News for 'US Food and Drug Administration'

Third dose of COVID vaccine 'likely' needed within 1 year: Pfizer boss

Third dose of COVID vaccine 'likely' needed within 1 year: Pfizer boss

Rediff.com16 Apr 2021

Health officials have previously raised the possibility that the public may need booster COVID-19 shots.

Maha portfolios: Sena gets home, NCP finance, Cong revenue

Maha portfolios: Sena gets home, NCP finance, Cong revenue

Rediff.com13 Dec 2019

Portfolios were distributed 2 weeks after the MVA govt was sworn-in. Shiv Sena's Eknath Shinde will be home minister while NCP's Jayant Patil will be finance minister.

Infosys, L&T are top picks of most brokerages for Samvat 2078

Infosys, L&T are top picks of most brokerages for Samvat 2078

Rediff.com12 Nov 2021

Despite unprecedented levels of uncertainty in Samvat 2077, investors have little to complain about on the returns front. The BSE Sensex delivered returns of 38 per cent in this period, while the Nifty registered a return of over 40 per cent. As is the case in bull markets, companies in the small- and mid-capitalisation basket outperformed the benchmarks, with returns almost twice those of frontliners.

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.

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.

20-30% new products may be open to USFDA inspection

20-30% new products may be open to USFDA inspection

Rediff.com23 May 2022

With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.

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.

PE/VC investments in pharma cos cross $1 bn mark

PE/VC investments in pharma cos cross $1 bn mark

Rediff.com6 Oct 2020

Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.

Oxford jabs effective against severe Covid: US trial

Oxford jabs effective against severe Covid: US trial

Rediff.com22 Mar 2021

The Oxford/AstraZeneca vaccine is also being produced as part of a tie-up by the Serum Institute of India.

US FDA conducts surprise inspection of Dr Reddy's Vizag plant

US FDA conducts surprise inspection of Dr Reddy's Vizag plant

Rediff.com20 Nov 2014

The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes

More trouble for Ranbaxy; Mohali unit may also have come under USFDA lens

More trouble for Ranbaxy; Mohali unit may also have come under USFDA lens

Rediff.com24 Jun 2013

FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.

Dilip Shanghvi's success: From a start-up to India's largest drug maker

Dilip Shanghvi's success: From a start-up to India's largest drug maker

Rediff.com11 Mar 2015

Dilip Shanghvi founded Sun Pharma in 1983.

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.

Karnataka, Gujarat lift ban on Maggi

Karnataka, Gujarat lift ban on Maggi

Rediff.com19 Oct 2015

The state government had in the first week of June banned Maggi sale in the state after the product failed the food safety test.

'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.

Ranbaxy stock ends nearly 4% down post Sun Pharma deal

Ranbaxy stock ends nearly 4% down post Sun Pharma deal

Rediff.com7 Apr 2014

Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.

Gutka sale will soon be a non-bailable offence in Maharashtra

Gutka sale will soon be a non-bailable offence in Maharashtra

Rediff.com23 Mar 2015

The sale of gutka would be booked under non-bailable sections regarding the offence

Johnson & Johnson allowed to manufacture and sell baby powder

Johnson & Johnson allowed to manufacture and sell baby powder

Rediff.com11 Jan 2023

The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.

Novovax Covid vaccine likely to get nod in India ahead of US

Novovax Covid vaccine likely to get nod in India ahead of US

Rediff.com18 Aug 2021

Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.

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.

India lifts temporary ban on supply of hydroxychloroquine

India lifts temporary ban on supply of hydroxychloroquine

Rediff.com7 Apr 2020

India on Tuesday temporarily licensed the export of paracetamol and anti-malarial drug Hydroxychloroquine in appropriate quantities to some countries, which have been particularly badly affected by the coronavirus pandemic.

WHO clears Serum Institute's Covovax for emergency use

WHO clears Serum Institute's Covovax for emergency use

Rediff.com18 Dec 2021

'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.

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."

We will prevail: Trump hints at 2024 presidential bid

We will prevail: Trump hints at 2024 presidential bid

Rediff.com1 Mar 2021

Speaking at the Conservative Political Action Committee in Orlando, Florida on Sunday, the 74-year-old leader, who left the White House on January 20, stopped short of announcing to run for the president in 2024, although he gave enough indications that he is moving in that direction.

Covishield accounts for 88% of Covid jabs in India

Covishield accounts for 88% of Covid jabs in India

Rediff.com1 Jan 2022

Serum Institute has the capacity to make 250 million doses of Covishield monthly.

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

Ranbaxy woes continue to dog Sun Pharma

Ranbaxy woes continue to dog Sun Pharma

Rediff.com29 Oct 2015

The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.

Pfizer withheld Covid vaccine news before elections: Trump

Pfizer withheld Covid vaccine news before elections: Trump

Rediff.com10 Nov 2020

Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.

USFDA issues import alert on Ranbaxy's Mohali plant

USFDA issues import alert on Ranbaxy's Mohali plant

Rediff.com16 Sep 2013

While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.

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.

Now, Goa bans sale of Maggi; 11th state to ban noodle brand

Now, Goa bans sale of Maggi; 11th state to ban noodle brand

Rediff.com7 Jun 2015

Goa on Sunday joined several other states in banning the sale of Nestle's instant noodle brand 'Maggi' which is at the centre of a raging nationwide row over food safety concerns.

USFDA raises concerns about Ranbaxy's Toansa plant

USFDA raises concerns about Ranbaxy's Toansa plant

Rediff.com13 Jan 2014

All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.

Chemists call for nationwide strike on Oct 14

Chemists call for nationwide strike on Oct 14

Rediff.com1 Oct 2015

The introduction of e-pharmacy, to protect the interest of a handful of players, would hamper the interest of 800,000 chemists and 80 lakh workers and their families

US lifts mask guidance for fully vaccinated people

US lifts mask guidance for fully vaccinated people

Rediff.com14 May 2021

The recommendation holds true for both indoors and outdoors, the CDC said.

Aurobindo, Glenmark, Natco get USFDA nod for migraine tablets

Aurobindo, Glenmark, Natco get USFDA nod for migraine tablets

Rediff.com2 Jul 2013

Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.

This simple TIP will help you fight coronavirus

This simple TIP will help you fight coronavirus

Rediff.com4 Mar 2020

Meticulous hand washing is your best bet to get rid of the grime that clings to the hand, that might harbour nasty pathogens, including the coronavirus.

Army asks personnel not to consume Maggi

Army asks personnel not to consume Maggi

Rediff.com3 Jun 2015

The Indian Army on Wednesday issued an advisory asking its personnel not to consume Maggi noodles.

Indian-American physician named co-chair of Biden's Covid task-force

Indian-American physician named co-chair of Biden's Covid task-force

Rediff.com9 Nov 2020

Dr Murthy, 43, a former United States Surgeon General, along with two other co-chairs -- Dr David Kessler and Dr Marcella Nunez-Smith -- would lead a team of leading public health experts who will advise Biden and Vice President-elect Kamala Harris on the deadly virus.

US VP-elect Kamala Harris receives first dose of Moderna COVID-19 vaccine

US VP-elect Kamala Harris receives first dose of Moderna COVID-19 vaccine

Rediff.com30 Dec 2020

The US vice-president-elect received a dose of the Moderna vaccine from clinical nurse Patricia Cummings at United Medical Center, which is located in Southeast Washington, DC.

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rediff.com12 Oct 2015

Rosier year-end seen for Indian pharma thanks to faster US approvals.