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Wockhardt target for fresh FDA concerns over US unit

Wockhardt target for fresh FDA concerns over US unit

28-05-2014

Indian drugmaker Wockhardt is facing fresh concerns from the US Food and Drug Administration over processes…

Clinical researchHealth Medical PharmaIndiaManaging directorPharmaceuticalPharmaceutical sciencesProductionRegulationUnited StatesUSAWockhardt

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

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

India and the USA need to collaborate

India and the USA need to collaborate

14-02-2014

Here's our take on the week's top stories.

IndiaPharmaceuticalRanbaxy LaboratoriesRegulationUSAWockhardt

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

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

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

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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