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.
Brian Tempest is among the four directors of cash-strapped healthcare chain whose removals were sought by two institutional investors. Three directors -- Harpal Singh, Sabina Vaisoha and Tejinder Singh Shergill -- had already resigned before the EGM.
Ties between India and the United States have been strained in recent years because of trade policies and patent disputes.
Data also show that several other leading domestic pharma companies have recalled their products from the US
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
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The report comes at a time when the government is trying to clear pending FDI proposals, which include various planned investments in this sector.
Dinesh Thakur is famous for exposing Ranbaxy safety problems
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.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
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.
The FDA has stepped up its efforts to ensure drug safety in recent months.
Hit by the new drug pricing policy and regulatory interventions, growth rate of the Rs 72,069-crore Indian pharmaceutical market has slowed down to 9.8 per cent in 2013 as compared to 16.6 per cent in 2012, says a report.
Launches cloud-based version of solution to target mid-size clients in life sciences.
Minority shareholders of Hyderabad-based Zenotech Laboratories, a biotech company in which Ranbaxy owns 46.8 per cent, are up in arms against Ranbaxy's new owner Daiichi Sankyo for allegedly failing to buy additional shares at the price offered by the former promoters of Ranbaxy.
Benchmark indices finished higher on hopes of economic reforms
'The failures of private businessmen have set back the process of market-oriented reform, though that is the only way forward,' argues T N Ninan.
The year saw 30 QIP deals raising over $5 billion and 35 IPOs.
Sun Pharma has evinced its interest in buying Hyderabad-based biotech company Zenotech Laboratories, through an open offer to buy 28.1 per cent worth Rs 18.41 crore ($3 million).
Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.
Over-expansion, bad management, and multiple allegations irreparably taint Malvinder and Shivinder Singh
In October 2007, Ranbaxy Laboratories picked up a 38 per cent additional stake in the company, taking its shareholding in the Hyderabad-based firm to 45 per cent. However, Ranbaxy had made it clear that it is not interested in taking over the company.
The Sensex ended up 244 points at 28,504 on strong global cues.
Dr Reddy's Laboratories has succeeded in developing a copycat or generic version of Pfizer's Lipitor, the world's largest selling drug which has sales of over $10 billion.
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.
Cipla tops pharma rankings with 5.42% market share, ahead of Ranbaxy and GSK.
Entering Iran may lead to trouble for those having significant presence in the US market.
The top gainers on the Sensex were Cipla, Bharti Airtel, Maruti Suzuki, Hero Moto & Sesa Sterlite.
Not far back, in 2010, SRL Diagnostics, promoted by former Ranbaxy promoters Malvinder and Shivinder Singh, acquired the diagnostic services business of Piramal Healthcare for Rs 600 crore (Rs 6 billion).
Combined net profit estimated to grow 14.6% year-on-year, against a 5.7% decline in the Dec 2015 quarter
Yusuf Hamied, Anji Reddy and Parvinder Singh are the real pioneers of the Indian pharmaceutical industry.
Companies such as Dr Reddy's Laboratories, Sun Pharmaceutical, Lupin and Ranbaxy striving to capitalise on opportunities created by pro-generic health care reforms in the US market are facing pricing pressure as the health care supply chain is undergoing consolidation.
Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
The 30-share Sensex ended down 224 points at 28,442 and the 50-share Nifty ended down 101 points at 8,606.
The 30-share Sensex ended down 604 points at 28,845 and the 50-share Nifty ended down 181 points at 8,757. The Bank Nifty ended down 602 points at 19,146.
Hamdard University (Jamia Hamdard) announces its admission notice to the PhD Pharmaceutical Medicine Programme.
Sensex, Nifty put up a good show in closing trade.
Dilip Shanghvi has never tried to be everything to everybody.
Sachin Bansal, who had co-founded Flipkart with Binny Bansal in 2007, would exit the company
As many as 15 companies across the world have lined up generic variants of Pfizer's Zoloft (Sertaline HCL), for which the exclusive six-month marketing period granted to the successful patent challenger, Teva of Israel, ends on Tuesday.
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