“Lekhim” Group of Pharmaceutical Companies continues to construct manufacturing and storage facilities of the third Lekhim-Obukhiv LLC manufacturing site, Kyiv Region, Obukhiv, 126А, Kyivska Str.
Construction phases of the third manufacturing site
Lekhim-Obukhiv LLC, Kyiv region, Obukhiv, 126А Kyivska Str.
Year 2018
– connection of the first power supply input with the capacity of 250 kW;
– completion of design works and receipt of specifications for connecting to the gas distribution system;
– receipt of specifications for connecting to the municipal water supply lines and sewage collection system;
– beginning of installation of the external and internal gas pipeline.
Year 2019
– beginning of internal and external maintenance works in the premises of Block B for storage of medicinal products;
– assembly of the boiler station;
– development of the conceptual design for reconstruction of Blocks A and В in order to build manufacturing and storage facilities;
– completion of design works for connecting to the municipal water supply lines and sewage collection system;
– beginning of site works on connection to the municipal water supply lines and sewage collection system;
– beginning of connection of the second power supply input with the capacity of 1,000 kW;
– beginning of the development of project documentation (General Design and Contract Documents phases) on reconstruction of Blocks A and B in order to build manufacturing and storage facilities;
– installation of cold chambers in Block B (a warehouse for storage of medicinal products) for storage of thermolabile products with the storage conditions of 2-8 0С – 8-15 0С.
Year 2020
– connection of manufacturing and storage facilities to the general gas supply system;
– completion of works on installation of the heating system, water supply lines, sewage collection system, electric lightning, fire-extinguisher system and internal firefighting water system in the Block B warehouse;
– completion of works on installation of the ventilation and air conditioning system in the Block B warehouse;
– completion of works on installation of the in-site utility lines of the firefighting water system;
– completion of works on installation and connection to the municipal water supply lines and sewage collection system;
– completion of maintenance works in the Block B warehouse;
– execution of supply contracts for the main process equipment for manufacture of medicinal products;
– gas supply and boiler station startup.
Year 2021
– scheduled commissioning of the Block B warehouse in January-February;
– scheduled maintenance works of Blocks А and B and installation of utility systems during quarters 1-3;
– scheduled installation of the packaging line in quarter 2;
– scheduled commissioning of the packaging line and utility systems in quarter 4;
– scheduled commissioning of the first stage of production at the end of quarter 4 – beginning of 2022.
Year 2022
– Q1 2022 – construction and assembly of storage facilities and secondary packaging departmentt were completed. Additionally commissioning works of packaging line and labeling machine for tamper evident seals and cartons coding in “TRACK & TRACE” system were conducted.
– On May 05, 2022 the representative of the State Service of Ukraine on Medicines and Drugs Control inspected LEKHIM-OBUKHIV LLC for availability of the material and technical facilities, qualified personnel as well as conditions for industrial production of the medicinal products.
– On 10.05.2022 based on the results of the inspection the State Service of Ukraine on Medicines and Drugs Control granted the License for manufacturing of the medicinal products (License Unnumbered, valid from 10.05.2022) to LEKHIM-OBUKHIV LLC. The License authorizes the following manufacturing operations to be conducted at the place of activity: secondary packaging, storage of raw materials, materials, finished products, and certification and batch release of the finished product batches.
– Q3 – Q4 2022 – preparation for commissioning of the production line for powders for solution for injection, for assembly of the clean rooms of the sterile products department, as well as engineering networks.
By the end of year 2022, it is planned to complete construction and assembly of the physical and chemical analysis laboratory and ventilation and air conditioning system.
Years 2023-2024
- On 13-15.12.2023, representatives of the State Service of Ukraine on Medicines and Drugs Control (State Medical Service) inspected the secondary packaging site of the LLC LEKHIM-OBUKHIV for compliance with the requirements of Good Manufacturing Practice.
- On 05.03.2024, a certificate of compliance of the conditions of manufacture of medicinal products with the requirements of Good Manufacturing Practice was received for the manufacturer LLC LEKHIM-OBUKHIV, a secondary packaging site at the place of business activity: 126 A Kyivska Str., Obukhiv, Kyiv Region, Ukraine 08700 (production operations: certification of sterile drug batches; packaging: secondary packaging).
- In March-April 2024, submission of an application for accreditation of the physical and chemical laboratory is planned.
- In the second quarter of the year 2024, putting into operation of a site for filling with the powders for solution for injections is planned.
- In the third quarter of the year 2024, putting into operation of the first stage of reconstruction of the industrial warehouse complex at the address: 126A Kyivska Str., Obukhiv, Kyiv Region, as well as the start of construction and installation works of the microbiological laboratory and a new warehouse building are planned..
Our certificates:
