The US Food and Drug Administration (USFDA) completed a pre-approval inspection at Casper Pharma formulations manufacturing facility situated at GMR Hyderabad SEZ.
Casper Pharma is a wholly-owned subsidiary of Suven Pharmaceuticals, Hyderabad, India.The inspection was conducted from 25 July through 29 July 2022. The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
"We are glad to have completed the audit successfully with Zero observations and at the end of the inspection no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations," Venkat Jasti, managing director of Suven Pharmaceuticals said in a statement.
In April 2022, the board of Suven Pharma approved acquisition of Hyderabad-based Casper Pharmaceuticals for Rs 155 crore. Casper is engaged in formulations business.
Hyderabad-based Suven Pharmaceuticals is a pure-play contract development and manufacturing company (CDMO) player. Its services include custom synthesis, process R&D, scale-up and contract manufacturing of intermediates, APIs and formulations.
On a consolidated basis, net profit of Suven Pharmaceuticals rose 10.29% to Rs 91.67 crore on 40.40% rise in net sales to Rs 363.85 crore in Q4 March 2022 over Q4 March 2021.
Shares of Suven Pharma rose 2.21% to Rs 481.15 on Friday, 29 July 2022.
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