Data integrity per se will not be an issue for big Indian pharma companies: Amit Rajan, Director, Celogen Life Sciences.

The decision was taken after the test reports showed that lead was present above the prescribed limit and also showed the presence of monos...

USFDA said it is looking to increase training and joint inspections in various areas, including manufacturing while also discussing possibi...

High-ranking officials of US health regulator USFDA will be travelling to India later this month to meet their senior regulatory counterpar...

The company has signed a memorandum of understanding (MoU) with the Gujarat government to train Gujarat Food and Drug Control Authority (FD...

UL claims to have trained over 36,000 USFDA investigators over the past two-three decades 'in an exclusive partnership'.

Marck Biosciences, now known as Amanta Healthcare received warning letter by US drug authority. USFDA found flase data and dead & decaying ...

The perception that India-made drugs are of “bad quality” is largely due to many related and unrelated convergence of events.

Rejecting US allegations related to intellectual property rights, India said that it is ready to discuss the matter at WTO as it has not br...

Taking up the case of domestic pharma sector with the US, India has pitched for review of America's whistle blower policy and lowering of r...

With almost 40 per cent of generic drugs dispensed in the US coming from India, the USFDA has to look at Indian pharma more closely.

The USFDA prohibited Ranbaxy Labs from manufacturing and distributing APIs from its Toansa plant for FDA-regulated drug products.

USFDA plans to conduct workshops across India in the next one year in order to sanitise Indian drug cos about the changing quality requirem...

Ghulam Nabi Azad did some plainspeak with the head of US drug regulator, asserting that Indian drugs should not be treated as spurious.

The matter came up during a meeting here between Commerce and Industry Minister Anand Sharma and USFDA Commissioner Margaret A Hamburg.

The US Food and Drug Administration has found arsenic content in about 30 samples ofIndian basmati rice in its preliminary analysis.

Shares of Sun Pharma rose 4% on Wednesday after the US drug regulator said it will import generic version of the cancer drug Lipidox.