Indian pharmaceutical manufacturer, Zydus Lifesciences said on March 27 that the United States Food and Drug Administration (US FDA) has slapped the company's injectable facility in Ahmedabad with four observations.
In an exchange filing, Zydus Life said the the US FDA inspected the injectable facility from March 18th to March 27th. The inspection was at the SEZ Onco Injectable manufacturing plant, according to the statement.
The company added that there were no data integrity related observations as a result of the inspection.
"The Company will closely work with the USFDA to address the observations," it added in the press statement.
Earlier on 26 March, Zydus Life's shares surged after the company received tentative approval from the US Food and Drug Administration (FDA) for its Letermovir tablets. These tablets are crucial in preventing diseases among patients undergoing bone marrow or kidney transplants.
On 27 March, the shares closed 1.82 percent down at Rs 999 on BSE.
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