Granules India receives 11 observations for its Gagillapur facility

Hyderabad-headquartered, pharmaceuticals company, Granules India in an exchange filing, post market hours on Friday, January 6, 2017 has informed of receiving 11 observations from the Portuguese regulator INFARMED (InstitutoNacional da Farmcia E Do Medicamento).

The regulator had conducted a renewal inspection on the company’s facility located at Gagillapur, Telangana. With respect to the inspection being carried out, the regulator has raised 11 observations in its report.

The facility under the scanner manufacturers pharmaceuticals' formulations, intermediates and finished dosages.

The Company further stated that it has initiated necessary steps to address the observations of the inspection agency, and will submit its response with a corrective and preventive action plan within the stipulated timeframe.

Granules India's stock has recently been a rank underperformer, bogged down by regulatory woes related to its facilities. Recently in December 2016, USFDA issued seven observations on the Vizag facility, after it being investigated by the authorities.

Regulatory concerns have been a long over hang on the stock price, easing of which doesn’t look possible anytime soon.

However, Granules' stock is likely to be under the hammer, when the market opens for trading on Monday, January 9, 2017.