Indian pharma firms under European drug regulator's scanner.
US markets have been very lucrative for the Indian pharma companies and many companies such as Ranbaxy and Dr Reddy's capitalised on this opportunity.
Sun Pharma's Dilip Shanghvi is India's richest person.
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.
Launches cloud-based version of solution to target mid-size clients in life sciences.
IT, pharma and FMCG stocks are the top performers in 2013.
Ties between India and the United States have been strained in recent years because of trade policies and patent disputes.
The challenge of merging Ranbaxy into the company has not been factored in.
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.
A global policy would reward firms which strive for higher quality.
This is to take head on big American pharmaceutical giants, which in the recent past had launched a strong anti-India campaign against efforts of such companies to provide affordable health care not only to people in India, but also in the third world countries.
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.
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.
Face NPPA fine for overcharging on anti-asthma drug
The Singapore subsidiary of the UK-based GlaxoSmithKline plans to buy 24.33 per cent stake or 2.06 crore equity shares in GlaxoSmithKline Pharmaceuticals Ltd through an open offer.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
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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.
Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
Sun Pharma profit down 30% over compliance costs, lower sales.
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
The big companies too are responsible for the sub-standard drugs in the market.
Benchmark indices finished higher on hopes of economic reforms
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.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
FDI in brownfield investment has resulted in acquisition of domestic drug-manufacturing firms by multinational companies.
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
Top companies added employees at 3% CAGR from 2003-04 to 2013-14, while revenues grew at 18%.
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.
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