Technological expansion of the pharmaceutical manufacturing plant at Hungaro-Gal Kft. (Q3915394): Difference between revisions
Jump to navigation
Jump to search
(Changed an Item: add summary) |
(Changed an Item: Adding English translations) |
||||||||||||||
| Property / summary | |||||||||||||||
The development is related to the production of Cistergin and Diareptan, which reduce the side effects of cancer treatment chemotherapy treatment, which have an international patent (USA patent 5,366,723). We attach an advance licensing agreement for patent exploitation concluded at the beginning of 2016. Once the clinical trials have been carried out and the right of exploitation has been obtained, the converted Nagyga road site may start producing the developed new products. Hungaro-Gal Kft. In March 2015, DBSYS Informatika Kft. commissioned the company to introduce the inventory, accounting, accounting, production management, inventory and quality control system within the framework of the Magister Integrated Corporate Management System — IPAR 4.0. We attach the contract of business and the system monitoring and operation contract. Within the integrated (IPAR 4.0) system, modules 2, 3 and 4 covering production, control and decision support, as well as procurement, logistical areas, operate at the company, which will meet the general requirements relevant to the existing systems and the requirements of functional areas with continuous improvements at the latest by the end of the project. The developer’s declaration of compliance with the production management and production programming system is attached. The company has about 800 kinds of raw materials, pharmaceutical active ingredients, vehicle, packaging material and paper. Production operates according to a pre-established annual schedule, which is typically due to twofold: seasonal use of certain products, on the other hand, changing and cleaning production lines takes several days. The condition for starting production according to GMP conform is the up-to-date knowledge of the raw material stock and the availability of all the necessary materials during the ordering process, from the active ingredient to the thickness of the foil required for shrink wrapping. The production control system shall check the available stock prior to the start of production, indicate any short or limited capacities that may exist and prepare a complex open calculation sheet for the product to be manufactured, ensuring that all direct costs are known during production. Based on the internal calculation information of the company management, the calculation of the total cost of production can be ensured by increasing indirect and overhead costs. By recording in the CRM system, decision-making is ensured for decision-makers based on all the real-world basis and information logged, supported by credible and detailed statistics and statements. (English) | |||||||||||||||
| Property / summary: The development is related to the production of Cistergin and Diareptan, which reduce the side effects of cancer treatment chemotherapy treatment, which have an international patent (USA patent 5,366,723). We attach an advance licensing agreement for patent exploitation concluded at the beginning of 2016. Once the clinical trials have been carried out and the right of exploitation has been obtained, the converted Nagyga road site may start producing the developed new products. Hungaro-Gal Kft. In March 2015, DBSYS Informatika Kft. commissioned the company to introduce the inventory, accounting, accounting, production management, inventory and quality control system within the framework of the Magister Integrated Corporate Management System — IPAR 4.0. We attach the contract of business and the system monitoring and operation contract. Within the integrated (IPAR 4.0) system, modules 2, 3 and 4 covering production, control and decision support, as well as procurement, logistical areas, operate at the company, which will meet the general requirements relevant to the existing systems and the requirements of functional areas with continuous improvements at the latest by the end of the project. The developer’s declaration of compliance with the production management and production programming system is attached. The company has about 800 kinds of raw materials, pharmaceutical active ingredients, vehicle, packaging material and paper. Production operates according to a pre-established annual schedule, which is typically due to twofold: seasonal use of certain products, on the other hand, changing and cleaning production lines takes several days. The condition for starting production according to GMP conform is the up-to-date knowledge of the raw material stock and the availability of all the necessary materials during the ordering process, from the active ingredient to the thickness of the foil required for shrink wrapping. The production control system shall check the available stock prior to the start of production, indicate any short or limited capacities that may exist and prepare a complex open calculation sheet for the product to be manufactured, ensuring that all direct costs are known during production. Based on the internal calculation information of the company management, the calculation of the total cost of production can be ensured by increasing indirect and overhead costs. By recording in the CRM system, decision-making is ensured for decision-makers based on all the real-world basis and information logged, supported by credible and detailed statistics and statements. (English) / rank | |||||||||||||||
Normal rank | |||||||||||||||
| Property / summary: The development is related to the production of Cistergin and Diareptan, which reduce the side effects of cancer treatment chemotherapy treatment, which have an international patent (USA patent 5,366,723). We attach an advance licensing agreement for patent exploitation concluded at the beginning of 2016. Once the clinical trials have been carried out and the right of exploitation has been obtained, the converted Nagyga road site may start producing the developed new products. Hungaro-Gal Kft. In March 2015, DBSYS Informatika Kft. commissioned the company to introduce the inventory, accounting, accounting, production management, inventory and quality control system within the framework of the Magister Integrated Corporate Management System — IPAR 4.0. We attach the contract of business and the system monitoring and operation contract. Within the integrated (IPAR 4.0) system, modules 2, 3 and 4 covering production, control and decision support, as well as procurement, logistical areas, operate at the company, which will meet the general requirements relevant to the existing systems and the requirements of functional areas with continuous improvements at the latest by the end of the project. The developer’s declaration of compliance with the production management and production programming system is attached. The company has about 800 kinds of raw materials, pharmaceutical active ingredients, vehicle, packaging material and paper. Production operates according to a pre-established annual schedule, which is typically due to twofold: seasonal use of certain products, on the other hand, changing and cleaning production lines takes several days. The condition for starting production according to GMP conform is the up-to-date knowledge of the raw material stock and the availability of all the necessary materials during the ordering process, from the active ingredient to the thickness of the foil required for shrink wrapping. The production control system shall check the available stock prior to the start of production, indicate any short or limited capacities that may exist and prepare a complex open calculation sheet for the product to be manufactured, ensuring that all direct costs are known during production. Based on the internal calculation information of the company management, the calculation of the total cost of production can be ensured by increasing indirect and overhead costs. By recording in the CRM system, decision-making is ensured for decision-makers based on all the real-world basis and information logged, supported by credible and detailed statistics and statements. (English) / qualifier | |||||||||||||||
point in time: 8 February 2022
| |||||||||||||||
Revision as of 14:35, 8 February 2022
Project Q3915394 in Hungary
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Technological expansion of the pharmaceutical manufacturing plant at Hungaro-Gal Kft. |
Project Q3915394 in Hungary |
Statements
231,189,594 forint
0 references
1,263,971.585 Euro
0.0027336256 Euro
14 December 2021
0 references
462,379,188.0 forint
0 references
50.0 percent
0 references
23 May 2018
0 references
29 November 2019
0 references
HUNGARO-GAL Gyógyszergyártó és Szolgáltató Korlátolt Felelősségű Társaság
0 references
46°21'23.29"N, 17°47'19.28"E
0 references
A fejlesztés kapcsolódik a rákgyógyítás kemoterápiás kezelésének mellékhatásait csökkentő Cisztergin és a diabetesz betegség tüneteit mérséklő Diareptan gyógytápszer gyártásához, melyek nemzetközi szabadalommal rendelkeznek (USA patent 5,366,723). A szabadalmi hasznosításra 2016. év elején kötöttünk előzetes hasznosítási megállapodást csatoljuk. A klinikai vizsgálatok lefolytatását és a hasznosítási jog megszerzését követően az átalakított Nagygát úti telephelyen megkezdődhet a kifejlesztett új termékek gyártása. A Hungaro-Gal Kft. 2015. márciusában megbízta a DBSYS Informatika Kft-t, hogy a vállalatnál bevezesse a MAGISZTER integrált vállalatirányítási rendszer – IPAR 4.0 – keretében a készlet, nyilvántartási, elszámolási, termelésirányítási, leltározási és minőségellenőrzési rendszert. Az erről szóló vállalkozási szerződést, valamint rendszerfelügyeleti és üzemeltetési szerződést csatoljuk. Az integrált – IPAR 4.0 – rendszeren belül gyártási, kontrolling és döntéstámogatási, illetve beszerzési, logisztikai területeket lefedő 2., 3. és 4. modul elemek működnek a vállalatnál, melyek a folyamatos fejlesztésekkel legkésőbb a projekt befejezéséig teljesíteni fogják a meglévő rendszerek esetében releváns általános követelményeket, illetve a funkcionális területek követelményeit. A fejlesztő nyilatkozatát csatoljuk a termelés-irányítási, termelés-programozási rendszernek való megfelelőségről. A cégnél kb. 800 féle alapanyagot, gyógyszer hatóanyagot, vivőanyagot, csomagolóanyagot, papírárut tartanak készleten. A gyártás előre meghatározott éves ütemterv szerint működik, amelynek oka jellemzően kettős: egyes termékek szezonális igénybevétele, másrészről a gyártósorok átállítása, tisztítása akár többnapos időtartamba is kerül. A GMP konform szerinti gyártás megindításának feltétele az alapanyag készlet naprakész ismerete, illetve megrendelés, gyártási folyamatba történő ütemezése során a szükséges összes anyag rendelkezésre állása a hatóanyagtól a zsugorfóliázáshoz szükséges vastagságú fóliáig. A gyártásfelügyelő rendszer a termelés megindítása előtt ellenőrzi a rendelkezésre álló készletet, jelzi az esetlegesen meglévő szűk, vagy korlátozott kapacitásokat és elkészíti a gyártandó termékre vonatkozó komplex nyitott kalkulációs lapot, ami azt biztosítja, hogy minden közvetlen költség ismert a gyártás során. A cégmenedzsment belső kalkulációs információi alapján, a közvetett és általános költségekkel megemelten biztosítható a teljes gyártási költség kalkulációja. A CRM rendszerben való rögzítéssel biztosított a naplózott minden valós alapokon és információkon nyugvó, hiteles és részletes statisztikákkal és kimutatásokkal alátámasztott döntéselőkészítés a döntéshozók számára. (Hungarian)
0 references
The development is related to the production of Cistergin and Diareptan, which reduce the side effects of cancer treatment chemotherapy treatment, which have an international patent (USA patent 5,366,723). We attach an advance licensing agreement for patent exploitation concluded at the beginning of 2016. Once the clinical trials have been carried out and the right of exploitation has been obtained, the converted Nagyga road site may start producing the developed new products. Hungaro-Gal Kft. In March 2015, DBSYS Informatika Kft. commissioned the company to introduce the inventory, accounting, accounting, production management, inventory and quality control system within the framework of the Magister Integrated Corporate Management System — IPAR 4.0. We attach the contract of business and the system monitoring and operation contract. Within the integrated (IPAR 4.0) system, modules 2, 3 and 4 covering production, control and decision support, as well as procurement, logistical areas, operate at the company, which will meet the general requirements relevant to the existing systems and the requirements of functional areas with continuous improvements at the latest by the end of the project. The developer’s declaration of compliance with the production management and production programming system is attached. The company has about 800 kinds of raw materials, pharmaceutical active ingredients, vehicle, packaging material and paper. Production operates according to a pre-established annual schedule, which is typically due to twofold: seasonal use of certain products, on the other hand, changing and cleaning production lines takes several days. The condition for starting production according to GMP conform is the up-to-date knowledge of the raw material stock and the availability of all the necessary materials during the ordering process, from the active ingredient to the thickness of the foil required for shrink wrapping. The production control system shall check the available stock prior to the start of production, indicate any short or limited capacities that may exist and prepare a complex open calculation sheet for the product to be manufactured, ensuring that all direct costs are known during production. Based on the internal calculation information of the company management, the calculation of the total cost of production can be ensured by increasing indirect and overhead costs. By recording in the CRM system, decision-making is ensured for decision-makers based on all the real-world basis and information logged, supported by credible and detailed statistics and statements. (English)
8 February 2022
0 references
Kaposvár, Somogy
0 references
Identifiers
GINOP-1.2.1-16-2017-00226
0 references