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US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

05-06-2014

European regulatory authorities have finalized their assessment of reported non-compliance with Good…

EuropeGenericsIndiaProductionRanbaxy LaboratoriesRegulation

UK’s MHRA seizes £8.6 million of counterfeit, controlled and unlicensed medicines

26-05-2014

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) revealed last week that it has seized…

ChinaIndiaMarkets & MarketingPharmaceuticalRegulationUK

Indian regulator seeks to address the nation’s substandard drugs problem

Indian regulator seeks to address the nation’s substandard drugs problem

22-04-2014

In what is something of an indictment of India’s pharmaceutical industry, the Drug Controller General…

Asia-PacificIndiaPharmaceuticalProductionRegulation

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

Ranbaxy recalls Lipitor generic over dose error

Ranbaxy recalls Lipitor generic over dose error

10-03-2014

India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles…

Atorvastatin CalciumCardio-vascularIndiaLipitorPharmaceuticalRanbaxy LaboratoriesRegulationUSA

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

FDA concludes Indian visit with pledge to focus on quality

FDA concludes Indian visit with pledge to focus on quality

18-02-2014

The US Food and Drug Administration’s visit to India concluded with roundtable meetings organized by…

IndiaPharmaceuticalRegulation

US FDA visit to India results in first Statement of Intent

US FDA visit to India results in first Statement of Intent

12-02-2014

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family…

IndiaPharmaceuticalPoliticsRegulationUSA

India raises concerns over FDA action during visit to promote collaboration

India raises concerns over FDA action during visit to promote collaboration

11-02-2014

The US Food and Drug Administration Commissioner Margaret Hamburg has met with India’s Commerce and…

IndiaPharmaceuticalRegulationUSA

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

Wockhardt drugs from Indian plant banned by US FDA

Wockhardt drugs from Indian plant banned by US FDA

28-11-2013

The US Food and Drug Administration has issued an import alert on medicines made by Indian drugmaker…

IndiaPharmaceuticalRegulationUSAWockhardt

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