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FDA slaps Indian API maker in warning letterIn a warning letter, the FDA showedits dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness. Theletterwas issued to Resonance Laborator2017/3/1
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China facility of Ausmetics hit with FDA warning letterThe FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with“significant violations” of cGMP regulations saying that it did not do enough to test its active in2017/3/1
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Another Japanese drugmaker cited in FDA warning letterFor the third time in recent months, the FDA has slammed a Japanese drugcompany in a warning letter, this timefor not doing enough to prevent contamination during aseptic filling. The most recent FD2017/2/28
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Italian sterile drugmaker Facta Farmaceutici slammed in FDA warning letterThe FDA has caught an Italian drugmaker apparently manipulating testing dataas it reported only passing tests even though original reports indicated out-of-specification results for things like partic2017/2/28
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FDA and EMA both hammer Brazilian sterile antibiotics maker over contamination concernsA Brazilian antibiotics maker that was hammered in an FDA warning letter issued last month also caught the attention of the European Medicines Agency, which has banned its products because of concerns2017/2/27
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FDA warning savages Porton for contamination that led to shortage of Jazz Pharma leukemia drugThe FDA has savaged U.K.-based Porton Biopharma (PBL) in a warningletterfor repeated contamination of batches of Erwinaze, a blood cancer drug for children that it manufactures for Jazz Pharmaceutical2017/2/27
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FDA delivers Form 483 to Eisai plant in U.S.Japan’s Eisai, which has reduced its manufacturing operations in the U.S., is now facing regulatory concerns for a plant in Baltimore, Maryland. The facility has received an FDA Form 483 with 5 obser2017/2/24
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Liquid biopsies in melanoma – transformation of patient care tantalizingly closeAn innovative blood test is now being used in Melbourne, Australia, which allows the diagnosis of melanoma sooner and gives patients the best chance of survival. In November 2016, the Olivia Newton-Jo2017/2/23
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US FDA grants fast-track designation to Cell Medica's CMD-003The US Food and Drug Administration (FDA) has granted fast-track designation to UK-based cellular immunotherapy firm Cell Medica's oncology product CMD-003 (baltaleucel-T). The designation includes t2017/2/23
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Recipharm acquires Kemwell’s pharmaceutical businesses in India for $118.5mSweden's Recipharm has completed the previously announced acquisition of Kemwell’s pharmaceutical businesses in Bengaluru, India, in a deal valued at Skr1.05bn ($118.5m). The acquisition was initiall2017/2/22