The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
DeltaV control system natively integrated into Sartorius Biostat STR bioreactors provide a foundation for semi-autonomous operations and up to 80% less integration time
With an annual revenue of about $500 million, Spectrum will become part of the Industrial Solutions line of business within the Electronics & Industrial segment
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Pratima takes on the role of Country Speaker in addition to her role as GM and MD of Merck Specialties in India
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
The judicial response to industry lawsuits on drug pricing regulations have been mixed in the past
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