Tag: GMP Standards

Axim Biotechnologies receives Dutch GMP for cannabinoid medicines production

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AXIM Biotechnologies announced that it has received a manufacturing license from the Dutch Ministry of Health, Welfare and Sports for the production of the company’s pharmaceutical products.

Idifarma announced renewal of its EU-GMP certificate

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Idifarma, a Spanish contract development and manufacturing organisation (CDMO), announced the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its EU GMP plant.

NatiVita aims to reach the Syrian and Iraqi markets

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Belarus' pharmaceutical company NatiVita (Vitebsk Oblast) intends to branch out into the Syrian and Iraqi markets in 2019-2020.

SID&GP and PHARMSTRATEGY held a workshop on validation of computerized systems

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A joint educational project organized by the SID&GP of the Russian Ministry of Industry and Trade and PHARMSTRATEGY is aimed to promote the best practices in the Russian pharma industry.

Russia cements its friendly relations with Saudi Arabia

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The Saudi Food and Drug Authority opened its annual conference in Riyadh. The Saudi Arabian pharmaceutical market is the largest in the Middle East and North Africa.

WuXi Biologics became an exclusive GMP manufacturing partner for Inhibrx

wuxi-biologics
WuXi Biologics and Inhibrx announced that the companies have entered into an exclusive partnership for the GMP manufacturing of certain of Inhibrx’s protein-based therapeutics.

Lonza initiated a pharmaceutical early-intermediates supply initiative

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The initiative leverages chemical production facilities at the company’s Visp (Switzerland) site to address increasing global early-intermediates supply security and quality concerns.

Pall Biotech to collaborate with Aetos Biologics

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Pall Corporation has announced a strategic partnership between its Pall Biotech business unit and Aetos Biologics, a biosimilar cell line development company.

Kaneka begins a continuous GMP manufacturing

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Kaneka Corporation have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore with commercial production under cGMP already underway.

Almac launches GMP peptide manufacturing facility in Scotland

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Almac Group, the global contract development and manufacturing organisation, is delighted to announce the successful MHRA registration of its High Throughput GMP Peptide manufacturing facility.

WuXi Biologics successfully completed the first run of its MFG3 facility

wuxi-biologics
WuXi Biologics, a leading global open-access biologics technology platform company, announced that the first GMP campaign in the new MFG3 facility was completed successfully.

Russia and Bulgaria signed cooperation agreement

Shestakov and Stoimenova
Last week in Sofia Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices, Deputy Head of the State GMP Inspectorate met with Assena Stoimenova, Executive Director of the Bulgarian Drug Agency.

CellGenix expands its German facility

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CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion.

Russia amended procedure for state registration of some medicinal products

pharma manufacturing
The following amendments are introduced to the Russian Federal Law “On Circulation of Medicines" with regard to the state registration of medicinal products.

Samsung Biologics biggest plant received FDA approval

samsung biologics
Samsung BioLogics announced that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world’s largest single plant.

EMA withdraws the license from Taiwan’s pharma company

european medicines agency
The European Medicines Agency (EMA) is withdrawing the license of Taiwan-based Savior Liftec after the discovery of serious Good Manufacturing Practice (GMP) non-compliance after an inspection conducted earlier this month.