News about "Establishment Inspection Report (EIR) "

Aurobindo Pharma's Raleigh Plant Receives VAI Classification from US FDA

Aurobindo Pharma’s Raleigh plant receives Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (FDA), closing the inspection and allowing pending inhaler and dosage-form applications to progress.

Establishment Inspection Report (EIR) | 17/08/2026 | By News Bureau

Cipla's InvaGen Receives US FDA EIR for New York Manufacturing Facility

Cipla's subsidiary InvaGen has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), marking the successful closure of the inspection at its New York facility.

Establishment Inspection Report (EIR) | 04/08/2026 | By News Bureau |  105

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 |  186

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 |  212

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 |  306

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 |  253

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 |  352

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 |  769

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 |  778

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 |  463