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Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. Exposure of the Solid oral dosage form /
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