Suppliers and packagers for TOBI PODHALER

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	224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 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

Suppliers for the Pharmaceutical Drug: TOBI PODHALER

Last updated: July 29, 2025

Introduction

TOBI PODHALER, a dry powder inhalation therapy containing tobramycin, is primarily prescribed for patients with cystic fibrosis (CF) to combat Pseudomonas aeruginosa infections. Developed by Novartis and marketed by Chiesi Pharmaceuticals since its approval by the FDA in 2013, TOBI PODHALER's supply chain involves multiple stakeholders across raw material procurement, manufacturing, distribution, and regulatory domains. This article explores the key suppliers involved in the production of TOBI PODHALER, their roles, and implications for stakeholders within the pharmaceutical supply ecosystem.

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Overview of TOBI PODHALER Composition

TOBI PODHALER's formulation consists of tobramycin, a potent aminoglycoside antibiotic, encapsulated within a dry powder inhaler device. The drug's manufacturing hinges on high-quality active pharmaceutical ingredient (API) supply, excipient formulation, inhaler device assembly, and packaging. Ensuring an uninterrupted supply chain is critical given the medication's life-saving role in CF management.

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Key Suppliers in the TOBI PODHALER Supply Chain

1. Tobramycin API Suppliers

The core raw material for TOBI PODHALER is tobramycin, an antibiotic predominantly sourced from specialized manufacturers capable of producing pharmaceutical-grade API in compliance with Good Manufacturing Practices (GMP). Major suppliers include:

• Firmenich: A leading global producer of pharmaceutical intermediates and APIs, Firmenich supplies tobramycin for various formulations, including inhalation products. Their manufacturing facilities adhere to strict GMP standards, delivering high-quality API necessary for inhalation drugs [1].

• Rotam Chemicals: An established producer of aminoglycoside antibiotics, Rotam supplies tobramycin globally and is recognized for its consistent quality, regulatory compliance, and capacity to meet large-volume demands [2].

• SNDA (Shandong Nakse Pharmaceutical Co., Ltd.): Based in China, SNDA is expanding its GMP-certified API manufacturing capabilities, including aminoglycosides like tobramycin, catering to both domestic and international markets [3].

2. Excipients and Additives Suppliers

The dry powder inhaler's formulation requires excipients to facilitate aerosolization and stability:

• Lipid-based carriers: Suppliers like Avanti Polar Lipids provide phospholipids used in some inhalation formulations, though TOBI PODHALER primarily relies on micronized API within cartridges.

• Disaggregants and stabilizers: Companies such as Dow Chemical or BASF supply excipients like magnesium stearate, which are critical in powder flow and dispersibility [4].

3. Device Manufacturing and Assembly Suppliers

TOBI PODHALER utilizes a proprietary dry powder inhaler device designed by Novartis, with subsequent supply and assembly managed by external contract manufacturing organizations (CMOs):

• Philips Respironics or Pari GmbH: Known for their expertise in inhaler device manufacturing, these firms produce inhalation devices and components, often under licensing agreements.

• Chiesi's Contract Manufacturing Partners: As the current marketer for TOBI PODHALER, Chiesi collaborates with specialized CMO facilities globally for device assembly, sterilization, and packaging.

4. Packaging Suppliers

High-precision blister packaging manufacturers such as Suzuki Packaging or Bemis Company (now part of Amcor) supply blister foil and sealing components that meet regulatory standards for pharmaceutical products [5].

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Regulatory and Quality Considerations

Suppliers supplying APIs and excipients for TOBI PODHALER must comply with stringent regulatory standards, chiefly the FDA's CGMP guidelines and equivalents globally. Inspections and certifications ensure APIs are free from contaminants and consistent in quality. Disruptions or regulatory non-compliance at any link pose risks to product availability and patient safety.

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Supply Chain Dynamics and Risks

The global COVID-19 pandemic, geopolitical tensions, and raw material shortages impact the supply chain for critical API and excipients. Disruptions at any supplier can lead to manufacturing delays, affecting distribution and patient access. Novartis and Chiesi have strategically diversified supplier bases to mitigate such risks.

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Emerging Trends and Supplier Strategies

• Vertical Integration: Some pharmaceutical companies are investing in in-house API production to reduce dependence on external suppliers.

• Localization and Diversification: Sourcing from multiple regions diminishes exposure to regional disruptions; for example, diversifying API sources across China and India.

• Sustainability and Regulatory Compliance: Suppliers are increasingly adopting green chemistry practices, which may influence procurement decisions.

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Conclusion

Supply of TOBI PODHALER hinges on a complex, multi-tiered network of suppliers, from high-grade tobramycin API producers to device component manufacturers. Ensuring continuity involves rigorous qualification processes, diversified sourcing strategies, and compliance with global regulatory standards. Navigating these supply chain intricacies is vital for stakeholders aiming to maintain uninterrupted patient access.

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Key Takeaways

• TOBI PODHALER's core raw material, tobramycin API, is supplied by specialized manufacturers such as Firmenich, Rotam, and SNDA, emphasizing the importance of strict quality and regulatory compliance.

• The device component supply chain involves high-precision manufacturing partnerships, underscoring the importance of collaboration with experienced inhaler device producers.

• Supply chain resilience is critical; diversification of API and excipient sources mitigates risks associated with geopolitical, logistical, or pandemic-induced disruptions.

• Regulatory adherence at each supply chain tier ensures product integrity, safety, and efficacy.

• Market dynamics favor suppliers capable of scaling production while maintaining rigorous quality standards, highlighting ongoing opportunities for new entrants with GMP-compliant manufacturing.

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FAQs

1. Who are the primary API suppliers for TOBI PODHALER?
Major API suppliers include Firmenich, Rotam Chemicals, and SNDA, all of which produce pharmaceutical-grade tobramycin in compliance with GMP standards.

2. Are there alternative suppliers for tobramycin API for TOBI PODHALER?
Yes, suppliers such as Teva Pharmaceutical Industries and other regional API manufacturers are exploring or supplying tobramycin, but selection depends on regulatory approval, quality, and capacity.

3. What role do device manufacturers play in the TOBI PODHALER supply chain?
Device manufacturers produce the inhaler components and assemble finished devices, ensuring functionality, regulatory compliance, and sterility—key for delivering the drug effectively to patients.

4. How do supply chain disruptions affect TOBI PODHALER availability?
Disruptions in API or device component supply can cause manufacturing delays, resulting in shortages and impacting patient treatment continuity.

5. Are there ongoing efforts to diversify the supply chain for TOBI PODHALER’s raw materials?
Yes, pharmaceutical companies are actively diversifying suppliers and geographically dispersing sourcing to buffer against regional risks and supply disruptions.

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References

[1] Firmenich API manufacturing documentation, 2022.
[2] Rotam Chemicals API portfolio overview, 2022.
[3] SNDA Pharmaceutical API capacity report, 2021.
[4] Excipients suppliers and specifications, BASF and Dow Chemical, 2022.
[5] Pharmaceutical packaging standards and suppliers, Amcor, 2021.