The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
The facility was inspected from May 7 to May 17, 2024
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