Strides Alathur receives EIR from USFDA for its Chennai facility
The facility manufactures tablets and capsules and supports several current and future products for the US markets
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Establishment Inspection Report
Lupin receives EIR from U.S. FDA for its Dabhasa facility
The facility receives U.S. FDA 'No Action Indicated' status
US FDA completes inspection at Alkem’s Baddi facility
The Inspection was classified as Voluntary Action Indicated (VAI)
Lupin gains EIR from US FDA for its Somerset manufacturing facility
The facility was inspected from May 7 to May 17, 2024
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…
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