After opening the day flat, Indian share markets have gone on to trade marginally below the dotted line. Sectoral indices are trading on a mixed note with stocks in the realty sector and oil & gas sector witnessing maximum buying interest. Auto stocks are trading in the red.

The BSE Sensex is trading down 116 points (down 0.4%) and the NSE Nifty is trading down by 32 points (down 0.4%). Meanwhile, the BSE Mid Cap index is trading down by 0.3%, while the BSE Small Cap index is trading flat. The rupee is trading at 66.83 to the US$.

In news from stocks in the pharma sector, Cadila Healthcare share price announced that the company received three observations from The US Food and Drug Administration (USFDA) for its formulation facility at Baddi, Himachal Pradesh.

The drug major further clarified that the observations were related to a pre-approval inspection (PAI) for a specific product filed. The product in question is yet to be manufactured or marketed in the US.

USFDA inspected the facility from 20 February to 1 March, 2017 and issued a Form 483 with five observations.

Form 483 relates to certain critical observations issued to a company at the end of an inspection if there were any violations of the Food Drug and Cosmetic Act and other related acts of the US Government.

Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the USFDA’s expectations, a warning letter may be issued.

Cadila said it is already in the process of responding to the PAI observations.

The company clarified that apart from product related observations, there were no observations related to current good manufacturing practices.

Cadila recently cleared a USFDA re-audit for its Moraiya plant in Gujarat without observations indicating a successful resolution of the warning letter.