Q: What production technology does Jiayi’s praziquantel use? Is it consistent with the impurity categories and indicators specified in the Pharmacopoeia?
A: Jiayi's mission is to become a global leader in praziquantel technology. Jiayi Praziquantel adopts Bayer technology, has specialized in the production of Praziquantel for 20 years, and has a strategic cooperation with Bayer! There are two types of global praziquantel production processes: Bayer technology and non-Bayer technology. Praziquantel was developed in the 1970s by Bayer, the originator of praziquantel. Bayer has had a profound impact on the prevention and control of schistosomiasis in the world, and has made great contributions to the prevention and treatment of schistosomiasis all over the world. The EP/USP Pharmacopoeia is formulated based on Bayer's production technology and has been used safely for more than 40 years. Bayer Technology's praziquantel confirms its quality standard in full compliance with the Pharmacopoeia. Non-Bayer technologies correspond to compendial impurity classes and specifications. Praziquantel that meets the quality standards of the Pharmacopoeia can ensure the safety of medication.
Q: Is Jiayi a GMP factory? Can customs clearance provide a certificate of free sale?
A: Jiayi is a GMP factory and can provide CERTIFICATE OF FREE SALE. In 2011, Jiayi obtained the GMP certification for praziquantel for the first time; in 2019, the new factory obtained the GMP certification for the first time; in 2022, it successfully passed the new version of GMP upgrade acceptance. Jiayi has complete qualifications, and has also obtained ISO9000/ISO14000/ISO45000 certification, with a complete quality system. It has accepted on-site audits by world-renowned companies such as Bayer, Sanofi, Boehringer Ingelheim, and ELANCO, successfully passed the acceptance inspection, and has strategic cooperation with Jiayi.
Q: What are the specifications and quality standards of Jiayi Praziquantel?
A: Jiayi praziquantel is divided into common powder and micropowder according to different particle sizes. Micropowder is mostly used in pets, aquatic products, tablets, liniments, water injections and other dosage forms, and common powder is mostly used in powders, premixes, etc. that require low precision. Preparation varieties. According to the quality standards, it is divided into European Pharmacopoeia EP/United States Pharmacopoeia USP/Chinese Veterinary Pharmacopoeia CVP.
Q: Does the elemental impurity of Jiayi’s praziquantel meet the requirements of ICH-Q3D?
A: Through the analysis and verification of raw materials and manufacturing equipment used by Jiayi Pharmaceutical, the elemental impurities of praziquantel API are controllable and meet the requirements of ICH-Q3D.
Q: Does the pollutant index of Jiayi’s praziquantel meet the requirements of the Pharmacopoeia?
A: Jiayi’s praziquantel adopts Bayer technology and has specialized in the production of praziquantel for 20 years. It has reliable technology and has a complete quality management system, environmental management system, safety and occupational health management system. The fine-baking package operation area is completed in a D-level clean area to ensure that the whole process of drug production is pollution-free, and the product pollutant indicators fully meet the quality requirements of the Pharmacopoeia.
Q: Does Jiayi’s praziquantel have BSE/TSE risks?
A: The production of Jiayi Pharmaceutical does not contain any animal-derived materials, and the products meet the requirements of the "Guidance Notes on Minimizing the Risk of Animal Spongiform Encephalopathy Drug Transmission Through Human and Veterinary Medicine". For this reason, Jia-praziquantel does not present any BSE/TSE risk.
