Glenmark Pharmaceuticals updated the exchanges regarding an inspection conducted by the USFDA between April 15-20, 2019, at the company’s Baddi facility in Himachal Pradesh. The company had earlier informed that the inspection was classified as an “Official Action Indicated” vide a letter by the USFDA. With regard to the same inspection, the USFDA has now issued a “Warning Letter” to the Baddi facility.
The company said that it is committed to working along with the USFDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the USFDA within 15 working days.
It stated, "We believe that the existing manufacturing and the sale of products from this facility will not be impacted. The Baddi facility is expected to contribute $30mn in total sales for this financial year which is approximately 7% of the total US sales."
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