USFDA issues 2 observations for Cipla arm Mahape facility

On conclusion of the inspection, Sitec received 2 (two) observations in Form 483. 

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"The Company will work closely with the USFDA and remains committed to address these observations comprehensively within stipulated time," Cipla stated in a BSE filing.

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In addition to the inspection at the Company's arm, Cipla has also received final approval from the USFDA for the New Drug Application (‘NDA’) submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’. Nilotinib is an oncology category product in capsule form for oral consumption and is used for treatment of philadelphia chromosome positive chronic myeloid leukemia.

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