Last Updated: June 4, 2026

Suppliers and packagers for TOBI


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TOBI

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Viatris TOBI tobramycin SOLUTION;INHALATION 050753 NDA Viatris Specialty LLC 49502-345-73 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE 2022-06-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for TOBI

Last updated: April 25, 2026

Who Supplies “Tobi” (Tobramycin) and What Is Under Contract?

“Tobi” is a brand of tobramycin used for cystic fibrosis (CF) and related bacterial lung infections. The supplier landscape depends on the specific “Tobi” product form (most commonly nebulized solution and inhalation pod/solution formats). Without the exact product version (strength, presentation, and market), supplier identification cannot be stated accurately.

What “Tobi” Product Form Are We Pricing?

“Tobi” is sold in multiple presentations in different jurisdictions. Supplier attribution requires matching:

  • Active ingredient: tobramycin
  • Dosage form: inhaled/nebulized tobramycin
  • Presentation: vial/ampoule vs pod/carton format
  • Strength: tobramycin concentration varies by product line and market

Who Are the Manufacturing and Marketing Parties?

Supplier structure for branded inhaled tobramycin typically separates into:

  • Marketing authorization holder / label owner (entity responsible for regulatory submissions)
  • Finished dosage manufacturing (where the drug product is filled/finished)
  • Active pharmaceutical ingredient (API) manufacturing (upstream supplier of tobramycin)

For “Tobi,” the most defensible supplier assignments must be taken from:

  • the local Summary of Product Characteristics / Prescribing Information
  • the approved packaging labels (PL/SmPC section for “Manufactured by” / “Distributed by”)
  • the regulatory product dossier listings for the specific country and presentation

What Do Regulatory Labels Typically Reveal?

When labels are complete, they usually list:

  • “Manufactured by” (drug product manufacturer)
  • “Distributed by” (local marketing distribution)
  • “Marketing authorization holder” (name/address)
  • Sometimes “Packaged by” vs “Manufactured by”

These fields are the basis for a contract-grade supplier list.

How Supplier Mapping Should Be Done for “Tobi”

A complete supplier map must be built as a matrix by:

  • Country (label owner and distributor change)
  • Presentation (vial versus pod)
  • Strength (different line items can have different manufacturing sites)
  • Regulatory status (originator vs authorized generic in some markets)

Key Takeaways

  • “Tobi” supplier identification cannot be stated precisely without the exact Tobi presentation and market labeling.
  • Supplier attribution must be taken from approved label/regulatory texts that name the marketing authorization holder, finished dosage manufacturer, and distributor.
  • A contract-grade answer requires a country-by-presentation mapping to avoid mixing supplier data across product lines.

FAQs

1) Is “Tobi” always the same manufacturer?
No. Supplier assignments can vary by presentation, strength, and country.

2) What roles count as “suppliers” for a branded drug like “Tobi”?
The label and dossier commonly distinguish marketing authorization holder, finished dosage manufacturer, and API source (when stated).

3) Does “Tobi” refer to tobramycin only, or also other drugs?
“Tobi” is a brand name for tobramycin in an inhaled/nebulized format used in CF.

4) Where can supplier names be verified for “Tobi”?
Through the local SmPC/Prescribing Information and packaging label sections that list manufacturer and marketing authorization details.

5) Can I use patent documents to identify suppliers?
Patents may identify some manufacturing or development entities, but regulatory labels/dossiers are what reliably confirm current manufacturing and distribution parties.

References (APA)

No sources were provided in the prompt, and no reliable, label-specific supplier data can be cited without the exact “Tobi” product presentation and jurisdiction.

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