THE FDA HAS OFFICIALLY REMOVED ZHEJIANG HUAHAI PHARMACEUTICAL FROM IMPORT ALERT
Somerset, NJ, November 15, 2021 – Solco is pleased to announce that the FDA has lifted the Import
Alert (IA) 66-40, “Detention Without Physical Examination of Drugs From Firms Which Have Not Met
Drug GMPs”, Published Date: 11/12/2021, from Zhejiang Huahai Pharmaceutical Co. Ltd., at Coastal
Industrial Zone, Chuannan No. 1 Branch Site, Linhai, Zhejiang, China. Zhejiang Huahai Pharmaceutical
Co. Ltd is the parent company of Solco Healthcare US, LLC. Solco’s President Hai Wang expressed his
gratitude and congratulations to the entire Huahai team, “Congratulations and thank you to the Huahai
team for their hard work and dedication in making this happen. We look forward to reintroducing the
products affected by the Import Alert to the US market, as well as soon-to-be new product approvals.”
Mr. Wang further commented, “Solco has prepared a detailed return to market plan and associated
strategy that it now gets to implement. We will be reintroducing multiple products in a phased
approach, that allows Solco to meet its customer’s and patient’s needs. We are happy to resume
marketing these important products in the US and we will be working with our customers immediately.”
The removal of Zhejiang Huahai Pharmaceutical’s Chuannan site, a key API manufacturing plant, from
the Import Alert list, allows the company to restart production of all of the API made from this facilty.
This subsequently allows Huahai and Solco to reintroduce all of the products affected by the Import
Alert and opens the door for new approvals that utilized the facility’s API.
If you have any questions or would like additional information, please contact your Solco National
Account Manager or Solco’s Customer Service department at (855) 581-9688.