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Suppliers and packagers for TOBI PODHALER
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TOBI PODHALER
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 PODHALER | tobramycin | POWDER;INHALATION | 201688 | NDA | Viatris Specialty LLC | 49502-401-09 | 8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09) | 2021-09-01 |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688 | NDA | Viatris Specialty LLC | 49502-401-24 | 4 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 7 BLISTER PACK in 1 PACKAGE / 8 CAPSULE in 1 BLISTER PACK | 2021-09-01 |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688 | NDA | Viatris Specialty LLC | 49502-401-57 | 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACK | 2021-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TOBI PODHALER
TOBI Podhaler Suppliers (tobramycin inhalation powder) Manufacturing, CDMO Options, and Contract Source Map
TOBI Podhaler (tobramycin inhalation powder) is supplied through a constrained, vertically integrated supply chain in the U.S., with drug substance and product manufactured by specific validated sites supporting FDA commercial supply. Public procurement-level “supplier lists” are not fully disclosed in FDA and Orange Book records; however, the core supplier map for TOBI Podhaler in practice is: (1) the NDA holder supply structure, (2) the labeled manufacturing sites for the finished drug product, and (3) the labeled manufacturer of active ingredient (tobramycin) used to produce inhalation powder formulations.
The actionable supplier screen for decision-making is the set of FDA-labeled manufacturing facilities for TOBI Podhaler drug product and (when disclosed) drug substance, supplemented by known inhalation-powder CDMO capabilities (particle engineering, dry powder filling, metering device integration, and moisture-protected packaging).
Who manufactures TOBI Podhaler drug product and where?
Answer: Use the FDA labeling “Manufactured for” / “Manufactured by” disclosures and the NDA manufacturing site entries reflected in FDA databases and the product label. Those entries are the authoritative “supplier” list for regulatory and quality purposes.
What to extract from the label / FDA listing
For TOBI Podhaler, the supplier-identification fields typically include:
- Finished drug product manufacturer name and address
- Labeler (if different from manufacturer)
- Packaging site (where shown)
- Any regional distribution labeler
Supplier decision impact
- Sourcing the product from the wrong site can create batch comparability issues even if the label strength matches.
- For inhalation powders, device compatibility and packaging moisture barrier performance are part of the quality system.
How many labeled manufacturing sites supply TOBI Podhaler in the US?
Answer: The number of sites is defined by the FDA-labeled commercial supply entries for the NDA.
Why the count matters
- A single-site supply raises continuity risk.
- Multi-site supply supports surge capacity, enables temporary GMP transfer, and can reduce stock-outs.
Who supplies the tobramycin active ingredient for TOBI Podhaler?
Answer: TOBI Podhaler’s drug substance supplier is the entity manufacturing the labeled tobramycin used for the finished powder. Drug substance suppliers are often not fully enumerated publicly, but the NDA and product quality dossier identify them as the “manufactured by” or “prepared by” parties.
Supplier map categories
- Tobramycin API manufacturer (drug substance)
- Intermediate / fermentation / purification suppliers (sometimes not named publicly)
- DP powder formulation and blending site
- Dry powder filling and device-pack integration site
Which companies are most likely the CDMO/CMO suppliers for inhalation powder filling?
Answer: For a dry powder inhalation system like TOBI Podhaler, the contract manufacturing pattern typically matches CDMOs with:
- Dry powder blending and milling control
- Flow and particle-size characterization
- Dose uniformity validation under device metering
- Moisture-barrier packaging
What companies in the CDMO market match TOBI Podhaler’s needs
Global inhalation-powder and device-integrated manufacturing capabilities usually reside with:
- Particle engineering and capsule/DRI fill providers
- Device-compatible metering and packaging specialists
Procurement screening criteria
- Experience with antibiotic inhalation powders
- GMP experience with dose uniformity and aerodynamic performance
- Moisture control and stability program depth
- Proven regulatory inspection history for inhalation powders
What patents protect TOBI Podhaler suppliers and manufacturing methods?
Answer: Patent protection does not usually “name” a supplier, but it limits:
- Manufacturing methods (process patents)
- Formulation composition/powder engineering
- Device or capsule filling method
- Use claims (CF bronchiectasis, cystic fibrosis subsets, etc.)
Supplier implication
Even if a CDMO can manufacture, they may still need:
- Freedom-to-operate for formulation/manufacturing/process claims
- License access for know-how tied to device metering and stability
- Regulatory comparability commitments if manufacturing changes
What is the FDA Orange Book status of TOBI Podhaler and how does it affect suppliers?
Answer: Orange Book listings determine whether an abbreviated pathway is available and whether suppliers manufacturing “generic-equivalent” versions face IP barriers.
Commercial supply relevance
- If patents remain listed and enforceable, supplier diversification for “near-equivalent” products is slower.
- If ANDA opportunities open, new entrants may bid for manufacturing and device supply after regulatory and IP clearance.
What generic or biosimilar risk exists that could change TOBI Podhaler’s supplier landscape?
Answer: For small-molecule inhaled antibiotics like tobramycin, risk is mainly via generic inhalation powder ANDAs and any associated Paragraph IV challenges, not biosimilarity.
Supplier landscape impact
- Generic approvals can open CDMO capacity competition
- Device and capsule supply can shift to new vendors if authorized
- Price pressure typically increases, which can drive broader supplier selection
How do device and packaging requirements affect supplier eligibility for TOBI Podhaler?
Answer: TOBI Podhaler’s value chain includes:
- Dry powder formulation
- Dose metering through the inhaler device
- Capsule/blister packaging (as applicable)
- Moisture barrier requirements and stability
Typical supplier-gating criteria
- Facility validated for inhalation powder handling and cross-contamination control
- Packaging line qualified for moisture barrier performance
- Lot release testing for dose uniformity and performance
What does a practical procurement supplier diligence checklist look like for TOBI Podhaler?
Answer: A procurement-grade supplier checklist should test for regulatory, technical, and IP compliance.
Regulatory and quality
- GMP compliance history for inhalation powders
- CoA and batch release testing consistency
- Stability program results aligned to label shelf-life
Technical
- Powder particle size distribution control and lot-to-lot uniformity
- Moisture sensitivity controls and packaging barrier verification
- Compatibility with the inhaler device metering performance
IP and governance
- Freedom-to-operate assessment for any alternative manufacturing route
- License status if any process/know-how is tied to formulation patents
Who are the key commercial brand stakeholders (NDA holder and labeler) that define “supplier” access?
Answer: Supplier access is constrained by the NDA holder’s approved manufacturing and labeling model.
Decision impact
If a party is not on the NDA manufacturing/labeler approvals, onboarding is a change-control and regulatory process. Procurement should map:
- NDA holder relationships
- Authorized manufacturing sites
- Authorized packaging/distribution entities
Key Takeaways
- “Suppliers” for TOBI Podhaler should be defined by FDA-labeled manufacturing sites for finished drug product and any disclosed drug substance manufacturing identifiers.
- For inhalation powders, supplier eligibility depends on particle and dose uniformity controls, device compatibility, and moisture-barrier packaging qualification, not just API availability.
- IP status via the Orange Book and related patents affects whether new manufacturing entrants can credibly scale supply.
- Procurement diligence should combine FDA site authorization, GMP inspection history, performance testing capability, and IP freedom-to-operate for process and formulation changes.
FAQs
1) What information on TOBI Podhaler best identifies the actual manufacturing supplier?
The product label’s “manufactured by/manufactured for” statements and the FDA-registered manufacturing sites for the NDA.
2) Do TOBI Podhaler suppliers include device manufacturers?
Device components can be sourced separately, but eligibility is governed by the approved combination of device plus product as used in clinical and labeled use.
3) How can stock-out risk be assessed for TOBI Podhaler?
By the number of FDA-labeled commercial manufacturing/packaging sites and their GMP flexibility for surge supply.
4) Can third-party CDMOs manufacture TOBI Podhaler inhalation powder?
Only if they can meet validated inhalation powder and device-compatible filling requirements and clear any applicable formulation/process IP constraints.
5) Does the supplier list change when manufacturing is transferred?
Yes. Manufacturing transfers typically trigger FDA supplements and require updated FDA-labeled site entries before commercial use.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. (n.d.). Drug Approval Reports and Labeling for TOBI Podhaler. FDA.
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