- 01 Aug 2022
- ICICIdirect Research
CASPER PHARMA COMPLETES USFDA PRE-APPROVAL INSPECTION
SUVENPHAR - 1178 Change: -30.40 (-2.52 %)News: USFDA has completed a pre-approval inspection at Suven Pharma’s subsidiary Casper Pharma, formulations manufacturing facility situated at GMR Hyderabad SEZ. USFDA audit for three product applications was completed successfully with zero observations.
Views: Suven Pharma acquired Casper Pharma recently for US$20.5 million (Rs 156 crore). Casper has a manufacturing unit dedicated to the manufacture of solid and liquid oral pharmaceuticals for US and regulated markets. It also has a seven-year contract with Rising Pharma to manufacture and supply formulations for all products developed by Rising Pharma. In filings term, Casper targets to file 15 ANDAs in FY23. Early regulatory clearance indicates to a positive note about regulatory compliance at the facility. Company is looking to expand its existing formulations footprint and even if it’s a lower margin business, better execution prowess in terms of compliance, rising pharma’s agreement and new launches can help in quick ramp-up of this business.
Impact: Neutral.