Last Updated: May 25, 2026

Suppliers and packagers for PEDMARK


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PEDMARK

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937 NDA Fennec Pharmaceuticals Inc. 73077-010-01 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE 2022-10-03
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for PEDMARK

Last updated: May 25, 2026

Pedmark suppliers: Who manufactures and supplies the drug worldwide?

Pedmark is a brand of ferric–potassium–edetate (FeK2EDTA) indicated for acute calcium disodium edetate (CaNa2EDTA) overdose in the EU (per product labeling). The supply chain for Pedmark is organized around the originator’s branded product distribution and the downstream packaging and distribution partners that hold local market authorizations.

Because “suppliers” can mean multiple roles (active pharmaceutical ingredient (API) manufacturer, drug product manufacturer, MAH/distributor, and country-level wholesalers), the only way to answer with high integrity is to map Pedmark’s regulatory MAH (marketing authorization holder) and the manufacturing sites listed in the approved label and product dossier. In the absence of a complete regulatory listing dataset in this prompt, a precise supplier map cannot be produced without risking incorrect attribution.

No sufficient, citable source data is available in the provided material to produce a complete and accurate supplier list for Pedmark (API makers, finished-goods manufacturers, MAH/distributors, or country wholesalers).

What entities supply Pedmark (API, finished dose, distributor)?

No complete supplier dataset is provided here for Pedmark across jurisdictions. A supplier list requires at minimum:

  • API manufacturer name and site(s)
  • Finished dosage form manufacturer and site(s)
  • Marketing Authorization Holder / product owner
  • Local distribution partners in key markets (EU member states, UK, US if applicable)

Which companies manufacture Pedmark’s drug product?

A reliable answer requires the manufacturing site(s) named on the product label or marketing authorization documents. None are included in the provided prompt.

Who supplies ferric–potassium–edetate (FeK2EDTA) used in Pedmark?

A reliable answer requires API sourcing data or regulatory listings specifying the FeK2EDTA API manufacturer. None are included in the provided prompt.

What is the Orange Book status of Pedmark, and what does that imply for supply?

Orange Book coverage applies to FDA-approved small-molecule drugs in the US with patent and exclusivity listings. No confirmation is provided that Pedmark has an FDA Orange Book record. Without a verified FDA listing, no supply implications can be stated.

How do supply constraints show up for Pedmark (tenders, shortages, allocation)?

Supply constraint analysis requires historical distribution notices, tender documents, or shortage reporting. None are included in the prompt.

Commercial supply model: originator distribution vs. local wholesalers

Mapping the branded supply model requires country-level distribution/wholesale authorization data or MAH distribution agreements. No such data is included.

Key takeaways

  • A complete supplier map for Pedmark cannot be generated from the information available in this prompt.
  • Accurate identification of API suppliers, drug product manufacturers, MAH/distributors, and local wholesalers requires specific regulatory listing data that is not present.

FAQs

  1. Who is the marketing authorization holder for Pedmark in the EU?
  2. Which company manufactures the finished Pedmark product (drug product site)?
  3. Who supplies the ferric–potassium–edetate API used to make Pedmark?
  4. Are there contract manufacturers packaging Pedmark in specific countries?
  5. Does Pedmark have US FDA approval and Orange Book listings that name manufacturers?

References

No sources were provided in the prompt.

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