Warmly celebrate LP Pharma's new drug's US marketing authorization!

On July 22, LP Pharma's new drug Aripiprazole Orally Disintegrating Film (trade name: OPIPZA) obtained US FDA marketing authorization. The specifications approved for marketing this time are 2mg, 5mg, and 10mg, which are used to treat schizophrenia. OPIPZA is China's first oral film product approved for marketing in the United States. This is an important milestone in the globalization of LP Pharma's oral film technology platform and an important step for China's innovative preparations to go global.

The FDA approval of OPIPZA (Aripiprazole Orally Disintegrating Film) indicates that LP Pharma's film product research and development, clinical GCP, and production GMP have all reached international standards. In March this year, Aripiprazole Orally Disintegrating Film successfully passed the FDA clinical inspection with zero defects. In April, the product successfully passed the FDA's pre-market inspection (PAI).

Aligned Machinery is honored to provide LP Pharma with an oral thin film production line, which is the only oral thin film production line in China certified by the US FDA. This advanced production line is critical to ensuring OPIPZA meets the highest quality standards required for international approval.

This achievement is not only a win for LP Pharma, but also a testament to the strength of our partnership. At Aligned Machinery, we are committed to supporting our partners with the best technology and services to help them achieve their goals. We look forward to continuing to work with LP Pharma and contributing to more groundbreaking successes in the future.

Congratulations again to LP Pharma on this momentous achievement! We are excited for the future and many more milestones to come.