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U.S. FDA Completes Inspection Of Cipla’s API Manufacturing Unit

The inspection of Cipla’s API manufacturing facility was carried out between Jan. 20 and Jan. 24.

A file photo of a Cipla factory.  (Photographer: Santosh Verma/Bloomberg)
A file photo of a Cipla factory. (Photographer: Santosh Verma/Bloomberg)

Pharmaceutical firm Cipla Ltd. on Friday said the US Food and Drug Administration has completed inspection of its Bengaluru-based manufacturing unit with four observations.

The company said it is committed to addressing these observations and will submit its response to the U.S. FDA within the stipulated time.

The inspection of Cipla's API manufacturing facility was carried out between Jan. 20 and Jan. 24.

“The United States Food and Drug Administration conducted a cGMP inspection at our API manufacturing facility in Bommasandra, Bangalore, from Jan. 20, 2020, to Jan. 24, 2020. The inspection ended with four observations which were procedural in nature and none of which were repeat or related to data integrity,” Cipla said in a stock exchange filing.

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