News 2020-04-21
Porton Successfully Receives Third US FDA Inspection.
We are proud to announce that Porton’s cGMP-compliant Erlang site located in the Chonqing Metro Region, China passed a 4-day general inspection [April 24-28, 2016] by the US FDA without any Form 483 observations. This is the third successful inspection of our China sites by the US FDA since 2013. Supported by a unified Quality Management System and Corporate Quality Group, Porton’s production sites continue to reliably deliver efficient and high-quality manufacturing solutions across the full life cycle for our valued global customers. Learn how we can help you – contact us today!
Note: Porton is still waiting for FDA’s official written document “EIR” (Establishment Investigation Report) of this Erlang inspection, more information shall be disclosed in compliance with China listed-company disclosure rules accordingly.
Note: Porton is still waiting for FDA’s official written document “EIR” (Establishment Investigation Report) of this Erlang inspection, more information shall be disclosed in compliance with China listed-company disclosure rules accordingly.
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News 2026-07-08
Porton Advanced’s UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance
Porton Advanced’s UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance
News 2026-07-03
Porton Delivers Dual-Payload ADC IND, Advancing Next-generation Conjugate Drug Development
Porton One-stop Biologics and Conjugates CDMO Platform successfully completed the full-cycle delivery of process development and GMP IND clinical sample manufacturing for a dual-payload ADC.
