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News: Zydus has received a Warning Letter issued by the USFDA relating to its Injectables manufacturing facility at Jarod near Vadodara.The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations and does not contain any data integrity related violations.
Views: Zydus overall has 66 pending ANDA’s and 21 tentative approvals, Out of these pending approvals 10 ANDA’s are related to injectable products and Jarod facility has filed for 5 injectable ANDA’s.These filings are not critical in nature in terms of growth perspective.The facility contributes around 3-4% of overall US sales however warning Letter resolution could lead to remediation costs and hence some dent on margins are expected.
Impact: Neutral