Our products

Ibandronate sodium

CAS No.

138926-19-9

Reference product

Polymorphic form

Monohydrate Form B

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

US DMF readiness

025638

CEP

Pending

Other documentation

Chinese DMF
Korean DMF
Japanese DMF
Brazilian DMF - pending

💉 Available also
in injectable form

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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