15 January 2019

New implementations and new ASMFs/US DMFs in API Plant

 

The second half of the 2018 in R&D API Plant brought further implementations of new technologies in API Pilot Plant Area, i.e. Pimavanserin Tartrate, Dapagliflozin Propanediol Monohydrate and R-Baclofen hydrochloride.

For all of these products, validation of their manufacturing processes got completed with positive results. What is more, R&D API Plant prepared appropriate regulatory documentation for previously implemented products -  Empagliflozin (EU ASMF and US DMF), Chlorpromazine hydrochloride (EU ASMF and US DMF) and the above mentioned Pimavanserin Tartrate (EU ASMF and US DMF).

The documentation is already issued.

All of the above listed products enriched R&D Portfolio with new generation of Active Pharmaceutical Substances.


DISCLAIMER
The above information is presented solely for informational purposes and does not constitute an offer in any sense. Mentioned products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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