Alembic gains EIR for its Oral Solid Formulation Facility(F-1) at Panelav
The inspection took place from July 17, 2024, to July 26, 2024
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Browsing Tag
EIR
Eugia Steriles receives EIR from US FDA
The inspection was conducted between March 28, 2024 to April 05, 2024
U.S. FDA issues EIR with VAI classification for Torrent Pharmaceuticals’ Indrad facility
Torrent Pharmaceuticals Indrad manufacturing facility receives closure notice from U.S. FDA following inspection
Dr. Reddy’s receives EIR for FTO-3 Bachupally plant
During the inspection, the facility received 10 observations
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
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)