After opening the day on a cautious note, share markets in India have continued to remain range bound and are trading marginally below the dotted line. Sectoral indices are trading on a mixed note with stocks in the consumer durables sector and stocks in the realty sector leading the gains, while stocks in the IT sector are trading in red.
The BSE Sensex is trading down by 15 points (down 0.1%), and the NSE Nifty is trading up by 2 points (up 0.02%). Meanwhile, the BSE Mid Cap index is trading up by 0.9%, while the BSE Small Cap index is trading up by 0.6%. The rupee is trading at 65.52 to the US$.
Glenmark Pharma’s share price was in focus today as the drug major announced its Ankleshwar plant received US Food and Drug Administration (USFDA) clearance.
Glenmark Pharmaceuticals Ltd’s active pharmaceutical ingredients (API) manufacturing plant at Ankleshwar in Gujarat, in which the USFDA had earlier observed certain violations of norms, has now been cleared by the US drug regulator.
The facility received an Establishment Inspection Report (EIR) on Tuesday. The EIR is issued by the USFDA only if it finds the facility to be deemed acceptable.
Glenmark sources APIs from Ankleshwar unit for many of its crucial formulations that are supplied to the US market and, therefore, the clearance for this plant is a positive development.
The USFDA had issued a Form 483 to Glenmark’s Ankleshwar plant with four observations relating to violation of good manufacturing practices after the inspection of the facility in December 2016.
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 does not meet the USFDA’s expectations, a warning letter may be issued.
