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Manufacturing

Set Alert for Manufacturing

Probable Carcinogen Found Haunting More Firms’ Valsartan API

As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.

Manufacturing Quality Recalls
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Latest From Manufacturing

China Regulatory Shakeup: Top Regulator Out, Commissioner Reprimanded Amid Vaccine Scandal

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

China Drug Safety

FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals

FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II. 

United States Manufacturing

The Quality Lowdown: A Week Of International Intrigue

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

Quality Manufacturing

Chinese API Maker Blasted For Failing To Document Equipment Cleaning And Lax Stability Testing Practices

FDA chastised Chinese API maker for inadequate cleaning validation, failing to ensure that products are manufactured in a state of control, and lax stability testing practices. The agency noted that the firm did not learn from observations the agency made of similar mistakes during previous inspections.

United States Manufacturing

FDA's Final Guideline Standardizes Dissolution Testing For Highly Soluble Drugs

FDA guidance aims to establish uniform dissolution testing methods for highly soluble immediate-release solid oral dosage forms.

Manufacturing Quality

FDA Says Shipping Logistics Should Be Priority For Cell Therapy Products

FDA says manufacturers need robust shipping programs to ensure the safety and quality of cell therapies, since there are no ready replacements and a patient’s life can be at risk if problems arise. Kite exec notes that “more than any other biologic, the supply chain of autologous cell therapies reaches really literally end-to-end.”

United States Manufacturing
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