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Ingredients: Top Headlines

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

Xellia API plant in Budapest (source Xellia)

26-May-2016 - 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.

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News in brief

Drugs tracked in Ongar: Selcia opens radiolabelled API plant

25-May-2016 - 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.

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

25-May-2016 - 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.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating product line in a deal announced today.

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

25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.

Olon SpA to buy Infa Group

23-May-2016 - Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.

IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code

23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).

Italian regulator slams simvastatin-maker Krebs for GMP deviations

23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.

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