483

The company has a strong pipeline of products which the company, CMD Glenn Saldanha said adding that new launches will drive earnings for the company in FY18 and FY19. The company has no plans to raise further capital, he said.

FDA 483s on Indoco plant not related to data integrity issues

US FDA inspected the Goa plant II for five days starting from August 31. Injectable Abbreviated New Drug Application (ANDA) filings had triggered the US FDA to inspect the plant.

Indoco Remedies up 12% after Goa unit gets six 483s from USFDA

All the observations (483s) are correctable and the company expects to complete the corrective and preventive actions within a period of 30 days, it said, adding none of the 483s were related to data integrity issue.

Approval for more than 60 ANDAs pending: DRL

Over the last few months there have been 5 or 6 audits. Since DRL has invested quite significantly in terms of the cultural transformation in quality area, it got some of the places zero 483 which is uncommon, says CFO Saumen Chakraborty.