Dabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...

The US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...

There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...

The U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...

In a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversig...

Aurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and Septem...

The US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatna...

Aurobindo Pharma has received a Form 483 with one observation from the US FDA after an inspection of its formulation production facility in...

With India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...

As Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...

Since the Generic Drug User Fee Amendments implementation in Oct 2012, FDA inspections have doubled in India and China, which led to consid...

The US drug regulator had imposed an import alert on the facility following issues related to manufacturing violations.

The U.S. regulator had in January banned imports from a separate central Indian manufacturing plant of Ipca, citing violations of standard ...

"USFDA is in the process of taking the headcount up to 19. We have offices in New Delhi and Mumbai. Currently we have 9 or 10 (officials wo...

The US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...

The Rs 1000 crore generic pharma company has received US FDA inspection approval status for its steriles injectable complex at Bangalore.

The US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...