Indoco Remedies received Establishment Inspection Report (EIR) for its sterile facility and solid dosage facility in Verna, Goa. The inspection was conducted from May 27 to June 4, 2019 and resulted in four observations of Form 483. This was mentioned to Bombay Stock Exchange (BSE) in a filing.
“We are happy to receive the EIR in less than two months from the date of inspection,” Indoco Remedies MD, Aditi Kare Panandikar, was quoted as saying. The site was endorsed with Voluntary Action Indicated (VAI) twice this year by the US regulating body. The inspection conducted was of the pre-approval kind for three Abbreviated New Drug Application (ANDAs) of injectable products.The company already has 33 ANDAs pending for approval; 17 fall under the category of Ophthalmics, 5 under injectable, and 11 under solid dosages from the site.
Indoco Remedies is a research-oriented pharmaceutical company with its head office in Mumbai, India. It is engaged in the manufacture and marketing of Formulations and Active Pharmaceutical Ingredients (APIs).