Production & Manufacturing
Production & Manufacturing
Eurogentec drug substance manufacturing facility wins FDA nod
The FDA has granted acceptable status, under its current regulatory guidelines, to Eurogentec's Seraing, Belgium drug substance manufacturing facility. The status will allow Eurogentec to manufacture a commercial bulk parenteral biopharmaceutical for one of its...
Production & Manufacturing
Dainippon wins manufacturing approval for sleep inducing therapy in Japan
Dainippon Sumitomo Pharma has obtained manufacturing and marketing approval for Zolpidem tartrate tablets 5mg/10mg from the Ministry of Health, Labour and Welfare in Japan. Zolpidem tartrate tablets 5mg/10mg are film-coated tablets containing 5mg...
Production & Manufacturing
EMA approves Genzyme Framingham manufacturing plant
The European Medicines Agency (EMA) has approved Genzyme’s manufacturing plant in Framingham, Massachusetts, US for the production of Fabrazyme (agalsidase beta). Fabrazyme (agalsidase beta) is used to treat patients with Fabry disease. Fabrazyme lowers...
Production & Manufacturing
Islet Sciences chooses NeoStem unit for product manufacturing
Progenitor Cell Therapy (PCT), a unit of NeoStem's cell therapy manufacturing, has entered an agreement to provide contract manufacturing and regulatory services related to the development of Islet Sciences' PTM. PTM is an injectable...
Production & Manufacturing
Bayer joins Russian firm to manufacture drugs
German pharmaceutical company Bayer and Yunona Holdings, representing the Ural Pharmaceutical Cluster (UPC) of Russia have entered a memorandum of understanding to manufacture drugs in Russia. The companies intend to establish themselves in the fields of...
Production & Manufacturing
AstraZeneca invests $200m to set up manufacturing facility in China
AstraZeneca has invested $200m in a new manufacturing facility in China Medical City, Taizhou, Jiangsu province. The new plant will manufacture both intravenous and oral solid medicines.According to the company, the new plant will help meet the rising demand...
Production & Manufacturing
CMC Biologics, Inspiration team up to manufacture hemophilia B drug
Denmark based CMC Biologics and US based Inspiration Biopharmaceuticals have signed a supply agreement to manufacturing bulk IB1001 as a treatment and preventive measure of bleeding in individuals with hemophilia B. The agreement allows...
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