Lupin receives EIR from U.S. FDA for Aurangabad facility
The Establishment Inspection Report follows a product-specific Pre-Approval Inspection conducted by the U.S. FDA at Lupin’s…
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Establishment Inspection Report
Alembic Pharma gets EIR for its API – I & API – II facility located at Panelav
USFDA had carried out the inspection between May 26 – May 31, 2025
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
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…