BRIEF-Indoco Remedies Says USFDA retains OAI status of Co's Goa Plant 1

Stock MarketsApr 24, 2019 11:30

April 24 (Reuters) - Indoco Remedies Ltd INRM.NS :


* UNITED STATES FOOD AND DRUG ADMINISTRATION (USFDA) RETAINS THE OFFICIAL ACTION INDICATED (OAI) STATUS FOR GOA PLANT- I

* FACILITY WAS INSPECTED BY THE USFDA IN JANUARY 2019

* OAI STATUS WILL NOT IMPACT CO'S CURRENT COMMERCIAL SUPPLIES TO USA OR REVENUES FROM THE MANUFACTURING FACILITY

* OAI STATUS MAY WITHHOLD APPROVAL OF CO'S PENDING ANDAS FROM FACILITY