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USFDA chief supports generics made in IndiaThe Indian drug makers are finally seeing a recovery with most of their factories being cleared by the US watchdog.- US may dilute norm used to delay genericsThe move, if successful, is expected to help Indian companies gain easier access to the world’s biggest pharma market.
- Beaten-down pharma stocks hope for boost from new USFDA chiefScott Gottlieb is known to favour quicker entry of generic drugs in the market.
- The new USFDA commissioner actually knows his job: Amit Rajan, Director, Celogen Life SciencesData integrity per se will not be an issue for big Indian pharma companies: Amit Rajan, Director, Celogen Life Sciences.
- Gujarat shares Maggi sample testing method with USFDAThe decision was taken after the test reports showed that lead was present above the prescribed limit and also showed the presence of monos...
- Indian companies not singled out for inspections, says USFDAUSFDA said it is looking to increase training and joint inspections in various areas, including manufacturing while also discussing possibi...
- USFDA officials to visit India this month; to sign pactHigh-ranking officials of US health regulator USFDA will be travelling to India later this month to meet their senior regulatory counterpar...
- US based Underwriters Laboratories inks pact with Gujarat government to train FDCA inspectorsThe company has signed a memorandum of understanding (MoU) with the Gujarat government to train Gujarat Food and Drug Control Authority (FD...
- State drug regulators tap USFDA coach to polish skills on good manufacturingUL claims to have trained over 36,000 USFDA investigators over the past two-three decades 'in an exclusive partnership'.
- USFDA issues warning to Indian drug maker Marck BiosciencesMarck Biosciences, now known as Amanta Healthcare received warning letter by US drug authority. USFDA found flase data and dead & decaying ...
- Indian Pharma: Regaining our brand equityThe perception that India-made drugs are of “bad quality” is largely due to many related and unrelated convergence of events.
- India ready to discuss intellectual property rights norms at WTO if US wants: Anand SharmaRejecting US allegations related to intellectual property rights, India said that it is ready to discuss the matter at WTO as it has not br...
- India pitches for review of US pharma whistle blower policyTaking up the case of domestic pharma sector with the US, India has pitched for review of America's whistle blower policy and lowering of r...
- How FDA's decision to put Ranbaxy's Toansa unit under import alert can hurt growth of Indian pharmaWith almost 40 per cent of generic drugs dispensed in the US coming from India, the USFDA has to look at Indian pharma more closely.
- Ranbaxy slips as USFDA refuses request to allow exports from banned unitsThe USFDA prohibited Ranbaxy Labs from manufacturing and distributing APIs from its Toansa plant for FDA-regulated drug products.
- USFDA to hold workshops across India on quality requirementsUSFDA plans to conduct workshops across India in the next one year in order to sanitise Indian drug cos about the changing quality requirem...
- Affordable drugs don't mean spurious: Ghulam Nabi Azad tells USGhulam Nabi Azad did some plainspeak with the head of US drug regulator, asserting that Indian drugs should not be treated as spurious.
- India raises concerns over FDA actions on domestic drug firmsThe matter came up during a meeting here between Commerce and Industry Minister Anand Sharma and USFDA Commissioner Margaret A Hamburg.
- 30 Indian basmati rice samples contain arsenic: USFDAThe US Food and Drug Administration has found arsenic content in about 30 samples ofIndian basmati rice in its preliminary analysis.
- Sun Pharma to export generic version of cancer medicine Lipidox to USShares of Sun Pharma rose 4% on Wednesday after the US drug regulator said it will import generic version of the cancer drug Lipidox.
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