Tag: GMP Standards

FDA Warned Deva Holding over GMP Violations at the Tekirdağ Manufacturing Site

The US Food and Drug Administration (FDA) warned Turkish drugmaker Deva Holding AS earlier this month over good manufacturing practice (GMP) violations at the company’s Tekirdağ manufacturing site. ...

FDA Described GMP Deficiencies at Topical Products Manufacturer

GMP
The FDA has recently issued a Warning Letter describing serious GMP deficiencies to a US manufacturer of over-the-counter (OTC) topical products. The deficiencies concerned, among others, the water sy...

PPD boosts its GMP lab testing scope

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PPD is adding gene and cell therapy analytical testing to its GMP laboratory in Athlone (Ireland), to support the pharmaceutical industry’s growing need for biologics testing.

SID&GP to held a workshop on GMP requirements for API manufacturing

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On 20-21 December, the State Institute of Drugs and Good Practices (FSI "SID&GP") jointly with Pharmstrategy Ltd. will held an open expert-advisory workshop "Requirements and Application of GMP Ru...

Rentschler Fill Solutions launched a fill and finish facility in Austria

pharma vial
Rentschler Fill Solutions GmbH, a contract development and manufacturing organization and expert in aseptic fill and finish services, officially inaugurated its new facility in Rankweil (Austria).

VGXI boosts its RNA and DNA therapeutics manufacturing capabilities

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VGXI announced the opening of a facility expansion which includes flexible scale plasmid DNA manufacturing space as well as purpose-built GMP production areas for RNA synthesis.

Russian blister foil is produced in accordance with GMP

Everything about GMP compliant blister foil  at Pharmtech & Ingredients at the stand of a major Russian producer - the Packaging Factory MILK. The high quality primary packaging will be represente...

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

lonza building
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

biologics
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.