- 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) 1:

-How big are the manufacturer, batch size, the size of the production in 2014 and 2015 -In annex TDPji we get in 2014. Check out or working under these RoSih, we need a detailed RoSe from the current starting materials.If you happen to be a part of the process to explain outsourcajo.Check for current keyword ŠM approved resourcesOr is the process of zvalidiran, which rates on?What is GMP level, assuming if you would in the future be regulatory intermediate?-What is the level of impurities, which are accompanied by Analytics? I'm asking because I am currently changing specifications and methods..Who sold them who rule?-Price for 2 tons and 5 tons per year They are also registered in our source CEPu for pantoprazole for both RSMja: panto and 5-chloro FMBI. Or the producers, if yes, ask for a status similar to the info as above.

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.