Farmacija d.o.o. Tuzla has the exclusive world-wide licence to all intellectual property related to Enkorten. Patent is granted in USA, Russia, China and Australia and pending in other countries
Manufacturing process is organised in three segments:
1) Both peptides as active substances are synthesised by the PolyPeptide Laboratories, USA, in the GMP compliant and FDA certified facilities (www.polypeptide.com). Peptides are released for further manufacturing by Certificate of Analysis based on FDA and EMEA requirements.
2) Finished lyophilised product Enkorten is manufactured by BAG Health Care, Germany (www.bag-germany.com), according to GMP requirements.
3) Control of finished product Enkorten is done in certified laboratory in Germany based on EMEA requirements. Analysis includes 16 tests, which demonstrate high quality of Enkorten. Release of Enkorten as a final product is done by Marketing Authorization Holder Farmacija d.o.o. Tuzla, Bosnia and Herzegovina.
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