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Intas becomes first Indian company to launch biosimilar in the EU

Intas becomes first Indian company to launch biosimilar in the EU

23-02-2015

Indian biopharma company Intas has become the first Indian company to launch a biosimilar in highly regulated…

BiosimilarsBiotechnologyFilgrastimHematologyImmunologicalsIndiaIntas PharmaceuticalsMarkets & MarketingRegulation

Tecfidera, first-line oral treatment for multiple sclerosis, approved in India

13-02-2015

US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for…

Biogen IdecBiotechnologyIndiaNeurologicalRegulationTecfidera

US FDA issues another warning letter over failures at Apotex’ Indian plant

US FDA issues another warning letter over failures at Apotex’ Indian plant

09-02-2015

The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics…

ApotexApotex Research Private LimitedGenericsIndiaProductionRegulationUSA

EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

Health Canada instigates quarantine of products from Sri Krishna Pharmaceuticals

Health Canada instigates quarantine of products from Sri Krishna Pharmaceuticals

07-01-2015

At Health Canada's request, Canadian importers have agreed to quarantine health products made with active…

CanadaGenericsIndiaItalyRegulationSri Krishna Pharmaceuticals

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

15-12-2014

The National Pharmaceutical Pricing Authority (NPPA) of India has issued a notice capping prices of 52…

BaxterGlaxoSmithKlineIndiaPharmaceuticalPricingRegulationWockhardt

EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

06-12-2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

India takes action on spurious and sub-standard drugs

India takes action on spurious and sub-standard drugs

10-11-2014

An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals…

GenericsIndiaMarkets & MarketingPharmaceuticalPoliticsRegulation

Health Canada issues import ban from three Indian drug plants

Health Canada issues import ban from three Indian drug plants

01-10-2014

Regulator Health Canada has taken action to stop the imports from three Indian manufacturing sites.

Apotex Research Private LimitedCanadaIndiaIpca LaboratoriesPharmaceuticalRegulation

Indian government takes action over dubious fixed-dose combinations

Indian government takes action over dubious fixed-dose combinations

30-09-2014

In a bid to weed out potentially unsafe combinations, the Central Drugs Standards and Control Organization…

Cadila PharmaGenericsIndiaPricingRegulation

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

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

1 to 25 of 31 results

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