Reshoring pharmaceutical manufacturing back to the US. We are in the business of manufacturing sterile injectable pharmaceuticals in the United States..
With US moving more towards make in America and the US FDA getting aggressive on non-US sites, marketers of approved generics will need to move towards making products locally in the US. There is already a massive scarcity of manufacturing capacity in the US and this reshoring will create a huge demand/supply gap.
- Fully automated facility minimized human contact for sterile drug product strict tolerances that yield consistent results
- Scalable manufacturing aqueous sterile injectable products manufactured in a single line variable batch sizes ranging from 4000 to 50,000 vials
- FDA inspected facility inspected & approved by the U.S. Food & Drug Administration & US Department of Veterans Affairs
The US is the largest pharmaceutical market in the world with more than 85% of global sales $’s being spent in the US on pharmaceuticals, yet there are less than 150 sterile injectable manufacturers in the US. The last greenfield facility came online more than 10 years ago. US consumes 8 billion units of injectables annually. Of these 5 billion units are imported. Even if 20% of this import is moved to the US, the headroom is enormous..
CO- FOUNDER & CEO: Over 25 years in the global pharmaceutical industry. Founded multiple successful Pharma companies in India and US.
DIRECTOR OF MANUFACTURING: 17 years in sterile manufacturing. Has led teams of 300+ manufacturing personnel.
VICE PRESIDENT OF QUALITY: 20+ years in Quality Assurance (QA). Extensive experience in Quality Control & QMS systems.
DIRECTOR OF ENGINEERING: Spent 8 years as an engineer in India’s leading pharmaceutical design firm. Spearheaded the setup of US FDA standard facilities.
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