Natco Pharma's Telangana facility faces 6 observations from US drug regulator

In August last year, Natco had received Establishment Inspection Report (EIR) for the same facility from the US health regulator after successful completion of inspection

|Jan 25, 2017, 12:59:21 IST

New Delhi: Natco Pharma Wednesday said the US health regulator has made six observations after the completion of inspection of its Kothur formulation facility in Telangana.The United States Food and Drug Administration (USFDA) had inspected the Kothur formulation facility between 16-24 January, 2017, Natco Pharma said in a BSE filing.The company, however, added that all observations are correctable and procedural and it believes are minor in nature.[caption id="attachment_298621" align="alignleft" width="380"] Reuters[/caption]"The observations are related to complaint and incident investigations, stability backlog and procedural SOPs," it said.Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observations.In August last year, the drug firm had received Establishment Inspection Report (EIR) for the same facility from the US health regulator after successful completion of inspection.EIR is given to an establishment after the completion of the inspection by the USFDA.Shares of the company were trading 0.49 per cent higher at Rs 641.75 apiece on BSE.

Can a record May offset a shrunk international schedule and help IndiGo turn a profit?

Record domestic market share boosts operating performance, but forex losses, rising oil prices and geopolitical disruptions could weigh on IndiGo's bottom line.

3 min read

China has dominated Myanmar’s rare earth mines — now India eyes deal to harness country’s critical minerals

India is deepening rare earth cooperation with Myanmar as New Delhi seeks alternative sources of critical minerals dominated by China, including dysprosium and terbium used in EVs, defence systems and clean energy technologies

6 min read

JPMorgan to hire 1,000 technology professionals for India GCCs amid AI-led transformation

Wall Street banking giant to expand hiring across cloud, cybersecurity and AI data pipeline roles as it strengthens its India Global Capability Centres despite AI-driven workforce optimisation.

1 min read

BOJ seen raising interest rates by December as weak yen fuels inflation risks

Majority of economists expect Japan's central bank to deliver a 25-basis-point rate hike by year-end, with further policy tightening likely through 2027.

2 min read

'From make in India to launch from India': Skyroot COO on why Vikram-1 could change India’s space sector

Skyroot Aerospace’s successful Vikram-1 mission marks a major milestone for India’s private space sector, as the country seeks to shift from “Make in India” to “Launch from India” and compete in the global commercial satellite launch market

8 min read

Up Next