Lupin gets EIR from US FDA for Pithampur Unit-2 facility
The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023
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Browsing Tag
EIR
Alembic Pharma gets EIR from USFDA for its solid oral formulation facility at Jarod
This was pre-approval inspection to cover Alembic’s solid oral drug products for which ANDAs were filed with USFDA
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…
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…
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 Goa manufacturing plant gets EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated (VAI)
Biocon receives EIR for its Bommansandra facility
The inspection was carried out from January 20-24, 2020
Dr Reddy’s gets EIR from USFDA for Srikakulam plant
All facilities under warning letter are now determined as ‘voluntary action indicated’
Natco Pharma gets EIR from USFDA for Telangana facility
USFDA had conducted pre-approval inspection at Natco’s facility in Kothur village from March 2-6, 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…