News for 'us-food-and-drugs-administration'

SPARC shares surge 15%; m-cap up by Rs 1,685 cr

SPARC shares surge 15%; m-cap up by Rs 1,685 cr

Rediff.com9 Mar 2015

The company's market value rose by Rs 1,684.87 crore.

China rolls out first one-jab COVID-19 vaccine: Report

China rolls out first one-jab COVID-19 vaccine: Report

Rediff.com28 Feb 2021

China has given conditional approval for a single dose COVID-19 vaccine, touted to be a rival to Johnson & Johnson's one-jab shot cleared by the United States drug regulator on Sunday.

Sun Pharma settles litigation with Novartis over cancer drug

Sun Pharma settles litigation with Novartis over cancer drug

Rediff.com15 May 2014

One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.

US regulator urges USV to probe staff for inaccurate data reporting

US regulator urges USV to probe staff for inaccurate data reporting

Rediff.com5 Mar 2014

The US Food and Drug Administration has asked USV to probe employees who might have been responsible for inaccurate data reporting.

US court rejects Ranbaxy' plea to block launch by rival cos

US court rejects Ranbaxy' plea to block launch by rival cos

Rediff.com20 Nov 2014

US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.

Govt approves 2 new vaccines, Covid drug for emergency use

Govt approves 2 new vaccines, Covid drug for emergency use

Rediff.com28 Dec 2021

The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.

Wockhardt gets import alert from US FDA

Wockhardt gets import alert from US FDA

Rediff.com6 Aug 2016

Ankleshwar plant is the third such facility to face action

Sun Pharma seeks shareholders' nod for Rs 12,000-crore QIP

Sun Pharma seeks shareholders' nod for Rs 12,000-crore QIP

Rediff.com12 Sep 2014

Sun Pharma stated the company wanted shareholders' approval to "issue, offer and allot equity shares or non-convertible securities, other than warrants, up to an amount of Rs 12,000 crore ($2 billion), to qualified institutional buyers pursuant to a QIP."

Trump suggests injecting disinfectant as COVID-19 treatment

Trump suggests injecting disinfectant as COVID-19 treatment

Rediff.com24 Apr 2020

Trump also raised the possibility of using light to combat the deadly viral infection.

Wockhardt to recall some drugs made in India

Wockhardt to recall some drugs made in India

Rediff.com28 Apr 2015

Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.

Trump requests Modi to release Hydroxychloroquine ordered by US

Trump requests Modi to release Hydroxychloroquine ordered by US

Rediff.com5 Apr 2020

India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis. With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.

Wockhardt gets warning letter from USFDA over Waluj plant

Wockhardt gets warning letter from USFDA over Waluj plant

Rediff.com20 Jul 2013

The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.

US VP Mike Pence receives COVID-19 vaccine on camera

US VP Mike Pence receives COVID-19 vaccine on camera

Rediff.com18 Dec 2020

"Confidence in the vaccine is what brings us here this morning," the US vice-president said in remarks following his vaccination. "I didn't feel a thing. Well done."

Sanjay Valvani, New York hedge fund exec found dead in apparent suicide

Sanjay Valvani, New York hedge fund exec found dead in apparent suicide

Rediff.com22 Jun 2016

Prosecutors unveiled charges against Valvani alleging he fraudulently made $25 million by getting advance information about US Food and Drug Administration approvals of generic drug applications

SC to hear plea against Ranbaxy on June 24

SC to hear plea against Ranbaxy on June 24

Rediff.com17 Jun 2013

The case was earlier heard by a different vacation bench which had on June 10 asked Sharma to substantiate his 'unfounded allegations' that the Indian pharma major was allegedly manufacturing and selling adulterated medicines.

Ranbaxy recalls 29,790 packs of anti-allergy drug in US

Ranbaxy recalls 29,790 packs of anti-allergy drug in US

Rediff.com2 May 2014

Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.

Sun Pharma hit by FDA ban on Gujarat plant, shares fall

Sun Pharma hit by FDA ban on Gujarat plant, shares fall

Rediff.com13 Mar 2014

Recently, Ranbaxy and Wockhardt too were hauled up.

Ranbaxy stock nosedives 20% on USFDA restrictions

Ranbaxy stock nosedives 20% on USFDA restrictions

Rediff.com24 Jan 2014

Shares of Ranbaxy Laboratories on Friday slumped as much as 20 per cent in the morning trade after the USFDA prohibited the company from producing and distributing drugs for the American market from its Toansa plant in Punjab.

US warns Novartis on manufacturing violations at 2 India plants

US warns Novartis on manufacturing violations at 2 India plants

Rediff.com28 Oct 2015

US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.

Ranbaxy gets FDA nod to sell generic Diovan tablets in US

Ranbaxy gets FDA nod to sell generic Diovan tablets in US

Rediff.com27 Jun 2014

Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.

Centre may not get costly Pfizer vaccine

Centre may not get costly Pfizer vaccine

Rediff.com22 Dec 2020

At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.

Hydroxychloroquine doesn't help treat COVID-19: Report

Hydroxychloroquine doesn't help treat COVID-19: Report

Rediff.com22 Apr 2020

Trump has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients.

Lupin gets USFDA nod to market HIV drug in US

Lupin gets USFDA nod to market HIV drug in US

Rediff.com10 Dec 2013

The company has received final approval from the US Food and Drug Administration for its Abacavir Sulfate Lamivudine, and Zidovudine Tablets, Lupin Ltd said in a statement.

Hydroxychloroquine consignment from India arrives in US

Hydroxychloroquine consignment from India arrives in US

Rediff.com12 Apr 2020

Hydroxychloroquine has been identified by the US Food and Drug Administration as a possible treatment for the COVID-19 and it is being tested on more than 1,500 coronavirus patients in New York.

Watson sends patent challenge notice to Ranbaxy for acne drug

Watson sends patent challenge notice to Ranbaxy for acne drug

Rediff.com20 Sep 2013

The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.

Drug regulator to make routine inspection of Chinese suppliers

Drug regulator to make routine inspection of Chinese suppliers

Rediff.com15 Nov 2013

Move follows a spate of international regulatory enforcements on Indian drug firms.

Coronavirus crisis could stretch up to August, warns Trump

Coronavirus crisis could stretch up to August, warns Trump

Rediff.com17 Mar 2020

At least 85 people have died of coronavirus with the confirmed cases crossing 4,500 in the US.

Regulator finds procedural lapses at Wockhardt's US facility

Regulator finds procedural lapses at Wockhardt's US facility

Rediff.com3 Jun 2014

The FDA had imposed a ban on the company's Waluj plant in May.

ICMR to conduct nationwide sero surveys on Covid spread

ICMR to conduct nationwide sero surveys on Covid spread

Rediff.com12 Jun 2021

The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.

Top US doctor cautiously optimistic over COVID vaccine

Top US doctor cautiously optimistic over COVID vaccine

Rediff.com9 Jul 2020

There are a number of vaccine candidates already in clinical trial and a few out of those candidates have completed phase 1/2 status, he said, adding that there are trials that will be going into phase three sometime at the end of July and then others will follow in the months of August, September and October.

After US, Germany bans export of Ranbaxy's Dewas plant drugs

After US, Germany bans export of Ranbaxy's Dewas plant drugs

Rediff.com3 Dec 2014

The company did not comply to the 'good manufacturing practice' norms.

US regulator fast-tracks approval for Wockhardt drugs

US regulator fast-tracks approval for Wockhardt drugs

Rediff.com1 Sep 2014

These drugs will be entering in their global Phase -3 clinical trials early next year.

Indian regulator also scans Ranbaxy

Indian regulator also scans Ranbaxy

Rediff.com20 Sep 2013

The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.

J&J's loss may be good news for Indian pharmas

J&J's loss may be good news for Indian pharmas

Rediff.com1 Nov 2018

Dr Reddy's, Glenmark, Wockhardt have lined up alternatives for Zytiga

'Famotidine may become the next HCQ for Covid-19'

'Famotidine may become the next HCQ for Covid-19'

Rediff.com10 May 2020

Researchers at Northwell Health in New York are testing the effects on Famotidine (used in high intravenous doses) on Covid-19 patients as a potential treatment. After the hospital announced its clinical trials, it led to a drug shortage in the US. Back home, however, there has not been any surge in the demand for Famotidine yet.

US regulator not happy with Sun Pharma's reply on import alert

US regulator not happy with Sun Pharma's reply on import alert

Rediff.com21 May 2014

In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.

Ranbaxy Q4 net loss at Rs 73.6 crore

Ranbaxy Q4 net loss at Rs 73.6 crore

Rediff.com9 May 2014

It had posted net profit of Rs 125.75 crore (Rs 1.25 billion) during the January-March quarter of the previous fiscal, 2012-13.

Aurobindo Pharma embroiled in patent cases in the US

Aurobindo Pharma embroiled in patent cases in the US

Rediff.com28 Apr 2014

According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.

US drug regulator warns RPG Life Sciences

US drug regulator warns RPG Life Sciences

Rediff.com19 Jun 2013

The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.

Cadila believes it has silver bullet to fight COVID-19

Cadila believes it has silver bullet to fight COVID-19

Rediff.com21 Apr 2020

Can Interferon alfa-2b treat COVID-19 effectively?