Natco Pharma is up amongst the top five gainers on the BSE since opening bell. From Friday’s close of Rs.797.65, it went up to Rs.849. Its 52-week high is at Rs.1080.
There was good news. The company announced on Saturday that the US FDA completed a successful regulatory inspection of its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India.
This was conducted during the period 12th February, 2018 to 16th February, 2018.
The regulatory audit resulted in zero observations (no form 483 issued).
The Mekaguda facility was last inspected by the regulator in October 2014. The Establishment Inspection Report, issued after the audit, was received by the company in Jan. 2015.
The company seems to have learnt the ways and procedures of manufacturing as per the US FDA, getting its facilities FDA ready. Last month, the company got EIR from the US Food and Drug Administration (USFDA) for the inspection conducted at its drug manufacturing facility at Kothur village in Telangana. EIR is given to an establishment after completion of inspection by the USFDA.