News for 'Food and Drug Administration'

Cadbury's 2nd plant under lens

Cadbury's 2nd plant under lens

Rediff.com6 Oct 2003

AFI chief warns athletes not to take banned drugs by taking advantage of COVID-19 pandemic

AFI chief warns athletes not to take banned drugs by taking advantage of COVID-19 pandemic

Rediff.com31 Oct 2020

AFI President Adille Sumariwalla raised the possibility of more athletes outside the national camp taking to banned drugs and laid a lot of blame on the district and state level coaches.

Manikchand's mineral water under lens

Manikchand's mineral water under lens

Rediff.com23 Jul 2004

The Maharashtra Food and Drug Administration has issued a show cause notice to a Pune-based diversified group for putting 'objectionable' label in its bottled mineral water and seized water bottles worth Rs 245,000 from Aurangabad.

Cipla gets nod to import Moderna vaccine for emergency use in India

Cipla gets nod to import Moderna vaccine for emergency use in India

Rediff.com29 Jun 2021

India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.

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.

Glenmark gets USFDA final nod for contraceptive tablets

Glenmark gets USFDA final nod for contraceptive tablets

Rediff.com15 Jun 2015

It is the generic version of Teva Women's Health's Seasonale tablets

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.

USFDA rejected 12,012 Indian products since January 2011

USFDA rejected 12,012 Indian products since January 2011

Rediff.com2 May 2016

The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products.

Gutkha worth over Rs 7 lakh seized in Maharashtra

Gutkha worth over Rs 7 lakh seized in Maharashtra

Rediff.com1 Feb 2005

The Maharashtra Food and Drug Administration seized gutkha worth over Rs 7 lakh from various parts of the state over the last two days in an effort to enforce the ban on gutkha sales.

USFDA denies Covaxin emergency use nod, to take 'full approval' route

USFDA denies Covaxin emergency use nod, to take 'full approval' route

Rediff.com11 Jun 2021

In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

Aurobindo Pharma gets nod for AIDS tablets

Aurobindo Pharma gets nod for AIDS tablets

Rediff.com28 Jun 2013

The company has received the tentative approval from the US Food & Drug Administration to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg, a statement by Aurobindo Pharma said.

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

Why investors are regretting giving Gland Pharma IPO a miss

Why investors are regretting giving Gland Pharma IPO a miss

Rediff.com24 Nov 2020

Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.

Lupin launches generic Ciprofloxacin in US market

Lupin launches generic Ciprofloxacin in US market

Rediff.com13 Jun 2014

The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.

Dr Reddy's A-team moves on putting house in order

Dr Reddy's A-team moves on putting house in order

Rediff.com10 Oct 2018

After spending considerable time and energy in remediation efforts in the wake of the US Food and Drug Administration's warning letter on compliance issues, the company's leadership has finally set out to bring the house in order.

US approves Johnson & Johnson's Covid vaccine

US approves Johnson & Johnson's Covid vaccine

Rediff.com28 Feb 2021

The Johnson and Johnson vaccine, which works with one dose instead of two, got approval on Saturday, the third vaccine cleared in the country after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.

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.

Maharashtra government bans Maggi

Maharashtra government bans Maggi

Rediff.com6 Jun 2015

Maharashtra government on Friday decided to put a ban on Maggi noodles after some samples were found to contain lead above the permissible limit.

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.

Hydroxychloroquine can be fatal: Experts

Hydroxychloroquine can be fatal: Experts

Rediff.com6 May 2020

As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.

Engaged with US entities for procurement of vaccines: MEA

Engaged with US entities for procurement of vaccines: MEA

Rediff.com20 May 2021

India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.

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

Why Sun Pharma stock will remain under pressure

Why Sun Pharma stock will remain under pressure

Rediff.com24 Dec 2019

The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.

FIR filed against Snapdeal CEO, directors

FIR filed against Snapdeal CEO, directors

Rediff.com1 May 2015

In April, Snapdeal had said it was delisting the drugs from its portal and was assisting the regulator in the investigation.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

'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.

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.