Jubilant Pharmova receives VAI from USFDA for its API manufacturing facility
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
With the receipt of the EIR, the inspection stands successfully closed.
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
FDA changes inspection classification of the facility to Voluntary Action Indicated
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