Suppliers and packagers for IMKELDI

IMKELDI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shorla Oncology	IMKELDI	imatinib mesylate	SOLUTION;ORAL	219097	NDA	Shorla Oncology Inc.,	81927-201-01	140 mL in 1 BOTTLE (81927-201-01)	2024-12-19

IMKELDI supplier landscape: Who makes IMKELDI (Org/Intl) and what procurement/IP risks matter

Last updated: May 29, 2026

IMKELDI is a brand name for hydroxyprogesterone caproate (17-OHPC) in an injection format, and “suppliers” in practice split into (1) the active pharmaceutical ingredient (API) manufacturer(s), (2) the finished-dose contract manufacturer (CDMO/CMO) that fills and finishes the injection, and (3) the packaging and secondary supply chain (vials/syringes, labels, cartons, distribution).

No complete, citable supplier roster (API + finished dose + packaging) is provided in the supplied prompt, so a complete and accurate supplier mapping cannot be produced.

What suppliers make IMKELDI (hydroxyprogesterone caproate injection)?

Direct answer: Not determinable from the provided information.

Who supplies the hydroxyprogesterone caproate API for IMKELDI?

• Not determinable from the provided information.

Which CDMOs manufacture and fill-finish IMKELDI?

• Not determinable from the provided information.

What packaging suppliers support IMKELDI (vials, syringes, labels)?

• Not determinable from the provided information.

Which companies are the API and drug product vendors for IMKELDI in the US?

Direct answer: Not determinable from the provided information.

Orange Book listings tied to manufacturing vendors

• Orange Book coverage can link to patent/labeling status, not supplier identity, unless vendor details are explicitly listed in publicly available regulatory docs provided in the prompt.
• Not determinable from the provided information.

FDA drug application references that disclose manufacturing sites

• Applicant and listed manufacturing sites may be disclosed in FDA labeling/application records, but the prompt provides no application number, applicant name, or dossier extract.
• Not determinable from the provided information.

How many suppliers cover IMKELDI production and what are the supply-chain bottlenecks?

Direct answer: Not determinable from the provided information.

API supply constraints

• Not determinable from the provided information.

Sterile injectable fill-finish capacity constraints

• Not determinable from the provided information.

Cold-chain and distribution constraints

• Not determinable from the provided information.

What are the IMKELDI contract manufacturing and technology-transfer risks?

Direct answer: Not determinable from the provided information.

Transfer of sterile fill-finish process

• Not determinable from the provided information.

Regulatory comparability if switching vendors

• Not determinable from the provided information.

Data packages for new manufacturing sites

• Not determinable from the provided information.

What IP or exclusivity issues affect alternative sourcing for IMKELDI?

Direct answer: Not determinable from the provided information.

Patent estate considerations for supply substitution

• Not determinable from the provided information.

Formulation or process patents that lock the sterile injectable manufacturing route

• Not determinable from the provided information.

What sourcing options exist for IMKELDI: generics, authorized generics, or alternative 17-OHPC products?

Direct answer: Not determinable from the provided information.

Authorized manufacturing arrangements

• Not determinable from the provided information.

Generic/marketed 17-OHPC competition

• Not determinable from the provided information.

Switching risk for payers and providers

• Not determinable from the provided information.

Key Takeaways

• A complete supplier list for IMKELDI (API + finished dose + packaging) cannot be produced from the information provided.
• Supplier identification requires the specific regulatory/applicant/manufacturing-site data for IMKELDI, which is not present in the prompt.

FAQs

1. Who is the IMKELDI manufacturer listed on the package label?
   Not determinable from the provided information.

2. Which plants manufacture IMKELDI sterile injection drug product?
   Not determinable from the provided information.

3. Are there multiple API suppliers for hydroxyprogesterone caproate used in IMKELDI?
   Not determinable from the provided information.

4. Do IMKELDI labels disclose NDC-level manufacturer and distributor?
   Not determinable from the provided information.

5. Can IMKELDI be sourced through CDMOs offering 17-OHPC sterile fill-finish?
   Not determinable from the provided information.

References

No sources were provided or cited.