Therapeutical category

Cholesterol lowering agent

Characteristics

A crystalline powder

Applications

A crystalline powder suitable for the manufacture of drug products after the addition of appropriate excipients. The particle size of the product is designed for optimal performance.

Regulatory information

EU: CEP 2010-366, Written Confirmation (WC)

US: DMF (no. 29520)

Canada: DMF (MF 2016- 114)

Russia: MoH

Ukraine: MoH

Belarus: MoH

India: MoH

Bangladesh: MoH

China: IDL (SFDA)

Taiwan: TFDA (MF20(1830)

Korea: MFDS