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News about "Establishment Inspection Report (EIR) "
Glenmark Pharmaceuticals Receives EIR from US FDA for Monroe Facility
Glenmark Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US FDA for its formulations manufacturing facility in Monroe, with a Voluntary Action Indicated (VAI) status.
Establishment Inspection Report (EIR) | 27/11/2025 | By Dineshwori | 116
Lupin Receives EIR from US FDA for its Aurangabad (CSN) Facility
Lupin has received an Establishment Inspection Report (EIR) from the US FDA for its Aurangabad (CSN) facility, marking the successful closure of a product-specific Pre-Approval Inspection conducted between September 1 and September 5, 2025.
Establishment Inspection Report (EIR) | 14/11/2025 | By Dineshwori
Lupin Receives EIR from US FDA for its Pithampur Unit-3 Facility
Following an inspection in July 2025, Lupin received the USFDA’s Establishment Inspection Report (EIR) for its Pithampur Unit-3 facility.
Establishment Inspection Report (EIR) | 06/11/2025 | By Dineshwori | 176
NATCO Pharma's Kothur Facility Receives FDA EIR with VAI Classification
The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.
Establishment Inspection Report (EIR) | 18/09/2025 | By Dineshwori | 402
Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities
Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.
Establishment Inspection Report (EIR) | 15/09/2025 | By Dineshwori | 302
Unichem Receives EIR with VAI Status from USFDA for Roha API Facility
Unichem Laboratories has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Roha active pharmaceutical ingredients (API) facility.
Establishment Inspection Report (EIR) | 27/08/2025 | By Dineshwori | 213
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