Research & Development
Luye Pharma announces FDA pre-approval inspection with zero observation for LY03004 manufacturing facility
5 November 2019 -

CNS pharma company Luye Pharma stated on Monday that its LY03004 manufacturing facility located in Yantai, China has successfully passed the US FDA seven day Pre-Approval Inspection (PAI), with no FDA-483 Inspectional Observation.

The US FDA Establishment Inspection Report with zero observation demonstrated the company's strong commitment and extensive expertise in ensuring compliance with the highest global quality standards, including the cGMP regulations.

LY03004 is reportedly the first microsphere product independently developed by a Chinese pharmaceutical company as well as the first innovative formulation from China that has filed a New Drug Application (NDA) in the US, with wide attention from the industry.

According to the company, LY03004 is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar I disorder. LY03004 can improve medication compliance in patients, has a shorter period of oral supplementation after the first injection than the reference drug and the steady plasma drug levels of LY03004 can be achieved much faster than the reference product.

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