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Hospira warned by FDA over Australian manufacturing facility

Hospira warned by FDA over Australian manufacturing facility

02-10-2014

USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and…

AustraliaGenericsHospiraProductionRegulationUSA

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

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

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

Joint generic drug inspections initiative announced by FDA and EMA

Joint generic drug inspections initiative announced by FDA and EMA

19-12-2013

In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed…

EuropeGenericsNorth AmericaProductionRegulation

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

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

17-09-2013

There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

US payers have more faith in biosimilars from multinationals

22-07-2013

US payer's trust in specific biosimilar manufacturers could dictate which companies will be most successful…

BiotechnologyEuropeGenericsNorth AmericaProductionRegulation

Grindeks gains new export opportunities in the USA

15-07-2013

Latvian drugmaker JSC Grindeks (GRD1R: RI ) says it has successfully passed a US Food and Drug Administration…

EuropeGenericsGrindeksNorth AmericaProductionRegulation

EU falsified medicines directive: imported active substances need written confirmation to guarantee GMP standards

03-07-2013

From July 2, 2013, all active substances manufactured outside of the European Union and imported into…

EuropeGenericsGlobalPharmaceuticalProductionRegulation

Waiver from European Commission to help exporting for US pharmaceutical manufacturers

24-06-2013

The US Food and Drug Administration announced on Friday (June 21) that the USA is now a "listed country"…

EuropeGenericsNorth AmericaPharmaceuticalProductionRegulation

China forms global alliance with Germany's blue inspection for drug quality

11-06-2013

Effective June 1, 2013, the China Chamber of Commerce for Import & Export of Medicines & Health Products…

Asia-PacificEuropeGenericsPharmaceuticalProductionRegulation

FDA warns Novartis on Austrian generic manufacturing plant cGMP failures

07-06-2013

The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major…

Ebewe PharmaGenericsNovartisProductionRegulationSandoz

CPhI Russia highlights growth in domestic manufacturing and international partnering

31-05-2013

Presentations at the CPhI Russia event which took place in April reflected growth in the Russian pharma…

EuropeGenericsPharmaceuticalProductionRegulation

Ranbaxy highlights its actions on improved business and quality assurance

23-05-2013

Indian drugmaker Ranbaxy Laboratories (BSE: 500359), whose US subsidiary was the subject of the biggest…

Daiichi SankyoGenericsManagementProductionRanbaxy LaboratoriesRegulation

Boehringer Ingelheim gets FDA warning letter on cGMP failures

22-05-2013

German family-owned drug major Boehringer Ingelheim today (May 22) revealed that the US Food and Drug…

Boehringer IngelheimGenericsPharmaceuticalProductionRegulation

US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements

14-05-2013

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

Canada strengthens drug safety with GMP now to apply to all APIs

09-05-2013

Canada's Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have…

GenericsNorth AmericaPharmaceuticalProductionRegulation

Argentina's pharma market to almost triple over one decade, says GlobalData

24-04-2013

Argentina's pharmaceutical market is expected to grow from a value of around $5.6 billion in 2012 to…

GenericsMarkets & MarketingPatentsPharmaceuticalProductionRegulationSouth America

Public Citizen slams FDA over lax oversight of "compounding pharmacies"

18-03-2013

Strengthened enforcement over compounding pharmacies that act as drug manufacturers would help alleviate…

GenericsNorth AmericaPharmaceuticalProductionRegulation

US federal judge approves consent decree with Boehringer's Ben Venue Labs

03-02-2013

The US Food and Drug Administration announced today that a federal judge has approved a consent decree…

Ben Venue LabsBoehringer IngelheimGenericsLegalPharmaceuticalProductionRegulation

US FDA details Generic Drug User Fee for APIs and finished dosage form facilities for FY2013

18-01-2013

In a federal Register posting, the US Food and Drug Administration has announced the rate for the generic…

FinancialGenericsNorth AmericaProductionRegulation

Ukrainian government threatens to impose ban on imports of foreign drugs

06-12-2012

The Ukrainian government is considering imposing a ban on the imports of up to 136 drugs to the country,…

EuropeGenericsMarkets & MarketingPharmaceuticalProductionRegulation

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