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Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

Indian drugmakers readying for next “Patent cliff”

24-02-2014

The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest…

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

10-02-2014

Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

Regulatory update on Indian clinical research approval timelines

04-02-2014

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry…

Asia-PacificIndiaPharmaceuticalRegulationResearch

India loses its attraction for pharma clinical trials, as domestic regulations tighten

India loses its attraction for pharma clinical trials, as domestic regulations tighten

27-01-2014

Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with…

Asia-PacificBioconIndiaPharmaceuticalPiramal HealthcareRegulationResearch

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

09-01-2014

Due to its large population and substantial unmet medical needs, India represents a market with strong…

Asia-PacificIndiaMarkets & MarketingPharmaceuticalPricingRegulation

Russia, Ukraine and the Baltic states increasing in importance on the contract manufacturing market

Russia, Ukraine and the Baltic states increasing in importance on the contract manufacturing market

11-12-2013

Russia seems to be an attractive country for pharmaceutical contract manufacturing, chiefly because of…

Asia-PacificChinaEastern EuropeGenericsIndiaProductionRegulationRussiaUkraine

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