Indoco Remedies Limited has announced the receipt of Establishment Inspection Report (EIR), from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa for the inspection carried out between 7th October to 15th October, 2019. This was a Pre-Approval Inspection for a sterile injectable product, with two observations on Form 483s, which is now concluded as closed. The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd., commented on the receipt of the EIR, “We have received the EIR in just over a month’s time from the date of inspection. Excelling at Quality and Compliance is one of our top priorities, as we remain committed to meeting and exceeding standards set by the regulatory agencies globally.” She also added, “This second successful PAI (Pre-Approval Inspection) at the site in less than 6 months indicates steady progress in review of Indoco’s pending ANDAs. The Company has 39 ANDAs, pending for approval from this site.”
Indoco Remedies Ltd. is a $140 million company headquartered in Mumbai. It develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. The company is a fully integrated, research-oriented pharma company with a presence in 55 countries. The company employs over 6000 people, including more than 300 skilled scientists.
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