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

Sun Pharma to delist Ranbaxy on completion of $4-bn merger

Sun Pharma to delist Ranbaxy on completion of $4-bn merger

Rediff.com25 Mar 2015

The merger has fortified Sun Pharma's position.

Ranbaxy brand may fade away as Sun takes charge

Ranbaxy brand may fade away as Sun takes charge

Rediff.com10 Dec 2014

The joint entity will have a market share of nine per cent in India. Analysts tracking the company said one of the key outcomes of the merger would be to create a single brand entity of Sun and the Ranbaxy brand would eventually dissolve.

Ranbaxy's Singh brothers told to pay Rs 2,562-crore fine to Daiichi

Ranbaxy's Singh brothers told to pay Rs 2,562-crore fine to Daiichi

Rediff.com6 May 2016

In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.

Meet the man behind the Sun Pharma-Ranbaxy deal

Meet the man behind the Sun Pharma-Ranbaxy deal

Rediff.com8 Apr 2014

Sun Pharma's offer was tempting because Ranbaxy was too busy fighting fires in the US to concentrate on operations.

Ranbaxy hires BCG, Mercer for internal strategic project

Ranbaxy hires BCG, Mercer for internal strategic project

Rediff.com1 Jun 2013

Consultants are working with various teams on manufacturing, R&D, etc, to assess per-month productivity of each department.

Ranbaxy's top executives in the US resign

Ranbaxy's top executives in the US resign

Rediff.com14 Oct 2014

US country head, key departmental heads leave; more likely to follow.

Sun-Ranbaxy deal signals Indian pharma cos are smart targets

Sun-Ranbaxy deal signals Indian pharma cos are smart targets

Rediff.com8 Apr 2014

The Ranbaxy experience has made multinational corporations more cautious about Indian acquisitions in general

Religare's banking bid under Ranbaxy cloud

Religare's banking bid under Ranbaxy cloud

Rediff.com1 Jun 2013

Singh brothers might be stopped by 'fit & proper' hurdle due to US drug norm violations; firm says confident of qualifying.

US drug regulator finds Indian companies critically ill

US drug regulator finds Indian companies critically ill

Rediff.com24 Sep 2013

The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.

Pharma crusader takes India's drug regulators to court

Pharma crusader takes India's drug regulators to court

Rediff.com7 Mar 2016

Dinesh Thakur is famous for exposing Ranbaxy safety problems

Sun Pharma ends patent dispute with Actavis

Sun Pharma ends patent dispute with Actavis

Rediff.com6 Oct 2015

Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.

Daiichi was given all updates: Malvinder Singh

Daiichi was given all updates: Malvinder Singh

Rediff.com24 May 2013

Singh says Japanese pharma giant's allegations false.

Sun gets US trade regulator nod for Ranbaxy merger

Sun gets US trade regulator nod for Ranbaxy merger

Rediff.com1 Feb 2015

Torrent to buy Ranbaxy's anti-bacterial generic

Suspected human hair in tablet cited in Ranbaxy ban

Suspected human hair in tablet cited in Ranbaxy ban

Rediff.com18 Sep 2013

Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co and gets more than 40 per cent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.

Lupin recalls 9,210 bottles of anti-infective drug from the US

Lupin recalls 9,210 bottles of anti-infective drug from the US

Rediff.com15 Apr 2014

The recent recalls come amid increased FDA scrutiny of medicines produced in India.

Sun-Ranbaxy merger may spill over to 2015

Sun-Ranbaxy merger may spill over to 2015

Rediff.com15 Nov 2014

The Competition Commission of India and the US Federal Trade Commission are yet to give their nod to the biggest pharma merger and acquisition deal this year in the Asia-Pacific region.

Why Daiichi is taking Malvinder Singh to court

Why Daiichi is taking Malvinder Singh to court

Rediff.com27 Nov 2013

The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.

Ranbaxy gets important breather

Ranbaxy gets important breather

Rediff.com11 Oct 2013

Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.

Daiichi pursuing legal action on ex-shareholders

Daiichi pursuing legal action on ex-shareholders

Rediff.com23 May 2013

Says former Ranbaxy owners concealed critical information on probe by US agencies.

Now, Pfizer, Novartis, GSK under USFDA scanner

Now, Pfizer, Novartis, GSK under USFDA scanner

Rediff.com19 Jul 2008

Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.

Cloud over US FDA inspection

Cloud over US FDA inspection

Rediff.com19 Jul 2008

Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.

Don't need to sell assets, can pay fine: Ranbaxy brothers

Don't need to sell assets, can pay fine: Ranbaxy brothers

Rediff.com25 May 2016

In 2013, Daiichi had launched the arbitration proceedings in Singapore.

Indian drug makers face heat of US regulator's crackdown

Indian drug makers face heat of US regulator's crackdown

Rediff.com23 Jun 2013

Data also show that several other leading domestic pharma companies have recalled their products from the US

It's a tough road ahead for pharma companies

It's a tough road ahead for pharma companies

Rediff.com29 May 2013

Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.

Wait for Indian generic launches gets longer

Wait for Indian generic launches gets longer

Rediff.com29 Oct 2012

USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.

40 years ago and now: How Ranbaxy moved out of family control

40 years ago and now: How Ranbaxy moved out of family control

Rediff.com22 Oct 2014

Ranbaxy did its maiden public issue in 1973.

Daiichi-Ranbaxy row: HC orders attachment of assets

Daiichi-Ranbaxy row: HC orders attachment of assets

Rediff.com26 Feb 2018

The court also restrained RHC Holdings from operating its bank accounts except for payment of salaries and statutory dues till March 23, the next date of hearing.

US regulator tightens drug approval norms

US regulator tightens drug approval norms

Rediff.com29 Jul 2013

Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics

Sklamberg on challenges the US drug regulator faces globally

Sklamberg on challenges the US drug regulator faces globally

Rediff.com19 Mar 2015

The US Food and Drug Administration (FDA) says it does not follow an India agenda.

Indian pharma companies bullish in the US

Indian pharma companies bullish in the US

Rediff.com6 Mar 2009

Despite the ongoing trouble India's largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world's largest drug market with added vigour.

India raises concerns over FDA actions on domestic drug firms

India raises concerns over FDA actions on domestic drug firms

Rediff.com10 Feb 2014

India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.

Indian pharma prefers non-litigation route in US

Indian pharma prefers non-litigation route in US

Rediff.com22 Nov 2007

The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy's at having secured over 20 first to file status abbreviated new drug applications with the US Food and Drug Administration.

Rs 3,500-cr fine on Singh bros, not Rs 2,562 cr: Daiichi

Rs 3,500-cr fine on Singh bros, not Rs 2,562 cr: Daiichi

Rediff.com7 May 2016

Daiichi alleged that Singh brothers had concealed and misrepresented critical information concerning US Food and Drug Administration and Department of Justice investigations into Ranbaxy

'Premature to talk of changes in Ranbaxy top brass now'

'Premature to talk of changes in Ranbaxy top brass now'

Rediff.com14 Apr 2014

Sun Pharmaceutical Industries will take a call on whether to shut Ranbaxy's troubled factories or make changes in the top management of the latter only after its $4-billion acquisition deal is complete.

After ban on drug facilities, US regulator comes calling

After ban on drug facilities, US regulator comes calling

Rediff.com10 Feb 2014

Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.

FDA finds contaminated drug ingredient at GSK Ireland plant

FDA finds contaminated drug ingredient at GSK Ireland plant

Rediff.com2 Apr 2014

The FDA has stepped up its efforts to ensure drug safety in recent months.

As drug firms squirm, authorities look abroad for cure

As drug firms squirm, authorities look abroad for cure

Rediff.com23 Sep 2013

DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices

Less competition, demand-supply gap push US drug prices

Less competition, demand-supply gap push US drug prices

Rediff.com13 Oct 2014

Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.

Local drug makers worried as regulators start working together

Local drug makers worried as regulators start working together

Rediff.com26 Dec 2013

Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.