Therapeutical category

Cholesterol lowering agent

Characteristics

A hygroscopic powder

Applications

A hygroscopic powder suitable for the manufacture of drug products. The appropriate excipients need to be added. The particle size of the product is designed for optimal performance.

Regulatory information

EU: CEP 2015-090,

Written Confirmation (WC)

USA: DMF (no.31410)

Canada: DMF (MF 2015-058)

Russia: in progress

Ukraine: MoH

India: MoH

Bangladesh: MoH

Korea: in progress

China: in progress

Taiwan: TFDA (MF20(2574)