Cipla's InvaGen Receives USFDA EIR for New York Manufacturing Facility
Mumbai: Cipla Limited has 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), marking the closure of the inspection conducted at its manufacturing facility in Hauppauge, Long Island, New York, USA.
The company disclosed the development through a regulatory filing made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The update follows Cipla's earlier communication dated February 10, 2026, regarding the Pre-Approval Inspection (PAI) carried out by the USFDA at the manufacturing facility of InvaGen Pharmaceuticals.
According to the company, the USFDA has now issued the Establishment Inspection Report (EIR), indicating that the inspection has been officially concluded. Receipt of an EIR signifies the formal closure of the inspection process by the US regulatory authority.
The inspection had been conducted at InvaGen Pharmaceuticals, Inc., a wholly owned subsidiary of Cipla Limited, at its manufacturing facility located in Hauppauge, Long Island, New York.
According to Cipla Limited, InvaGen's receipt of the Establishment Inspection Report confirms the closure of the USFDA inspection at the New York manufacturing facility.
