Commercial API production

Department of Pharmaceutical Products

Commercial API manufacturing, contract manufacturing of drug forms, medicinal products

The Institute’s offer in the field of pharmacy includes comprehensive support for pharmaceutical companies and research centres.

We deal with:

  • developing technologies for the production of active substances (API)
  • commercial production of active substances (API) – batches ranging from grams to several hundred kilograms (all manufactured pharmaceutical substances are certified by the Chief Pharmaceutical Inspectorate’s GMP certificate)
  • manufacture of active substances for clinical trials
  • developing technologies for manufacturing medicinal products
  • we offer a full range of contract manufacturing services for medicinal products and investigational medicinal products

API offer

SubstanceCAS numberField of applicationAvailable certificates
1. Alfacalcidol41294-56-8calcium metabolism regulator, vitamin D analogueCEP, GMP, ASMF
2. Anastrozole20511-73-1anti-cancer, non-steroidal aromatase inhibitor,GMP, ASMF
3. Calcifediol monohydrate63283-36-3calcium metabolism regulator, vitamin D analogueCEP, GMP, ASMF
4. Calcitriol32222-06-3calcium metabolism regulator, vitamin analogueDASMF
5. Carvedilol72956-09-3cardiovascular drug, beta-blockerGMP,ASMF
6. Cilostazol73963-72-1phosphodiesterase PDE3 inhibitor – inhibits platelet aggregation and dilates blood vesselsASMF
7. Cladribine4291-63-8purine antagonist, hairy cell leukaemia, chronic lymphocytic leukaemia, non-Hodgkin’s lymphoma, acute myeloid leukaemiaGMP, ASMF
8. (+)-Clopidogrel Hydrogen sulphate, polymorphic form I120202-66-6platelet aggregation inhibitor, thienopyridine derivativeASMF
9. Genistein synthetic446-72-0isoflavone phytoestrogenASMF
10. Imatinib mesylate polymorphic form α220127-57-1protein kinase inhibitor (inhibits tyrosine kinase receptors)GMP, ASMF
11. Latanoprost130209-82-4open-angle glaucoma, intraocular hypertension, prostaglandin derivativeGMP, ASMF
12. Nitrendipine39562-70-4calcium antagonist (calcium channel blocker)GMP, ASMF
13. Olanzapine polymorphic form I132539-06-1antipsychotic drug, serotonin/dopamine antagonistGMP, ASMF
14. Sunitinib malate341031-54-7renal cell carcinoma (RCC), gastrointestinal stromal tumour (GIST), gastrointestinal stromal tumours (GMP),ASMF
15. Tacalcitol monohydrate57333-96-7psoriasis, vitamin D analogueCEP, GMP, ASMF

Products manufactured at the Institute have:

  • GMP & CEP certificates
  • accreditations (e.g. in Japan)
  • ASMF documentation
Contact
Anna Nikonowicz, PhD Sc.
phone +48 601 191 135
anna.nikonowicz@ichp.lukasiewicz.gov.pl

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