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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.
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Latest From Bowman Cox

The Quality Lowdown: The More Things Change …

US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.

Manufacturing Quality

Some Double Bar-Coding Required After November DSCSA Deadline, US FDA Says

As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.

Distribution Manufacturing

Contract Manufacturers Cautioned On Allure of Novel Cell and Gene Therapies

Contract development and manufacturing organizations are fielding requests from sponsors to ramp up for emerging novel treatment modalities like CAR-T cells and gene therapies but shouldn't "over-invest," consultant advises. Meanwhile, MAb production capacity, already huge, is growing 50% over the next five years to meet surging demand.

Business Strategies Manufacturing

The Quality Lowdown: A Contagion Of Dubious Sterility Assurance?

The constant battle of assuring the sterility of purportedly sterile products is underscored by recent warning letters, consumer alerts and other notices from US FDA. It’s clear at least that some firms are serious about microbial contamination risks – others, not so much.

Compliance Manufacturing

Another Nitrosamine Impurity Found In Valsartan; ‘Low’ Cancer Risk Seen

Zhejiang Huahai has detected a second probable carcinogen in valsartan API it manufactured. Meanwhile risk analysis suggests cancer risk from the first probable carcinogen is low, at least so far.

Manufacturing Quality

The Quality Lowdown: Risk And Opportunity

Recent developments confirm the laser focus of the US FDA and the pharmaceutical industry on managing quality risks such as potentially carcinogenic impurities, product mix-ups and microbial contamination. But they also underscored opportunities like global regulatory harmonization, assay development and responses to negative pre-approval inspections.

Quality Compliance
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