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The US Food and Drug Administration (USFDA) started inspection at Indoco’s Goa Plant I (Oral Dosages Facility) on 17th January, 2019 and concluded on 25th January, 2019. The regulatory body issued 6 observations (483s) to the site. The company made the announcement via an exchange filing on Monday morning. Yet, shares of the company gained ~1% in intraday trade today.
"None of these observations are critical in nature. Indoco will respond to these observations within the stipulated time of 15 days," mentioned the company in the exchange filing.
Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited commented, “Most of these observations are related to areas of improvement needed in documentation and review procedures. These observations / recommendations will help us further improve our quality systems in the plant, which in turn, will give a boost to revenues from the US market."
The site will continue to supply to the US market the existing approved products and await approval of pending ANDAs.
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma company with presence in 55 countries. Indoco, a $161mn company, employs over 5500 people including more than 300 skilled scientists.
The Company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.
Indoco Remedies Ltd is currently trading at Rs184.40 up by Rs2.4 or 1.32% from its previous closing of Rs182 on the BSE.
The scrip opened at Rs188.45 and has touched a high and low of Rs210.40 and Rs177.55 respectively. So far 1,64,332 (NSE+BSE) shares were traded on the counter.
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