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Top Headlines

Xellia starts work on testing lab at Hungary API plant citing growing demand

Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.

CGT to test scaffold tech for commercial-scale T-cell production

The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.

Mock sheets and lack of stability data: US FDA hits two API makers with warnings

The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.

Drugs tracked in Ongar: Selcia opens radiolabelled API plant

Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.

Croatia's Halmed finds GMP deficiencies at Dhanuka Labs' antibiotic API plant

An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.

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