News for 'Ranbaxy's US Food and Drug Administration'

Sun Pharma draws up plan to fix ailing Ranbaxy

Sun Pharma draws up plan to fix ailing Ranbaxy

Rediff.com12 Sep 2014

It hopes to turn around Ranbaxy within four years of closing the deal by improving efficiency and resolving all regulatory issues

Wockhardt hit by FDA alert on another plant

Wockhardt hit by FDA alert on another plant

Rediff.com27 Nov 2013

Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.

India's drug inspectors hard-pressed to scrutinise factories

India's drug inspectors hard-pressed to scrutinise factories

Rediff.com7 Apr 2014

There are just 1,500 drug inspectors responsible for more than 10,000 factories in 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

India acts to repair reputation as drugs exporter

India acts to repair reputation as drugs exporter

Rediff.com7 May 2014

As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.

US FDA tightens regulatory noose on Indian drug firms

US FDA tightens regulatory noose on Indian drug firms

Rediff.com17 Sep 2013

Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter

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.

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.

Indian drug cos to benefit as US expedites generic clearances

Indian drug cos to benefit as US expedites generic clearances

Rediff.com12 May 2014

Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.

Compliance worries hit shares in India's top two drugmakers

Compliance worries hit shares in India's top two drugmakers

Rediff.com9 Nov 2015

Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform

Profit might be hit in FY16: Sun Pharma

Profit might be hit in FY16: Sun Pharma

Rediff.com21 Jul 2015

4 Ranbaxy facilities in India have been barred from exporting to US.

We will regain confidence of the US FDA: Dilip Shanghvi

We will regain confidence of the US FDA: Dilip Shanghvi

Rediff.com26 Mar 2015

'The focus for value creation will be on all business segments.'

Investors concerned about Wockhardt

Investors concerned about Wockhardt

Rediff.com17 Oct 2013

The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.

Daiichi drags Malvinder to Singapore court

Daiichi drags Malvinder to Singapore court

Rediff.com12 Nov 2013

In 2008, Daiichi Sankyo had bought the entire 34.82 per cent stake in Ranbaxy from its promoters, Malvinder Mohan Singh and family, for $4.2 billion. Currently, Singh is executive chairman of Fortis Healthcare.

Regulator might inspect Wockhardt units

Regulator might inspect Wockhardt units

Rediff.com12 Jun 2013

Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.

What exactly is wrong with India's pharma companies?

What exactly is wrong with India's pharma companies?

Rediff.com12 Sep 2017

Sun Pharma and Dr Reddy's top list in terms of those who face most class-action litigation

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.

'US FDA not on a witch hunt against India pharma firms'

'US FDA not on a witch hunt against India pharma firms'

Rediff.com23 Sep 2013

This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy

Now, US FDA gets a call from Indian pharma companies

Now, US FDA gets a call from Indian pharma companies

Rediff.com27 Oct 2013

The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it

Markets end flat on caution ahead of Fed, RBI meet

Markets end flat on caution ahead of Fed, RBI meet

Rediff.com16 Sep 2013

The broader markets ended negatively with mid-caps and small-caps shedding 0.5 per cent on the BSE.

How safe are cheap medicines made in India?

How safe are cheap medicines made in India?

Rediff.com11 Mar 2016

An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.

Sensex gains on Fed rally; posts best week since mid-June

Sensex gains on Fed rally; posts best week since mid-June

Rediff.com9 Oct 2015

Sensex, Nifty put up a good show in closing trade.

US FDA likely to inspect new Visakhapatnam arm of Divi's Labs in Jan

US FDA likely to inspect new Visakhapatnam arm of Divi's Labs in Jan

Rediff.com31 Dec 2013

The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.

Sun Pharma, Dr Reddy's price scrutiny in US reaches next level

Sun Pharma, Dr Reddy's price scrutiny in US reaches next level

Rediff.com21 Oct 2014

On October 2, a legislature committee wrote letters to the 14 companies, initiating an investigation and seeking details about recent price increases in several generic products available in the American market.

'It unfortunately became a feud between brothers'

'It unfortunately became a feud between brothers'

Rediff.com27 Sep 2018

'... And I don't think it really is that despite a lot going wrong.' 'Naiveté or stupidity or trusting the wrong person, the outcome is the same, which is that the group has gone to trash.' 'I'm not OK with people saying I had a role to play in crooking the system, which is not what I did.'

Drugmakers draw more FDA scrutiny as US imports rise

Drugmakers draw more FDA scrutiny as US imports rise

Rediff.com13 Sep 2013

And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.

3 Indian pharma firms named in US Congress price probe

3 Indian pharma firms named in US Congress price probe

Rediff.com9 Oct 2014

Details on prices sought as 10 generic drugs become up to 83 times costlier in 6 months

Wockhardt: Recovery not in sight yet

Wockhardt: Recovery not in sight yet

Rediff.com5 Nov 2014

The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.

FDA raises concern over US unit: Wockhardt

FDA raises concern over US unit: Wockhardt

Rediff.com28 May 2014

Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.

Pharma in 2014: Deals worth billions and fines worth millions

Pharma in 2014: Deals worth billions and fines worth millions

Rediff.com26 Dec 2014

In a surprise announcement in April, Sun and Ranbaxy -- at that time owned by Japan's Daiichi -- declared an all-stock deal to create India's largest and world's fifth-largest drugmaker in an over $4 billion deal.

Dilip Shanghvi's X factor shows up in different ways

Dilip Shanghvi's X factor shows up in different ways

Rediff.com13 Mar 2015

Dilip Shanghvi has never tried to be everything to everybody.

Keep us in loop before any FDA swoop, India tells US

Keep us in loop before any FDA swoop, India tells US

Rediff.com11 Feb 2014

Inspections only in domestic authorities' presence, visiting US drug regulator told

Rate-cut hopes drive markets higher; bluechips gain

Rate-cut hopes drive markets higher; bluechips gain

Rediff.com15 May 2015

Benchmark indices finished higher on hopes of economic reforms

Sensex ends flat after hitting life-time high of 28,283

Sensex ends flat after hitting life-time high of 28,283

Rediff.com18 Nov 2014

Roadshows will be held in Singapore, Hong Kong, London, New York and Boston, NTPC gained close to 1%.

Sensex, Nifty at their lowest close in 2015; bluechips drag

Sensex, Nifty at their lowest close in 2015; bluechips drag

Rediff.com8 Jun 2015

Markets ended their lowest close in 2015 on fears of FII outflows as the US Fed may hike rates.

Why Sunil Munjal is keen to acquire Fortis

Why Sunil Munjal is keen to acquire Fortis

Rediff.com17 Apr 2018

According to Munjal, there is an opportunity for somebody who comes from a not for profit background in health care to do something.

Sensex gains 65 points; Nifty ends above 8,100

Sensex gains 65 points; Nifty ends above 8,100

Rediff.com12 Sep 2014

The top gainers on the Sensex were Cipla, Bharti Airtel, Maruti Suzuki, Hero Moto & Sesa Sterlite.

Sensex plunges for 3rd day; IT pack leads fall on TCS let-down

Sensex plunges for 3rd day; IT pack leads fall on TCS let-down

Rediff.com17 Apr 2015

The 30-share Sensex ended down 224 points at 28,442 and the 50-share Nifty ended down 101 points at 8,606.

How Malvinder and Shivinder Singh destroyed the legacy they inherited

How Malvinder and Shivinder Singh destroyed the legacy they inherited

Rediff.com27 Mar 2018

Over-expansion, bad management, and multiple allegations irreparably taint Malvinder and Shivinder Singh

Markets end at record highs; ITC, banks outperform

Markets end at record highs; ITC, banks outperform

Rediff.com27 Jan 2015

The 30-share Sensex ended up 292 points at 29,571 and the 50-share Nifty closed up 75 points at 8,910.