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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

Safety 70
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Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation

European Pharmaceutical Review

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al.

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Juno Pharmaceuticals buys Omega Laboratories

Pharmaceutical Technology

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.