Cipla Limited announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals, Inc., has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA). This report indicates the closure of the Pre-Approval Inspection (PAI) conducted at InvaGen’s manufacturing facility located in Hauppauge, Long Island, New York, USA. The update follows a previous intimation regarding the inspection dated February 10, 2026.
USFDA Inspection Closure for InvaGen Facility
Cipla Limited has officially updated stakeholders regarding the USFDA inspection at its subsidiary, InvaGen Pharmaceuticals, Inc. The company announced on August 4, 2026, that InvaGen has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA). This development signifies the closure of the Pre-Approval Inspection (PAI) that was conducted at InvaGen’s manufacturing facility situated in Hauppauge, Long Island, New York, USA.
Background of the Inspection
This announcement follows up on Cipla’s previous communication dated February 10, 2026, which informed the exchanges about the PAI conducted by the USFDA at the InvaGen facility. The receipt of the EIR, indicating the closure of the inspection, is a positive step for the subsidiary’s operations and regulatory standing in the United States market.
Source: BSE