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News about "Establishment Inspection Report (EIR) "
Lupin Receives US FDA EIR for Ankleshwar Manufacturing Facility
Lupin has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Ankleshwar facility following the successful closure of a product-specific pre-approval inspection conducted in March 2026.
Establishment Inspection Report (EIR) | 28/05/2026 | By News Bureau
Piramal Pharma Closes US FDA Inspection at Telangana Manufacturing Facility
Piramal Pharma has announced the successful closure of a US FDA inspection at its manufacturing facility in Digwal, Telangana, after receiving the Establishment Inspection Report (EIR) from the regulator, confirming the completion of the inspection process.
Establishment Inspection Report (EIR) | 18/05/2026 | By News Bureau
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 | 247
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 | 205
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 | 318
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 | 643
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 | 600
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 | 365
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