As global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.

India and New Zealand will sign a Free Trade Agreement on Monday, April 27. This landmark deal aims to boost bilateral trade significantly....

Over 67,000 cases of Power Stick deodorant sold at major retailers like Walmart, Amazon, and Dollar Tree have been voluntarily recalled. Th...

USFDA's action follows inspections at the facilities of Ahmedabad-based Synchron and Navi Mumbai-based Panexcell, as well as its own analys...

Earlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.

Established in 1995, Fleming Laboratories is in the business of manufacturing and supply of generic Active Pharmaceutical Ingredients (APIs...

With four sessions remaining for the year to end, the Nifty Pharma index is down 17.3% so far in 2016, compared to the Nifty which is down ...

The Maharashtra Food and Drug Administration’s finding that Wanbury shipped to four countries batches of metformin hydrochloride produced b...

USFDA releases a copy of the Establishment Inspection Report to the establishment that was the subject of an FDA or FDA-contracted inspecti...

US health regulator has issued an import alert against Pune-based Emcure Pharmaceuticals for products made at its plant in Hinjwadi, Pune.

It could also help such a company get more flexibility should it seek some 'manufacturing changes' even after a drug is approved.

Indian drugmakers continue to find themselves on the wrong side of global regulators, with the latest being Maharashtra-based Bliss GVS Pha...

FDA has named at least five Indian companies among 43 drugmakers that have failed to meet their annual facility fee payment obligations.

USFDA has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants ...

The US drug regulator has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies...

"The reality at present is that the pharma stocks are always subject to problems with US FDA regulations," says Sajiv Dhawan of JV Capital.

The US health regulator has served a warning letter on the American unit of Mumbai-based drug major Sun Pharma for violating good manufactu...