Last Updated: May 10, 2026

Suppliers and packagers for AMMONIA N 13


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AMMONIA N 13

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
3d Imaging Drug AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203779 ANDA 3D Imaging Drug Design and Development LLC 76451-013-10 10 mL in 1 VIAL, GLASS (76451-013-10) 2012-01-02
Biomedcl Res Fdn AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204352 ANDA Biomedical Research Foundation of Northwest Louisiana 24562-004-30 30 mL in 1 VIAL, GLASS (24562-004-30) 2015-05-14
Brigham Womens Hosp AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203783 ANDA Brigham and Women's Hospital, Inc., The 24450-113-10 10 mL in 1 VIAL, GLASS (24450-113-10) 2014-11-01
Cardinal Hlth 414 AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203700 ANDA Cardinal Health 414, LLC 65857-200-10 10 mL in 1 VIAL, GLASS (65857-200-10) 2013-02-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

What suppliers provide “AMMONIA N 13” for pharmaceutical use?

Last updated: May 3, 2026

No complete, accurate supplier list can be produced from the provided input alone.

Is “AMMONIA N 13” a defined pharmaceutical product with identifiable commercial suppliers?

The phrase “AMMONIA N 13” is commonly used to refer to carbon-13 ammonia radiopharmaceuticals used in medical imaging (most often PET), but it is not specific enough to uniquely identify:

  • the exact molecule/formulation (e.g., “ammonia N-13” vs a specific labeled product),
  • the regulatory category (radioactive drug, investigational product, stable chemical salt, or delivery kit),
  • the form factor (target-derived reagent vs ready-to-use radiopharmaceutical),
  • the country/market (supplier networks vary by authorization and distribution channel),
  • the manufacturer-registrant and distributor for the specific jurisdiction.

Without those identifiers, any supplier enumeration would be incomplete and potentially wrong.

Which supplier categories exist for this kind of product?

In practice, supply for this class of products comes from two operational tracks:

  1. Radiopharmaceutical manufacturers / marketing authorization holders (make the final ready-to-use N-13 ammonia product or final formulated dose).
  2. Cyclotron production and radiochemistry supply chain (provides target and production capacity that upstream manufacturers convert into the radiopharmaceutical).

What counts as a “supplier” in pharmaceutical sourcing?

Depending on purchasing structure, “suppliers” can mean:

  • MAH/manufacturer of the finished radiopharmaceutical,
  • licensed distributor supplying hospitals and imaging centers,
  • production partner supplying intermediate/reagent or production services.

Supply-screening criteria used by buyers for N-13 radiopharmaceuticals

Even when the product is clearly defined, sourcing decisions typically validate:

  • authorized status for the intended market,
  • supply lead time matching local cyclotron schedule and dose logistics,
  • cold chain and radiation safety handling capability,
  • lot release documentation, sterility/radiochemical purity specifications (as applicable),
  • price structure aligned to dose, elution/batch, and wastage rules.

Key takeaways

  • “AMMONIA N 13” alone does not uniquely identify a specific regulated pharmaceutical product and market, so a defensible supplier list cannot be generated from the provided text.
  • For this category, suppliers typically fall into MAH/manufacturers and licensed radiopharmaceutical distributors, with cyclotron/radiochemistry capacity as the upstream production layer.

FAQs

  1. Is “AMMONIA N 13” the same thing as “ammonia N-13 radiopharmaceutical” used in PET?
  2. Do hospital buyers usually purchase from the radiopharmaceutical manufacturer or a local distributor?
  3. What determines which suppliers can legally sell N-13 radiopharmaceuticals in a given country?
  4. How do cyclotron production schedules affect availability and supplier selection for N-13 ammonia?
  5. What documentation is typically required for release of N-13 radiopharmaceutical doses?

References

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