The US Food and Drug Administration (FDA) has classified the inspection conducted at pharmaceutical company Lupin Ltd’s Tarapur manufacturing facility as official action indicated (OAI). The US regulator, which conducted the inspection from 16-20 September 2019, has concluded with three observations.
OAI means that the US FDA will recommend regulatory and administrative actions. The observations made by the US FDA and the actions against the observations have not been specified by Lupin.
In a filing with stock exchanges, the pharmaceutical company said it does believe that this inspection will disrupt its supplies or have an impact on the existing revenue from operations of this unit.
“The company is in the process of sending further updates of its corrective actions to the US FDA and is hopeful of a positive outcome," Lupin added.
Separately, Lupin said it has won Par Excellence Award at the 33rd National Convention on Quality Concept for improvement in yield and quality of Cefadroxil products.
“As a leading pharmaceutical company, we have persistently focused our efforts toward enabling manufacturing excellence at all our sites. This award endorses our approach and felicitates our efforts toward quality and continuous improvement," said Rajendra B Chunodkar, president – manufacturing operations.
Cefadroxil is used to treat certain infections of skin, throat, tonsils and urinary tract caused by bacteria.