Stelis Biopharma’s facility receives EIR from USFDA
Establishment Inspection Report (EIR) from USFDA received for the drug-device combination to be commercialised from the company's…
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Establishment Inspection Report
Lupin’s Vizag API Facility Receives EIR from US FDA
The inspection for the API facility was conducted by the US FDA between January 13, 2020 and January 17, 2020
Biocon Biologics gets EIR from US FDA for two manufacturing facilities
The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for the company's…
Strides announces successful completion of US FDA inspection conducted at Bangalore facility
Inspection conducted in January 2020 was for specific Extended Release applications
Alkem Labs gets EIR from US FDA for Baddi facility
The Baddi facility was inspected by the US FDA from February 17 to 21, 2020 Alkem Laboratories said the US health regulator has…
Cadila Healthcare gets EIR from US FDA for its Ahmedabad facility
The facility completed the US FDA audit from December 16 to 20, 2019 with zero 483 observations, it added
Strides Pharma gets USFDA inspection report for Alathur unit with no adverse observations
The company has received the establishment inspection report (EIR), thereby confirming the successful closure of the inspections
Zydus Cadila gets EIR from US FDA for Ankleshwar facility
The EIR report stated that the classification of the facility is "No Action Indicated (NAI)", the company added
Dr Reddy’s Lab gets EIR from US FDA for Vizag units
The US FDA gives EIR on closure of inspection of an establishment that is the subject of an USFDA or US FDA-contracted inspection
Lupin gets EIR from USFDA for Aurangabad facility
The facility was inspected by the US Food and Drug Administration (US FDA) between May 6-15, 2019, Lupin said in a BSE filing