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STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems

STAT News

federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. After a decade of manufacturing problems, a U.S. However, the U.S. Continue to STAT+ to read the full story…

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Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says.

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Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

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Jailed pharma exec fined £47m and banned from industry

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The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits. Many people carry the illness but do not exhibit symptoms.

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Pharma’s climate change vulnerability and opportunity

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Water-borne illnesses are also likely to become more common, as increased rain and storm surges contribute to flooding and contaminated run off. In 2017, the global medicines supply was interrupted when Hurricane Maria hit Puerto Rico, home to more than 500 medical product facilities and producer of 10% of all drugs consumed in America.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The medications that we obtain in the U.S., and other high-income countries.