Strides’ Bangalore facility gets EIR from USFDA
The company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022, and a form 483 listing three…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
Establishment Inspection Report
US FDA completes inspection of Alkem’s manufacturing facility in Indore
In response to Form 483 issued by the US FDA containing one observation, the company had submitted a detailed CAPA plan to the…
Lupin receives EIR from US FDA for its injectable facility in Nagpur
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
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…
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