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Polish GMP Inspections at API Plant Finished With Positive Results

Polpharma has announced that the Main Pharmaceutical Inspectorate (MPI) have completed two inspections at its active pharmaceutical ingredients (API) plant in Poland.

Both inspections finished with positive results, and the inspectors will recommend the issue of good manufacturing practice (GMP) certificates for all the substances evaluated.

It was further acknowledged that the API Plant meets GMP requirements, and the certificate makes it possible to sell products worldwide.

This is the best confirmation that Polpharma delivers high-quality products.

In September, the following active substances were accepted by the MPI:

  • Bazedoxifene Acetate
  • Brexpiprazole
  • Aripiprazole Monohydrate
  • Piracetam
  • Carvedilol
  • Tolterodine tartrate
  • Carbamazepine
  • Pentoxifylline

In October, MPI approved another eight active substances:

  • Hydrochlorothiazide
  • Avanafil
  • Alendronate sodium trihydrate
  • Eodolac
  • Ticagrelor
  • Saxagliptin monohydrate
  • Zolendronic acid monohydrate
  • Metronizadole