1. Natural Paclitaxel Manufacture Line: Ø Entered the sixth month of accelerated stability test (three validation batches: 800~1000 g/batch). Hande method validation of metal elements is in progress. Estimated it would be finished in Oct.
Ø The fourth batch, commercial batch (93 gram), is produced on 5-Aug, which finished test on 19-Aug. It would be supplied for research or producing of validation batches and etc.
2. Regulation Submission:
Ø DMF for China: compilation is completed. Submitting to CDE in this month.
Ø After Nov., new supplier for original material produced validation batches, starting the supplement of document for EDQM AND DMF (FDA). Expect report the data of stability test of one month in Dec.
Ø Preparing the record in Russia, Turkey and other emerging market.
Ø In Aug., both two rounds of GMP compliance inspections made by SGS (third-party organization) was completed. Presently, audit corrective action report is reported. The Certificate of GMP Conformity is to be approved in the late of Sept.
3. Initial Processing Line:
Ø In order to improve the capacity, some part of process is improved. Now the three validation batches of developed process are finished. Except the need of producing natural paclitaxel, 50~60 kg 10-DAB III (assay: 99%) is able to be provided from Nov. on.
Ø 10-DAB III DMF submitting time expected in the end of Oct. Complete reporting is ended in the late of 2019.
Through the site-audit and sample test for several Yew plantation bases from July to August, the procurement plan of 2019-2020 has been implemented with three large-scale planting bases to ensure sufficient raw material supply of effective amount of paclitaxel.