm Hangzhou	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	207232	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-008-01	1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2024-05-08

Suppliers and packagers for generic pharmaceutical drug: DACTINOMYCIN

Last updated: May 25, 2026

DaCTINOMYCIN suppliers: API and contract manufacturing landscape, key vendors, and sourcing routes

Executive summary: Suppliers of dactinomycin fall into two lanes: (1) commercial API/finished-dose supply controlled by a small number of manufacturers because the molecule is older, supply chains are tightly managed, and oncology demand is concentrated; (2) specialty/compounding and hospital distribution networks that stock injectable vials and manage cold-chain and sterile handling. Publicly available supplier lists and reseller inventories exist, but reliable, litigation-ready sourcing typically requires confirmation from the specific ANDA/NDA label holder, CMO/sterile manufacturer, and the distributor of record on the branded or generic product carton.

Who sells dactinomycin injection and where are the common supply channels?

Answer (high level): Dactinomycin is sold primarily as sterile injectable vials through brand/generic distributors that serve oncology treatment centers and hospital pharmacies. For acquisition, buyers typically use either:

• Wholesalers/distributors of record for the specific labeled NDC
• Specialty pharmaceutical distributors that handle high-acuity oncology products
• Direct purchase from licensed manufacturers for institutional volumes (usually via procurement frameworks)

What are typical product forms supplied for dactinomycin?

• Sterile lyophilized powder or solution for intravenous (IV) use depending on the marketed presentation
• Vial-based single-dose packaging intended for dilution under sterile technique

Which purchasing routes dominate institutional procurement?

• NDC-level sourcing through group purchasing organizations (GPOs), then distributor fulfillment
• Emergency supply routing through multiple wholesalers when allocation occurs
• Distributor-managed recall and lot tracking for controlled oncology injectable handling

What companies supply dactinomycin active pharmaceutical ingredient (API)?

Answer: Dactinomycin API is a narrow, specialist-supply segment. Sourcing is generally concentrated in manufacturers that produce complex antibiotics/oncology cytotoxics under GMP with validated impurity profiles and tight sterile and containment controls during manufacture and packaging.

API supply constraints that affect supplier availability

• Complex molecular handling for a cytotoxic antibiotic
• High regulatory scrutiny on impurity profile, residual solvents, and microbial controls
• Demand volatility tied to cancer treatment protocols and clinician prescribing patterns
• Contract manufacturing capacity in sterile oncology and packaging lines

How to identify the correct API supplier for a given finished product

A finished vial’s manufacturing chain often separates:

• API manufacturer (upstream)
• Finished-dose manufacturer (sterile fill-finish)
• Labeler/distributor (market authorization and commercial supply)

Procurement teams typically map suppliers by NDC labeler, then trace:

• FDA drug listing and label manufacturing/packager statements
• Inspection history tied to sterile manufacturing sites
• Lot traceability in batch documentation

What finished-dose manufacturers make dactinomycin injectable under GMP sterile conditions?

Answer: Dactinomycin injectable is typically made by companies with sterile cytotoxic fill-finish capabilities. Buyers should treat “supplier” as either:

• the finished-dose manufacturer on the label, or
• the distributor of record for the NDC they plan to buy

Sterile manufacturing risk points that affect supplier performance

• Aseptic fill-finish line readiness for cytotoxic antibiotics
• Environmental monitoring and contamination control for sterile injectables
• Validated cleaning/segregation procedures due to cytotoxic containment
• Allocation policies during line downtime

How does dactinomycin supplier selection change by country or region?

Answer: Supplier lists vary by geography because availability depends on local:

• market authorization status for the specific NDC/presentation
• distributor network coverage for oncology injectables
• licensing and labeling requirements

Common regional sourcing patterns

• US: tends to rely on FDA-approved labelers and wholesaler distribution for NDC-level purchasing
• EU/UK: typically uses centralized marketing authorization labeling and national wholesalers
• Emerging markets: more variability in distributor networks and product presentation availability

What role do distributors, wholesalers, and group purchasing organizations play in dactinomycin supply?

Answer: Distributors control day-to-day access for hospitals and oncology clinics, while wholesalers control broad accessibility across many customer accounts.

Procurement reality for oncology injectables

• Hospital purchasing often uses GPO contracts
• Non-contract supply can be accessed through specialty distributors
• Allocation events typically trigger cross-network sourcing and expedited procurement

Which suppliers are most relevant for licensing, tendering, and batch qualification?

Answer: For licensing, tenders, and qualifying alternative sources, the relevant entities are:

1. the finished-dose manufacturer listed on the product label (sterile site)
2. the API manufacturer named via documentation or traceability
3. any CMO/packager performing sterile fill-finish or packaging
4. the distributor of record for contractual supply

Qualification artifacts that buyers usually require

• CoA by lot with impurity profile and potency
• GMP certificates for the manufacturing sites
• Validation/compatibility data for dilution and IV use (label-based)
• Lot traceability and recall procedures

What generic or alternative dactinomycin product supply risks exist?

Answer: The primary risks are not “generic-to-generic” substitution risks alone, but product availability risk from limited production capacity and the complexity of sterile cytotoxic handling.

Typical risk drivers

• Sterile manufacturing line constraints
• Limited number of suppliers for API and sterile fill-finish
• Quality incidents that stop shipment while corrective actions are completed

What is the supplier due diligence checklist for dactinomycin?

Answer: Buyers should qualify suppliers at three levels: molecule quality (API), sterile product quality (finished-dose site), and commercial reliability (distributor and fulfillment).

Due diligence items

• Verify manufacturing sites and batch responsibility in documentation
• Confirm aseptic controls and cytotoxic containment procedures at sterile fill-finish
• Require lot-level CoA and test acceptance criteria
• Confirm packaging integrity, labeling accuracy, and tamper-evidence
• Validate supply continuity (lead times, allocation policy)

Key Takeaways

• Dactinomycin supply is concentrated, and buyer “supplier” should mean the NDC-level finished-dose labeler/manufacturer plus the distributor of record.
• API sourcing is a narrow lane dominated by specialist manufacturers; finished-dose sterile fill-finish is typically the operational bottleneck.
• For procurement, licensing, and qualification, map the chain: API maker → sterile fill-finish/packager → labeler/distributor using label language and lot traceability.
• Supplier reliability depends more on sterile capacity and cytotoxic handling controls than on typical commodity pharmaceutical supply dynamics.

FAQs

1. How do hospitals qualify an alternate source for dactinomycin injection during allocation?
2. What documents are required to validate a new dactinomycin vendor for oncology pharmacy procurement?
3. Does dactinomycin supply differ for different vial presentations or label strengths?
4. What is the fastest sourcing strategy when dactinomycin vials go on backorder?
5. How should procurement teams handle lot traceability and recalls for dactinomycin?

References

1. U.S. Food and Drug Administration (FDA). Drug Products (Orange Book, when applicable) and prescribing information databases.
2. FDA. Drug Registration and Listing System (DRLS) and label/labeler information.
3. FDA. Current Good Manufacturing Practice (cGMP) and sterile drug product guidance materials.