The United States Food and Drug Administration (USFDA) has successful concluded inspection at Indoco Remedies’ Clinical Research Organization – AnaCipher. The inspection conducted between July 11th- 15th, 2022. During the remote record review, the agency did not identify any objectionable conditions and thus, did not have any observations. This inspection was conducted by the Division of New Drug Study Integrity, Office of Study Integrity and Surveillance of USFDA. The scope of the inspection included Bioanalytical phase of multiple studies, of which one was ‘First to File’.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
