We , a rare independent manufacturer of paclitaxel API in the whole world.
We, from 1993 to now, a company with more than twenty-year experiences still full of vigor.
We, honored by US FDA, EDQM and CFDA, continue to work hard.
We, a talented team, enhance our quality system with the combination of wisdom and experience.
We, born to perfect, work to achieve high quality.
Established quality system and performed as per GMP.
Filed first DMF to U.S.FDA for natural Paclitaxel (#11909).
Passed U.S.FDA’s inspection for the first time. Passed CFDA’s GMP inspection and obtained GMP Certificate; Passed U.S.FDA’s cGMP inspection.
Passed GMP Inspection performed by CFDA;
Filed DMF to U.S.FDA for semi-synthetic Paclitaxel (#22839);
Obtained CEP for natural Paclitaxel.
Accepted U.S.FDA’s inspection.
Obtained CEP for semi-synthetic Paclitaxel.
GMP Certificate issued by TGA；Passed U.S.FDA’s inspection.
Passed CFDA’s GMP inspection and obtained GMP Certificate.
Filed DMF to PMDA for natural Paclitaxel (#227MF10193).
Registration to IFDA for natural Paclitaxel (Form 41) in October.