Indian markets are set for a dynamic start today. Investors will closely watch the Q4 results from banking giants HDFC Bank and ICICI Bank....

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

The company is still resolving issues with US Free Trade Commission for the Sandoz acquisition.

Aurobindo Pharma plunged 19% after USFDA flagged lack of good manufacturing practices at the Telangana plant.

US health regulator has issued 12 observations after the inspection of three of Biocon's units in Malaysia.

As per the USFDA, a Form 483, is issued to a firm's management at the conclusion of an inspection when investigator has observed any condit...

The observations are not material in nature, the company said.

US FDA investigation and observations have material impact on stock prices.

The FDA inspection took place on May 25, June 1 and June 3.

There are no appropriate control procedures established over computers or related systems,USFDA observed.

As per the USFDA, observations are made in Form 483 when investigators feel that practices in the facility are such that products may becom...

The audit of our formulations manufacturing plant-3 at Bachupally, Hyderabad by the USFDA has been completed today, said Dr Reddy's Lab.

Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observ...

The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations.

The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Ph...

The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plan...

The company received three observations relating to violation of production norms at manufacturing facilities at Mandideep, Madhya Pradesh ...