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.

CONTACT
Anna Nikonowicz, PhD Sc.
phone +48 601 191 135
anna.nikonowicz@ichp.lukasiewicz.gov.pl

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

OFERTA API

1,
SubstanceCAS numberField of applicationAvailable certificates
1. Alfacalcidol 41294-56-8 calcium metabolism regulator, vitamin D analogue CEP, GMP, ASMF
2. Anastrozole20511-73-1anti-cancer, non-steroidal aromatase inhibitor, GMP, ASMF
3. Calcifediol monohydrate 63283-36-3 calcium metabolism regulator, vitamin D analogue CEP, GMP, ASMF
4. Calcitriol32222-06-3calcium metabolism regulator, vitamin D analogueCEP, ASMF, GMP
5. Carvedilol72956-09-3cardiovascular drug, beta-blockerGMP, ASMF
6. Cladribine4291-63-8purine antagonist, hairy cell leukaemia, chronic lymphocytic leukaemia, non-Hodgkin’s lymphoma, acute myeloid leukaemiaGMP, ASMF
7. (+)-Clopidogrel Hydrogen sulfate, polymorphic form I120202-66-6inhibitor agregacji płytek krwi, pochodna tienopirydynyASMF
8. Eksemestan107868-30-4aromatase inhibitorASMF
9. Genistein synthetic 446-72-0 isoflavone phytoestrogen ASMF
10. Imatinib mesylate polymorphic form α220127-57-1 protein kinase inhibitor (inhibits tyrosine kinase receptors) GMP, ASMF
11. Latanoprost130209-82-4open-angle glaucoma, intraocular hypertension, prostaglandin derivativeASMF
12. Nitrendipine39562-70-4calcium antagonist (calcium channel blocker)ASMF
13. Olanzapine polymorphic form I132539-06-1antipsychotic drug, serotonin/dopamine antagonistASMF
14. Sunitinib malate 341031-54-7 renal cell carcinoma (RCC), gastrointestinal stromal tumour (GIST), gastrointestinal stromal tumours (GMP), ASMF
15. Tacalcitol monohydrate 57333-96-7 psoriasis, vitamin D analogue CEP, GMP, ASMF

Products manufactured at the Institute have:

  • GMP & CEP certificates
  • accreditations (e.g. in Japan)
  • ASMF documentation

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