Kindeva's $200M Sterile Injectable Investment is Raising Compliance Standards

About this episode

Tommy Shornak discusses Kindeva's $200 million investment in sterile injectables and its implications for compliance and outsourcing.

"At Kindeva, we want to be viewed as a fully Annex 1 compliant facility and partner that can pivot when needed and supply uninterrupted to the patients that need it." Tommy Shornak , Senior Vice President of Sterile Injectables at Kindeva, brings nearly 20 years of sterile manufacturing operations experience from organizations including AMRI, Thermo Fisher Scientific, and Gilead Sciences. Since joining Kindeva in 2025, Tommy has been at the center of the company's investment strategy. In the latest PharmaSource podcast, Tommy explains why Kindeva's approach to sterile injectable CDMO services, anchored by a $200 million facility investment, a no-single-source supply policy, and a shift toward flexible commercial models, is designed to position the company as a one-stop partner for drug sponsors navigating an increasingly complex outsourcing landscape. Read more.

People in this episode

Guest: Tommy Shornak

Topics covered

• sterile injectables
• CDMO services
• investment strategy
• compliance standards
• outsourcing landscape

Keywords

• Kindeva
• sterile injectables
• investment
• compliance
• CDMO

Mentioned in this episode

Organizations: Kindeva, AMRI, Thermo Fisher Scientific, Gilead Sciences

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