Granules India's paracetamol facility passes USFDA check

Written By Unknown on Senin, 16 Juni 2014 | 21.04

The company's four API facilities have passed the USFDA inspections in the past 12 months, Granules India said. Hyderabad-based Granules India has facilities for APIs, pharmaceutical formulation intermediates (PFIs) and finished dosages, serving customers in over 60 countries.

Drug firm Granules India 's paracetamol manufacturing facility at Bonthapally in Andhra Pradesh has passed an inspection by the US health regulator.

The company's paracetamol facility has successfully passed a United States Food and Drug Administration (USFDA) inspection without any '483 observations', Granules India said in a filing to the BSE.

"The facility has the world's largest single active pharmaceutical ingredient (API) production line by volume," it added.

An FDA Form 483 is issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and other related acts.

The company's four API facilities have passed the USFDA inspections in the past 12 months, Granules India said. Hyderabad-based Granules India has facilities for APIs, pharmaceutical formulation intermediates (PFIs) and finished dosages, serving customers in over 60 countries.

Shares of Granules India were trading at Rs 401.75 per scrip in the afternoon trade today, up 1.40 per cent from its previous close, on the BSE .

Granules India stock price

On June 16, 2014, Granules India closed at Rs 407.40, up Rs 11.20, or 2.83 percent. The 52-week high of the share was Rs 429.00 and the 52-week low was Rs 103.70.


The company's trailing 12-month (TTM) EPS was at Rs 39.78 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 10.24. The latest book value of the company is Rs 132.94 per share. At current value, the price-to-book value of the company is 3.06.


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