02 October 2019

Positive GMP Inspection 17-19.09.2019


On 17-19 September 2019, our API manufacturing site in Starogard Gdański was inspected by GMP Inspectors from the Chief Pharmaceutical Inspectorate.

The reason for this inspection is the expiration date of the current certificates for below list of Active Pharmaceutical Products (APIs):

  1. Apremilast (form N)
  2. Dabigatran etaxilate mesylate
  3. Carvedilol phosphate hemihydrate
  4. Repagilinde
  5. Aripiprazole Lauroxil
  6. Vardenafil hydrochloride
  7. Ibandronate sodium


Addiitionaly our new development : Safinamide Methanesulfonate was the subject of detailed control by GMP Inspectors.


We are happy to annouce that the inspection was successful!

Inspectors will recommend the issue of a GMP Certificate for all of the above APIs - also for the new implementation - Safinamide Methanesulfonate.

DISCLAIMER:
The above note is presented solely for informational purposes and does not constitute an offer in any sense. 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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