solchickio|科兴制药:通过欧盟GMP认证

editor Current 2024-05-05 5 0

Newsletter summary

Sinopec Pharmaceuticals: through the EU GMP certification Securities Times e News, Sinopec Pharmaceuticals announced on the evening of May 5, recently received the Norwegian Drug Administration in accordance with the relevant regulations of the European Drug Administration issuedSolchickioGMP Certificate of drugs, certified products: paclitaxel for injection (albumin-bound) (5mg/mSolchickio...

solchickio|科兴制药:通过欧盟GMP认证

Text of news flash

Kexing Pharmaceuticals: through the EU GMP certification Securities Times e news, Sinopec Pharmaceutical announced on the evening of May 5, recently received the Norwegian Drug Administration in accordance with the relevant regulations of the European Drug Administration issued the "Drug GMP Certificate", certified products: paclitaxel for injection (albumin binding) (5mg/ml). Paclitaxel for injection (albumin-bound) is the mainstream first-line drug recommended by the European Society of Medical Oncology guidelines for the treatment of metastatic pancreatic cancer and non-small cell lung cancer. According to the GMP mutual recognition system among EU member states, the GMP certification shows that the certified production line has met the EU GMP standards, and the company's paclitaxel (albumin-bound) products have EU market access qualifications. After passing the GMP certification, paclitaxel for injection (albumin-bound) still needs to be approved by the EU listing license Application (MAA) before it can be listed in the EU.