Follow Us:
Tuesday, February 18, 2020

US FDA

US FDA NEWS

US FDA issues warning letters to Glenmark, Torrent

October 17, 2019 3:45 am

According to the letter issued to Glenmark, the company “failed to adequately investigate more than 70 consumer complaints associated with punctures, cracks, and holes” in some of the topical creams and ointments manufactured at its Baddi facility.

Explained: MDH masalas in US have tested positive for Salmonella. What is it?

September 13, 2019 11:42 am

This is not the first time that the American regulator has flagged problems of salmonella contamination in MDH products. The USFDA had detained imports of its spice products in over 20 instances between 2016 and 2018 for this reason.

US FDA says Indian drugmaker was shredding, dumping key documents

July 17, 2019 6:59 pm

Strides, which also has factories in Italy, Kenya and Singapore, produces drugs that treat AIDS, malaria and hepatitis.

Sun Pharma gets approval from US FDA for prostrate cancer drug

May 23, 2018 11:29 am

Sun Pharma's drug is a formulation to be used for the treatment of patients with metastatic castration-resistant prostate cancer.

2016 expectations: Pharma, infrastructure to pick up pace

January 15, 2016 1:28 am

As per a prominent investor, the market has seen a correction in 2015 and is expected to gain in 2016.

Wockhardt recalls products in US made at two units in Maharashtra

April 29, 2015 2:03 am

Wockhardt said this was a measure of preparedness and abundant precaution.

India, US seek to better drug-making processes

February 11, 2014 2:34 pm

No surprise checks on drug firms as US FAA and its Indian counterpart agree to coordinate in drug making.

High stakes

February 07, 2014 2:59 am

The government must overhaul the regulatory apparatus to prevent this from happening again.

Sun Pharma says issues with USFDA at Caraco facility addressed

October 28, 2013 3:11 pm

US FDA had conducted inspections in January and May this year and had noticed the lapses.

Ranbaxy shares tank nearly 14% as US-based facility comes under scanner

September 20, 2013 12:00 pm

The stock had plunged over 30% on Monday after USFDA issued an import alert for Ranbaxy's Mohali plant.