Sudhir Ghule

Vice President and Head of Technical Operations USA Cluster

Responsible for technical operations at Kurkumbh and Satara Locations. Was responsible for multiple brown field projects for various capacity expansion projects. Have successfully handled 3 USFDA inspections. Have successfully launched many new products to US and to other regulated countries. Have assisted Cipla US site for the start up operation of newly acquired facility. Have filed many ANDA from the Kurkumbh site. Have initiated the digitization, simplification and automation drive to develop a robust product process. Key result areas include maintaining high standards of EHS and Quality; Supply Security for all customer and countries from the location, support Product Filings and New Product Launches; continuous focus on Cost / Manpower Productivity; attracting & retaining Key Talent.

Was involved in the erection and commissioning of the green field project from the conceptual stage and taken it forward to completion followed by managing the technical operations. Have installed the first facility of Lupin for manufacturing of Inhalers including MDIs and DPIs. During the tenure have filed two ANDA from this site. Handled the brown field project of capacity expansion in warehouse and additional area for the manufacturing of pellets as dry syrup in bottle pack.

Was responsible for taking up the start up operation of the newly created facility for OSD manufacturing.

Was responsible for managing the technical operations of the sterile LVP and OSD (Tablets and Capsules) facility. Have successfully handled the MCC (South African) inspection.