Everest Organics Ltd updates on USFDA inspection

Everest Organics Limited ("Company") went through a USFDA (US Food and Drug Administration) CGMP (Current Good Manufacturing Practice) inspection of its factory located at 38, Aroor Village, Sadasivpet Mandal, Sangareddy District - 502291.

Our Company is a manufacturer of active pharmaceutical ingredients (API) for the global pharmaceutical industries, which includes the U.S. commercial pharmaceutical market. The firm's APIs are used to manufacture finished products for compounding pharmacies and ANDA (Abbreviated New Drug Application) generic drugs, which can be distributed in the United States (U.S.) as well.

The firm's drug master files are filed as part of ANDAs with firms that are registered with the USFDA as a drug manufacturer or an applicant, for the commercialization of the finished products to the US market.

The current inspection provided CGMP surveillance coverage of the firms Quality, Production, Facilities & Equipment and Laboratory Control systems. At the conclusion of the inspection, no FDA 483, Inspectional Observations, was issued.

The firm's drug registration with the USFDA is current as of this inspection.

Shares of EVEREST ORGANICS LTD. was last trading in BSE at Rs. 125.55 as compared to the previous close of Rs. 124.25. The total number of shares traded during the day was 3691 in over 45 trades.

The stock hit an intraday high of Rs. 127.10 and intraday low of 122.80. The net turnover during the day was Rs. 462957.00.

Source : Equity Bulls

Keywords

EVERESTORGANICS INE334C01029 USFDA CGMPInspection