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

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

Cipla has announced that its wholly owned subsidiary, InvaGen Pharmaceuticals Inc., has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its manufacturing facility in Hauppauge, Long Island, New York, indicating the successful closure of the regulatory inspection.

The update follows the company's earlier disclosure regarding the Pre-Approval Inspection (PAI) conducted by the FDA at the facility in February 2026. According to Cipla, the issuance of the EIR confirms the conclusion of the inspection process by the US regulator.

The company disclosed the development in a regulatory filing submitted to the Bombay Stock Exchange (BSE), the National Stock Exchange of India (NSE) and the Luxembourg Stock Exchange in compliance with the Securities and Exchange Board of India’s (SEBI) Listing Obligations and Disclosure Requirements (LODR) Regulations.

More news about: quality / gmp | Published by News Bureau | August - 04 - 2026

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