On September 13-15, 2016, “Import substitution” exhibition took place at the Moscow Exhibition Centre “Crocus Expo”, arranged by the Decree of the RF Government (No. 479-r dd. 22.03.2016), and also through the offices of other federal executive bodies and governmental organisations.
FSUE Moscow Endocrine Plan presented projects implemented as part of the Federal target program “Development of pharmaceutical and medical industry of the Russian Federation for the period up to 2020 and beyond”, national import substitution, in accordance with the Enterprise strategic development program.
Among the presented projects: development and introduction of a number of medicines, reconstruction and theological re-equipment of the available industrial spaces and construction of the new, development of substances manufacturing technologies for localization of the full cycle of medicines production,
In 2016, the Enterprise obtained the marketing authorisation for the products “MIDAZOLAM, solution for intravenous and intramuscular administration 5 mg/ml” and “BUPRAXON® sublingual tablets”, in this same year, the completion of the registration of the product “TROPICAMIDE, eye drops, 0.5% and 1.0%” is expected.
In 2017, registration of the medicinal product “CLONAZEPAM tablets 0.2 mg and 0.5 mg” will be completed. Clinical trials of the product “LORAZEPAM film-coated tablets, 1.0 mg and 2.5 mg” have been completed, introduction date - 2018.
In 2018, it is planned to introduce the products “Oxybuprocaine eye drops 0.4%” and “Lornoxicam lyophilisate for preparation of intravenous and intramuscular solution 8 mg”.
FSUE Moscow Endocrine Plant performs the introduction of modern dosage forms - transdermal therapeutic systems. As part of innovation development, the Enterprise also plans to organise the production of medicinal products in transmucosal films.
Implementation of the Enterprise’s development strategy and introduction of new medicinal products are not possible without reconstruction and technical re-equipping of medicinal products manufacturing and construction of an additional production-laboratory- warehouse block.
In Q1 of 2018, it is planned on the basis of facility 1 to perform reconstruction and technical re-equipping of injectables production; the total area of spaces will make 9 960 m2. According to the production program, upon the reconstruction, the renewed lines will provide for production of injectables and eye drops in vials in the quantity of 40 mln, pcs. per year, injectables in pre-filled syringes in the quantity of 30 mln. pcs. per year, and lyophilized products in glass vials in the quantity of 6.5 mln. pcs. per year.
The planned production-laboratory- warehouse block will occupy the area of 4 500 m2. Construction of a new block will allow providing the Enterprise with additional production spaces that comply with the GMP requirements and necessary warehouses that correspond to GSP and GDP standards. On the basis of the block it planned to organise the laboratory for substance chemical synthesis in accordance with GLP requirements.
In 2019, it is planned to put in operation the Enterprise’s subsidiary for substances production in order to provide the Russian pharmaceutical industry with active pharmaceutical ingridients (APIs) in production of strategically valuable medicinal products and VEDs. Substances production will be organised in three directions: Controlled thebaic APIs made of raw plant materials, APIs obtained by chemical synthesis method (controlled and non-controlled), and APIs made of animal raw materials. As a result of the project implementation, the share of the domestic products in sales volume in the RF market will grow from 35 to 52% or from 14.4 tо 21.7 bln. rub./year; notably, it is planned to obtain 100% import substitution with respect to active pharmaceutical ingridients made of raw plant materials and controlled central action analgesic substances obtained by chemical synthesis method.
During the work at the exhibition, apart from the presentation of Enterprise’s import substitution activities, FSUE Moscow Endocrine Plant representatives became participants of the event business program. Deputy Director for medicines introduction, Elena Ezhova, took part in the conference “Actual questions of development and production of import-substituting products in pharmaceutical and medical industry” making a report “VEDs import substitution as a factor of social security provision”.
On the exhibition opening day the collective exposition was attended by the Director of the Department for Development of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation, Olga Kolotylova.
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