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
FDA has concluded that this inspection is 'closed'
Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
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