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Shengnuo suspends US peptide API shipments after FDA import alert

September 22, 2026 · TideMetrix Brief
TideMetrix TakeShengnuo’s US peptide API business has hit a regulatory roadblock. The company has suspended US shipments after its manufacturing subsidiary was placed on an FDA import alert.

Chengdu Shengnuo said in a September 22 announcement that it would suspend peptide API sales and shipments to the United States until its manufacturing subsidiary was removed from FDA Import Alert 66-40.

FDA’s list records the Chengdu Shengnuo Biopharm establishment at Xueshan Avenue in Dayi County from September 19. The alert permits detention without physical examination of covered products; it is separate from a shutdown of all company manufacturing.

The company reported eight Form 483 observations following an August inspection, covering matters including quality controls, contamination prevention and testing. It submitted an initial response on September 17. At the time of its announcement, Shengnuo said it had not received an official-action-indicated notification or a warning letter.

US revenue accounted for 32.83% of group revenue in the first half of 2026, according to the disclosure. That establishes the market’s commercial importance but does not quantify the peptide API volumes affected. No customer allocations or shipment-resumption date were disclosed.

The action concerns Chengdu Shengnuo and should not be confused with Jiangsu Sinopep-Allsino. It also does not establish a change in the capacity or construction status of Shengnuo’s separately disclosed GLP-1 manufacturing project.

Sources

Company announcement 2026-046, dated September 22

FDA Import Alert 66-40

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