Suppliers and packagers for generic pharmaceutical drug: levoleucovorin

levoleucovorin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acrotech Biopharma	KHAPZORY	levoleucovorin	POWDER;INTRAVENOUS	211226	NDA	Acrotech Biopharma Inc	72893-004-01	1 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL	2019-01-02

Suppliers and packagers for generic pharmaceutical drug: levoleucovorin

Last updated: May 30, 2026

LEVOLEUCOVORIN Suppliers: Who Manufactures Levoleucovorin API, Drug Product, and Generic Sources?

Levoleucovorin supply in the market is split between (1) chemical/API manufacturers supplying the active pharmaceutical ingredient, and (2) branded and generic drug-product manufacturers that package levoleucovorin for FDA and global markets. Without a specific NDA/ANDA, dosage form, strength, and country, supplier lists are not determinable to a level suitable for licensing, procurement, or litigation use.

Who supplies levoleucovorin (API) in the US and Europe?

Featured snippet answer: Levoleucovorin API sourcing is largely handled by contract manufacturers and established chemical producers that support branded and generic launches, with country-by-country differences driven by regulatory status and DMF/CEP coverage.

API supply chain components

• Levoleucovorin (active) manufacturing typically depends on chiral chemistry capability and stringent stereoisomer controls.
• Drug-product supply depends on container-closure, sterile vs non-sterile handling (if applicable), and validated dissolution/assay specs.

What supplier signals matter for diligence

• DMF holder(s) for the US market (Type II/III as applicable).
• CEP/EDMF coverage in Europe for API continuity.
• History of FDA inspections tied to the API site and drug-product site.

Which companies sell levoleucovorin drug product (injectable/oral) by NDA or ANDA?

Featured snippet answer: Drug-product suppliers are determined by the labeled NDA/ANDA holder for each strength and dosage form, and by current commercial distribution arrangements with wholesalers and GPOs.

Dose-form-specific supplier mapping

Levoleucovorin can be commercialized in different dosage forms and strengths, which drives different ANDA portfolios and packaging suppliers. Supplier identification must be tied to:

• Labeled strength
• Dosage form
• Route of administration
• FDA label and application (NDA vs ANDA)

Procurement risk points

• Supply continuity hinges on drug-product site inspections and batch release performance.
• Switching suppliers can trigger formulation or manufacturing changes that require bridging documentation.

Are there FDA Orange Book listings for levoleucovorin that identify current ANDA/brand suppliers?

Featured snippet answer: Orange Book listings identify product application holders and patents/exclusivity, which can be used to map drug-product suppliers. Supplier-by-supplier granularity depends on which levoleucovorin product (NDC) is targeted.

Why Orange Book matters for supplier discovery

• ANDA holder names are direct supply-chain nodes.
• Patent and exclusivity status influence the number of parallel approved suppliers.

What generic entry risks exist for levoleucovorin suppliers?

Featured snippet answer: Generic entry risk is linked to FDA approval status of ANDAs, patent barriers (Orange Book-listed patents and exclusivity), and manufacturing/CMC compliance.

Entry constraints that block supplier availability

• Patent infringement risks tied to product and method-of-use claims.
• CMC gaps around particle size, stability, stereochemical purity, and process controls.
• Drug master file dependence that can limit readiness for multiple suppliers.

How do levoleucovorin manufacturer quality systems affect supply stability?

Featured snippet answer: Supply stability correlates with GMP inspection outcomes, validated sterility/aseptic controls (if injectable), and batch-to-batch consistency in potency and stereochemical purity.

Key quality-system checks

• FDA/EMA inspection history by site.
• Quality agreements covering API testing, CoA reliance, and change control.
• Out-of-specurrence and deviation trends tied to release rates.

Which licensors or CMOs can support levoleucovorin production scale-up?

Featured snippet answer: For licensing and scale-up, buyers typically contract with chemical API producers for chiral synthesis and with drug-product CMOs for formulation, fill-finish (if applicable), and packaging.

What to screen in CMO capability

• Chiral chemistry and stereochemical analytics (identity/purity methods).
• Regulatory documentation readiness (DMF capability and audit trail).
• Fill-finish capacity and validated environmental controls (if injectable).

Key Takeaways

• Supplier identification for levoleucovorin must be anchored to a specific labeled product (NDC, dosage form, strength, and application holder) and its FDA application (NDA/ANDA).
• API supply and drug-product supply are separable, and both must be mapped for procurement, licensing, or litigation decisions.
• Orange Book and FDA application data are the primary pathways to defensible supplier lists.

FAQs

1. How can I identify the ANDA holders for levoleucovorin for a specific NDC?
2. What does DMF coverage tell me about levoleucovorin API availability?
3. How do I assess whether a levoleucovorin supplier has sufficient GMP capacity for commercial batches?
4. What documentation should a levoleucovorin supplier provide for change control and batch release?
5. How do patent and exclusivity timelines affect which levoleucovorin suppliers can launch generics?

References

1. US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. US FDA. Drug Master Files (DMF) and related guidance. (Accessed 2026).