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FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

16-06-2014

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

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

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

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

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

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

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

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Russia to postpone transfer of domestic pharma production to GMP-standards until 2016

21-02-2014

The Russian government has decided to postpone until 2016 the requirement of domestic pharmaceutical…

Eastern EuropePharmaceuticalProductionRegulationRussia

NW Bio to expand manufacturing of DCVax products

27-01-2014

US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

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

Russian government continues to create barriers for foreign pharma business

Russian government continues to create barriers for foreign pharma business

23-12-2013

The Russian government continues to create barriers for the business of foreign pharmaceutical producers…

Eastern EuropePharmaceuticalProductionRegulationRussia

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

UK’s medicines watchdog recalls five Wockhardt medicines

UK’s medicines watchdog recalls five Wockhardt medicines

18-10-2013

The UK’s Medicines and Healthcare products Regulatory Agency has recalled five medicines made by Indian…

AnalgesiaDiabetesEuropeGliclazidePharmaceuticalProductionRegulationWockhardt

FDA clears Eisai Zonegran facility in UK for US exports

FDA clears Eisai Zonegran facility in UK for US exports

15-10-2013

Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran…

EisaiEuropeNeurologicalNorth AmericaPharmaceuticalProductionRegulationZonegran

Wockhardt hit hard by MHRA’s withdrawal of certificate

Wockhardt hit hard by MHRA’s withdrawal of certificate

15-10-2013

Indian drugmaker Wockhardt has had its Good Manufacturing Practice certificate revoked by the UK’s…

Asia-PacificPharmaceuticalProductionRegulationWockhardt

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

Biological E's Japanese Encephalitis vaccine prequalified by WHO

23-07-2013

Indian biopharmaceutical company Biological E (BioE) and European biotech company Valneva (Euronext:…

Biological E LtdBiotechnologyProductionRegulationVaccinesValneva

Kiadis to receive GMP manufacturing license and certificate

23-07-2013

Netherlands-based, privately-held clinical stage biopharma company Kiadis Pharma said today (July 24)…

ATIRBiotechnologyEuropeKiadis PharmaProductionRegulation

Venus gets GMP certifications from Ukraine

22-07-2013

Indian R&D-based drugmaker Venus Remedies (BSE: 526953) has been able to gain a Good Manufacturing Practice…

Antibiotics and Infectious diseasesAsia-PacificEuropeMarkets & MarketingOncologyPharmaceuticalProductionRegulationVenus Remedies

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

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