Phathom Pharmaceuticals Inc's Comment on Supply Chain
The company sources raw materials and manufactures vonoprazan and related products through third-party suppliers Catalent, Evonik, and Sandoz. Catalent and Evonik produce vonoprazan drug substance and drug product, while Sandoz manufactures amoxicillin and clarithromycin and handles packaging for antibiotics and vonoprazan. All supplier facilities are FDA-approved and undergo regular inspections to maintain compliance with current Good Manufacturing Practices (cGMP) and regulatory standards. The company acknowledges a potential risk of supply disruption, particularly concerning Sandoz's supply of clarithromycin tablets used in VOQUEZNA TRIPLE PAK, although no immediate disruptions are expected. The company’s reliance on these third-party manufacturers for regulatory compliance and production presents a risk that any manufacturing or regulatory issues could adversely affect product commercialization and development.
Phathom Pharmaceuticals Inc's Comment on Supply Chain
The company sources raw materials and manufactures vonoprazan and related products through third-party suppliers Catalent, Evonik, and Sandoz. Catalent and Evonik produce vonoprazan drug substance and drug product, while Sandoz manufactures amoxicillin and clarithromycin and handles packaging for antibiotics and vonoprazan. All supplier facilities are FDA-approved and undergo regular inspections to maintain compliance with current Good Manufacturing Practices (cGMP) and regulatory standards. The company acknowledges a potential risk of supply disruption, particularly concerning Sandoz's supply of clarithromycin tablets used in VOQUEZNA TRIPLE PAK, although no immediate disruptions are expected. The company’s reliance on these third-party manufacturers for regulatory compliance and production presents a risk that any manufacturing or regulatory issues could adversely affect product commercialization and development.
Sources:
Phathom Pharmaceuticals Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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