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

European Pharmaceutical Review

Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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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. Nitisinone capsules are hydroxy-phenylpyruvate dioxygenase inhibitors which are used as first-line treatment for a rare condition, hereditary tyrosinemia type 1 (HT-1).

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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.” Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

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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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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review. The draft ICH M10 guideline was published for comments in 2019.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

In turn, this impedes growth of the market because of the resulting delay in product approvals. 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.

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Harrow agrees to acquire US rights to Novartis’ ophthalmic products

Pharmaceutical Technology

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).