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Alkem's Product Approval withhold by USFDA

Updated: 22 March 2019

A pre approval inspection was done at St. Louis manufacturing of Alkem Dated 06 February 2019. The firm has received eight Form 483 observations by USFDA. Product approval is withheld from their site until the final assessment of firm. An explanatory response has been already sent by firm with response to observations.

The said product is not currently being manufactured in firm until it gets the USFDA approval. This site is involved in the manufacturing of solids, semisolids, nasal sprays and liquids. An establishment inspection report has been received by facility in December 2018 after a regular cGMP inspection by USFDA.