Hikal gets Brazilian GMP certification and US FDA EIR for Bangalore and Panoli facilities
Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani) and a…
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Browsing Tag
Establishment Inspection Report
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
Indoco receives EIR for its manufacturing facility in Goa (Plant I)
The receipt of the EIR with VAI status also signifies the imminent closeout of the Warning Letter issued by the USFDA in July 2019…
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…
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