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Production & Manufacturing

Natco Pharma wins license to manufacture, sell Nexavar in India

The Indian patents office has awarded a license to Natco Pharma to manufacture and sell a generic version of Bayer's cancer treatment drug Nexavar. As per the Indian Patents Act, Natco Pharma will be...

BioLife Solutions to build second GMP production facility

BioLife Solutions has executed an amendment to its current commercial lease to double the area of its existing facilities. The additional space will be used to the build a second GMP manufacturing clean room...

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...

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...

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...

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...

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...

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