Global R&D Center
In 2016, Kingfriend's R&D Center passed the U.S. FDA inspection, becoming one of the first sterile formulation R&D organizations in China to achieve this distinction. Over the years, we have steadily advanced our capabilities and continued to expand the technical boundaries of formulation development.
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NKF
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Kindos
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Meitheal
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Evumed
Formulation R&D Platform
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R&D & Complex Formulations
Kingfriend’s FDA zero‑483 R&D center offers full formulation services for biologics, high‑end generics, 505(b)(2), and small molecule innovator drugs. We have proven expertise in high‑barrier drugs (light, oxygen, or temperature‑sensitive, potent, non‑aqueous, poorly soluble or easily hydrolyzable) and novel delivery systems (emulsions, micelles, liposomes, nanoparticles, LNP).
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Aseptic Manufacturing & Scale‑Up
Kingfriend was the first in China to introduce OEB 5 fully enclosed aseptic barrier isolators for dispensing, formulation, filling, and sterility testing. We use disposable filling systems to achieve complete physical isolation between operators and sterile drugs. Our fully automated production and online monitoring include CIP/SIP, in‑process weighing, environmental monitoring, automated lyo loading/unloading, and automated inspection & packaging. Advanced processes include low‑temperature/low‑oxygen filling and non‑aqueous lyophilization. We offer flexible scale‑up with vial sizes 2–100 mL, lyo capacity 0.5–40 m², and formulation capacity 10–2500 L.
