A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
The facility has been classified as Voluntary Action Indicated
The inspection concluded with NIL observations
The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Eugia Pharma Specialities restarts production at terminally sterilized product lines
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
The company will address the observations within a stipulated timeline working with the regulators
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As of June 30, 2021, 267 out of a total of 427 SEZs approved by the government are operational
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