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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

Zydus Cadila’s New Injectables Plant Could Help Blunt US Drug Shortages

Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.

Manufacturing Quality

Cadila Shifts US Injectables Production From Plant After Tough FDA Inspection

Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.

Enforcement Manufacturing

Mylan Warning Letter Exposes Challenges In Valsartan Supply Chain Chemistry

Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’

Manufacturing Quality

FDA Finds Ranitidine Poses Little Risk, But Concerns Linger

Ranitidine no more carcinogenic than grilled meat, says FDA drug center director Janet Woodcock. Agency finds NDMA levels in ranitidine drugs well below those claimed by Valisure, online pharmacy asking FDA to order drug off US market.

US FDA Finds Zantac Poses Little Risk, But Concerns Linger

Ranitidine no more carcinogenic than grilled meat, the FDA’s Woodcock says, with NDMA levels well below those claimed by Valisure.

Manufacturing Quality

Real-Time Manufacturing Volume Reporting Could Help Prevent Drug Shortages, Woodcock Tells Congress

If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.

Quality Manufacturing
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