- Kako velik proizvajalec so, velik

- Kako velik proizvajalec so, velikost serije, velikost proizvodnje v 2014 in 2015
- V prilogi TDPji ki smo jih dobili v 2014. Preverita ali delajo po teh RoSih, rabimo detajlne RoSe od aktualnih štartnih materialov.
- Če slučajno kakšen del procesa outsourcajo, naj to razložijo.
- Za aktualne ključne ŠM preverita odobrene vire
- Ali je proces zvalidiran, od katere stopnje naprej?
- Kakšen je GMP nivo, ob predpostavki če bi v prihodnosti bila regulatorno intermediata?
- Kakšen je nivo analitike, katere nečistote spremljajo? To sprašujem, ker mi trenutno spreminjamo specifikacije in metode..
- Komu prodajajo, jih je kdo presojal?
- Cena za 2 tone in 5 ton letno


So tudi registriran vir v našem CEPu za pantoprazol za oba RSMja: panto kloro in 5-FMBI. Ali so aktualni proizvajalci, če ja, prosim za status, info podobne kot zgoraj.

結果 (英文) 2:

- How big are the manufacturer, batch size, the size of the production in 2014 and 2015
- In an annex TDPji we got in 2014. Check or working under these RoSih, we need detailed Rose from the current starting materials.
- If you happen to any part of the process outsourcajo to to explain.
- For current key WF review the approved resources
- Is the process validated, from which rates continue?
- What is GMP level, assuming if in the future the regulatory intermediate?
- What is the level of analytics, which is accompanied impurities? This I ask because I currently changing specifications and methods ..
- Who sold them being judged?
- Price for 2 tons and 5 tons per year are also registered in our resource fork of pantoprazole for both RSMja: panto chloro and 5-FMBI. Are the current manufacturers, if yes, please status, similar info as above.