Suppliers and packagers for evomela

evomela

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	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155	NDA	Acrotech Biopharma Inc	72893-001-01	1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL	2016-03-31

Evomela (melphalan hydrochloride) Suppliers and Contract Manufacturers: Who Makes It, Who Sources Key Materials, and What IP/Regulatory Constraints Shape Supply

Last updated: May 29, 2026

Evomela is a branded, injectable melphalan hydrochloride indicated for high-dose chemotherapy with hematopoietic stem cell rescue in eligible settings. The supplier landscape is shaped by (1) FDA manufacturing/CMC approvals for the specific dosage form, (2) control of sterile sterile-manufacturing capacity for cytotoxic oncology injectables, and (3) the Orange Book patent estate and any exclusivity that delays AB-rated generic substitution.

Who are the suppliers of Evomela (melphalan hydrochloride) in the supply chain?

Featured snippet answer: Evomela’s supply depends on the labeled manufacturer(s) of record on the FDA product label and the underlying sterile manufacturing and drug substance supply chain tied to the FDA-approved NDA/CMC package.

Drug product (finished sterile injection) manufacturing

Evomela’s “manufacturer” and “distributed by” language on the FDA label identifies the parties responsible for sterile drug product release and distribution. Those label-disclosed entities are the first-order “suppliers” for procurement planning.

Drug substance sourcing and procurement

Melphalan hydrochloride drug substance procurement typically involves a small number of qualified suppliers capable of producing halogenated cytotoxic small molecules under GMP controls, with secure supply chains and validated impurity profiles matching the approved drug substance specifications.

Contract manufacturing constraints for cytotoxic injectables

Key procurement-relevant constraints that limit qualified supply options for Evomela-type sterile oncology products:

• containment and segregation for cytotoxics
• validated aseptic processing lines and sterility assurance
• supply continuity for melphalan hydrochloride drug substance
• high-quality standards for corrosion control, leachables/extractables, and container-closure integrity for injectable presentations

Which companies supply melphalan hydrochloride drug substance used to make Evomela?

Featured snippet answer: The melphalan hydrochloride “used to make Evomela” is supplied by drug substance vendors approved/qualified within the Evomela NDA’s CMC framework, but the label does not always expose the named raw material vendor(s).

What to expect in the melphalan HCl supplier set

For melphalan hydrochloride:

• drug substance vendors must pass NDA-relevant qualification steps (specs, analytical methods, stability data, comparability if changes occur)
• finished product sterile manufacturing requires validated handling for cytotoxic drug substance characteristics

How to map drug substance suppliers to finished product manufacturing

Procurement teams typically map suppliers by:

• analyzing the Evomela label “manufactured by” entity for product CMO involvement
• checking corporate histories of sterile CMO operations that handle cytotoxic injectables
• tracking CMC supplements and manufacturing site change approvals that can imply qualified alternates

What does the Evomela FDA label say about manufacturers and distributors?

Featured snippet answer: The FDA label identifies the manufacturer of record for Evomela and the distribution entity; those are the practical procurement “suppliers” for customers.

Label-derived fields that drive supplier selection

Procurement-relevant label lines typically include:

• “Manufactured for” or “Manufactured by” (drug product site)
• “Distributed by”
• storage, handling, and packaging that can limit which warehouses can stock/ship

What is the Orange Book status of Evomela and how does it affect supply from generics?

Featured snippet answer: Evomela’s Orange Book listing(s) and any exclusivity periods affect whether competitors can launch AB-rated products and how quickly supply can diversify post-expiration.

How Orange Book listings change supplier dynamics

• If Evomela has unexpired patents listed for the drug product and/or method claims, generic supply is delayed.
• If a competitor successfully challenges via Paragraph IV, generic supply may start at risk under a litigation/settlement framework.

Where supplier risk shows up

For customers trying to dual-source:

• unexpired exclusivity raises “single-source” exposure
• patent settlements can lock in timing and exclusivity terms that delay additional supply

Which generic or biosimilar players could supply melphalan hydrochloride injectables if Evomela’s exclusivity ends?

Featured snippet answer: Generic injectables that match the FDA-approved formulation and strengths can potentially supply melphalan HCl injectables once patents/exclusivity permit. Supplier diversity increases if multiple ANDA approvals become effective.

How Paragraph IV litigation changes the competitive supplier field

Patent challenges can lead to:

• delayed FDA approval implementation until forfeiture or settlement terms expire
• launch at risk (short-term availability volatility)
• manufacturing site constraints if challengers rely on alternate sterile CMO capacity

What patent estate components can block alternative supply of Evomela (product, method, and formulation)?

Featured snippet answer: Evomela’s patent estate (if listed for the NDA) can include drug product/formulation claims, manufacturing process claims, and method-of-use claims that collectively constrain “workaround” supply.

Procurement-relevant IP categories

• composition/formulation patents (can constrain different excipient or container strategies)
• manufacturing/process patents (can constrain alternate sterile manufacturing routes)
• method-of-use patents (less directly relevant to supplier substitution if drug substance/product remains same, but can constrain label changes)

Which manufacturing site changes for Evomela are FDA-approved, and can they widen the supplier base?

Featured snippet answer: FDA approvals for CMC supplements that add manufacturing sites can broaden supply options, but only within the approved NDA framework.

What to watch in CMC history

• approvals for additional sterile fill-finish sites
• post-approval changes in drug substance suppliers
• packaging and container-closure changes that may affect distribution

How do licensing and distribution deals affect who supplies Evomela in practice?

Featured snippet answer: Distribution entities on the label determine the direct procurement interface for many customers, while licensing/CMO arrangements determine the upstream manufacturing capacity.

Common deal structures in sterile oncology injectables

• NDA holder licenses manufacturing to a CMO with dedicated lines
• distributor agreements for regional logistics and inventory management
• vendor-managed inventory contracts for hospitals and specialty channels

What evidence exists for contract manufacturing of Evomela-type injectable oncology products?

Featured snippet answer: Contract manufacturing is common for sterile oncology products, but the specific CMO name must be tied to the FDA label/manufacturer-of-record language or NDA CMC filings.

Procurement signals of CMO involvement

• manufacturer-of-record is different from the “company” associated with the brand
• sterile fill-finish and packaging are performed at a specialized aseptic site with oncology cytotoxic capability
• manufacturing site additions occur via CMC supplements

Key takeaways

• “Supplier” for Evomela in a procurement or supply-risk context starts with the FDA label’s manufacturer of record and distributor entities.
• Upstream “drug substance suppliers” are constrained to those qualified within the Evomela NDA CMC framework; the publicly visible name set may be limited.
• Orange Book status and any exclusivity or patent litigation affect whether alternative manufacturers/generics can increase supply.
• For cytotoxic sterile injectables, qualified supply is driven by containment, aseptic processing capability, and drug substance specification control.

FAQs

1. Does the Evomela label list the drug product manufacturer and distributor differently by country or package size?
2. Can hospitals source Evomela directly from manufacturers or only through wholesalers/distributors?
3. Are melphalan hydrochloride sterile injectables interchangeable with Evomela under FDA labeling and substitution rules?
4. What indicators show whether Evomela’s supply is capacity-constrained by sterile fill-finish rather than drug substance availability?
5. How quickly can generic melphalan hydrochloride injectables enter the market after patent expiry versus settling Paragraph IV disputes?

References

1. FDA. Evomela (melphalan hydrochloride) Prescribing Information and label (latest revision). U.S. Food and Drug Administration. (Accessed 2026-05-29).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-05-29).