German drugmaker Fresenius Kabi punished a U.S. wholesaler this year after it mistakenly sold its anesthetic propofol to the state of Missouri, which intended to use it for executions. Missouri has agreed to return the drug after the Louisiana-based firm pleaded to authorities.
Just weeks after the FDA savaged a cancer drug plant in India for lying to investigators and hiding test results, it has received yet another warning letter, this time for problems at a Puerto Rico blood bag manufacturing facility.
An FDA warning letter to Indian drugmaker Posh Chemicals says that a quality-control chemist admitted during a March inspection that he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager.
The generics division of the German healthcare company has bought controlling interest in Indonesian drugmaker PT Ethica Industri Farmasi from PT Soho Global Healthcare. The two will build a $60 million plant to make IV generic drugs and infusion solutions and make Fresenius Kabi the market leader in IV generics in Indonesia.
Germany's Fresenius Kabi has decided to expand into Southeast Asia with a plant in Indonesia to make intravenous drugs, buying controlling interest in Indonesian drugmaker PT Ethica Industri Farmasi from PT Soho Global Healthcare.
Sources tell The Wall Street Journal that the deal could be worth $200 million.
India's Intellectual Property Appellate Board (IPAB) has pulled the patent that GlaxoSmithKline had for its breast cancer drug Tykerb, a salt form of lapatinib, while upholding the patent on the original API.
Fresenius Kabi is taking seriously the FDA's allegations that staff at an Indian API plant lied to investigators and concealed data, and the generic drug unit of the German healthcare giant said it has fired the workers responsible.
Its announcement said the FDA had found problems in manufacturing quality, but its description did not come close to indicating the depth of the problems the FDA found there.
Fresenius Kabi, the generic drug unit for the German healthcare company, has received its second FDA warning letter n 18 months, this time for a plant in India. And it has had two recent recalls because of glass particles found in vials of injectable drugs.