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Results For "EIR"

3316 News Found

Eugia SEZ’s injectable facility gets EIR from USFDA
Drug Approval | June 28, 2024

Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated


Lupin receives EIR from US FDA for its Somerset manufacturing facility
Drug Approval | June 25, 2024

Lupin receives EIR from US FDA for its Somerset manufacturing facility

The facility was inspected from May 7 to May 17, 2024


Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
Drug Approval | May 07, 2024

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility

With this, for all our USFDA facilities, EIRs are in place


Twinkle Khanna urges Indian women to check their iron levels
Healthcare | February 27, 2024

Twinkle Khanna urges Indian women to check their iron levels

‘Unmask Anemia’ aims to simplify assessment of iron deficiency anemia risk with an easy online self-test based on common signs and symptoms


Indoco Remedies receives EIR from USFDA for Goa Plant-I
Drug Approval | January 18, 2024

Indoco Remedies receives EIR from USFDA for Goa Plant-I

The PAI was conducted for two drug product applications (ANDAs) filed from this facility


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Bajaj Healthcare announces receipt of EIR from USFDA
Drug Approval | September 14, 2023

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations


Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
News | September 14, 2023

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated