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Hikma’s US facility back in compliance

Hikma’s US facility back in compliance

02-04-2014

Hikma Pharmaceuticals, Jordan's largest pharmaceutical company, has received a close-out letter from…

GenericsHikma PharmaceuticalsJordanPharmaceuticalRegulation

US FDA approves NDA from Actavis and Valeant

US FDA approves NDA from Actavis and Valeant

26-03-2014

US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration…

ActavisCanadaGenericsMetronidazolePharmaceuticalRegulationUSAValeant PharmaceuticalsWomen's Health

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

Canada's Health Minister sets out plan to help reduce impact of drug shortages

16-09-2013

A national protocol for the public notification of drug shortages and a toolkit that identifies steps…

GenericsHealthcareNorth AmericaPharmaceuticalRegulation

US FDA accepts Pennsaid 2% NDA for review

22-08-2013

The US Food and Drug Administration has accepted for filing US drugmaker Mallinckrodt's (NYSE: MNK) New…

Anti-Arthritics/RheumaticsGenericsMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Japan's MHLW approves 367 generics, but what does this mean?

21-08-2013

Japan's Ministry of Health Labor and Welfare (MHLW) approved 367 items of generic drugs last week. Launch…

Asia-PacificDiovanGenericsNovartisPharmaceuticalPricingRegulation

Proposed Bill for South Africa Health Products Regulatory Authority

15-08-2013

The South African Minister of Health has published the proposed amendments to the Medicines and Related…

GenericsPharmaceuticalRegulationRest of the World

New Zealand approves proposals diazepam, gabapentin and naltrexone listing

12-07-2013

New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval of proposals relating…

Asia-PacificdiazepamgabapentinGenericsnaltrexoneNeurologicalPharmaceuticalRegulation

Treatments for malaria, sleeping sickness and Chagas disease added to WHO's list of pediatric medicines

12-07-2013

The World Health Organization has released its updated Model List for Essential Medicines for Children…

artesunate-mefloquineBayerbenznidazoleCiplaGenericsGlobalNifurtimox-eflornithinePharmaceuticalRegulationSanofiTropical diseases

FDA plans to revise drug labeling regulations by September

05-07-2013

The US Food and Drug Administration says it plans to issue a proposed rule to revise FDA regulations…

GenericsNorth AmericaPharmaceuticalRegulation

Indian pharma threatened by trend of shifting R&D operations overseas: survey

04-07-2013

Red tape is putting India's multi-billion dollar worth pharmaceutical industry at risk, with most of…

Asia-PacificGenericsMarkets & MarketingPharmaceuticalRegulationResearch

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

June meeting highlights from EMA Pharmacovigilance Risk Assessment Committee

14-06-2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has made several recommendations…

codeinediclofenacEuropeflupirtineGenericshydroxyethyl-starchNeurologicalPharmaceuticalRegulation

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

Irish Medicines Board drawing up list of generic drugs to help reduce costs

10-06-2013

In Ireland, drugs to treat medical conditions such as high cholesterol, blood pressure and stomach ulcers…

EuropeFinancialGenericsHealthcarePharmaceuticalRegulation

Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst

05-06-2013

Later this month, following an inquiry launched in 2009, the European Commission is expected to impose…

EuropeFinancialGenericsNorth AmericaPatentsPharmaceuticalPoliticsRegulation

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

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 FDA to allow generic copies of Endo's Opana

13-05-2013

Endo Health Solutions (Nasdaq: ENDP) announced Friday (May 10) that the US Food and Drug Administration…

Endo Health SolutionsEndo PharmaceuticalsGenericsNeurologicalNorth AmericaOpana ERPharmaceuticalRegulation

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

US FDA warns pregnant women to not use valproate migraine prevention medicines

07-05-2013

The US Food and Drug Administration is alerting health care providers and patients that medications including…

Abbott LaboratoriesGenericsNeurologicalNorth AmericaNoven PharmaceuticalsPharmaceuticalRegulationSanofivalproate Sodium Injection

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