USFDA

Timeline of Maggi noodles' ban

Here is the timeline of the chain of events.

Aug 13, 2015, 15:33 PM IST

Impact of Maggi recall in India to continue in H2: Nestle

Swiss FMCG major Nestle on Thursday said the negative impact of withdrawal of Maggi in Indian market will continue in the second half of the year.

Aug 13, 2015, 15:18 PM IST

Relief for Nestle: Bombay HC lifts ban on Maggi, orders fresh test in 3 labs

High Court allowed Nestle to go in for fresh testing by sending five samples of each variant of noodles to three independent laboratories.

Aug 13, 2015, 14:29 PM IST

Bombay HC lifts ban on Maggi, orders fresh test

The court has given six weeks time to Nestle and said that the noodle samples will have to undergo fresh tests in three laboratories.

Aug 13, 2015, 09:36 AM IST

US health regulator says Maggi's lead content within acceptable levels

As a ban continues in India on Nestle's Maggi noodles, the US health regulator USFDA has said its tests have found the lead level in the popular instant food within acceptable levels for US consumers.

Aug 12, 2015, 11:58 AM IST

FDA hikes fee for drug approvals, cuts unit inspection charge

However, the fees for facility inspection of foreign companies have been reduced, which may encourage more firms to opt for audit of their facilities by the regulator.

Aug 05, 2015, 15:15 PM IST

Sun Pharma may file new drug application with USFDA: Shanghvi

India's largest drugmaker Sun Pharma may file application for a new drug with the US Food and Drug Administration in next two to three years, the company's Managing Director Dilip Shanghvi said on Thursday.

Jul 30, 2015, 20:47 PM IST

USFDA completes Nalagarh facility inspection: Wockhardt

Drug firm Wockhardt, which has been under the USFDA scanner, Thursday said that United States health regulator has completed inspection of its Nalagarh facility in Himachal Pradesh.

Jul 23, 2015, 20:34 PM IST

Wockhardt recalls over 1.62 lakh cartons of drugs in US

As per the information available on the US Food and Drug Administration's (USFDA) website, Mumbai-based Wockhardt is recalling the drugs for current good manufacturing practice (CGMP) deviations.

Jul 16, 2015, 19:05 PM IST

Zydus gets USFDA nod for morphine sulfate tablets

Pharmaceuticals major Zydus Group today announced receipt of approval to sell chronic pain reliever morphine sulfate tablets from the US Food and Drug Administration (USFDA).

Jul 01, 2015, 13:20 PM IST

Jubilant gets USFDA nod for generic levofloxacin tablets

The company has received approval from the US Food and Drug Administration (USFDA) to market generic version of Levaquin tablets in strengths of 250 mg and 500 mg in the American market, the firm said in a statement.

Jun 23, 2015, 15:39 PM IST

US court finds Copaxone patent invalid again: Natco Pharma

The Natco stock was trading at Rs 2,187.05, up 5.33 percent, on BSE at 1513 hours.

Jun 19, 2015, 15:34 PM IST

Glenmark gets USFDA final nod for contraceptive tablets

Glenmark Pharmaceuticals has received final nod from the US health regulator for generic oral contraceptive Levonorgestrel/Ethinyl Estradiol tablets and plans to commence shipping of the product immediately.

Jun 15, 2015, 15:44 PM IST

FDA upgrades Jubilant Life's US plant status

This upgradation by the USFDA from Official Action Indicated (OAI) to VAI is "indicative of the current good manufacturing practice (cGMP) status at the facility" since receiving the warning letter in 2013, the drug maker added.

Jun 12, 2015, 14:24 PM IST

US FDA testing Nestle's Maggi noodles after India recall

Nestle, the world`s largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores following reports by regulators that some packets contained excess lead. 

Jun 11, 2015, 17:14 PM IST

Focus on getting Ranbaxy's plants USFDA nod one at a time: Sun Pharma

The Mumbai-based drug major, which acquired Ranbaxy in a USD 4 billion deal, feels it is important for the merged entity to "re-establish" the trust between Ranbaxy and the US Food and Drug Administration (USFDA).

Jun 07, 2015, 14:41 PM IST

Two drugs manufactured by Wockhardt recalled in the US

According to information on the US Food and Drug Administration (USFDA) website, 166 bottles of Captopril tablets of 50 mg strength are being recalled in the US.

Jun 05, 2015, 19:22 PM IST

Cipla gets USFDA nod for Lopinavir, Ritonavir oral pellets

The company stock closed at Rs 634.90, down 0.95 per cent, on the BSE.

Jun 03, 2015, 17:06 PM IST

Wockhardt hopeful of early resolution of USFDA row

The company has now increased its R&D spend and filed more ANDAs in the US and Britain for approvals.

May 29, 2015, 16:25 PM IST

Glenmark gets USFDA nod for generic diabetes treatment drug

Shares of Glenmark Pharmaceuticals were trading at Rs 874.75 per scrip in afternoon trade, up 2.04 percent from the previous close on the BSE.

May 29, 2015, 12:49 PM IST