Production

Joint-Stock Company «Farmatsevticheskoye Predpriyatiye Obolenskoe» (Pharmaceutical Enterprise Obolenskoe) was founded in 1994. Manufacturing facilities include two plants located in Serpukhov District, Obolensk urban settlement.

The production capacity of the new plant is 120 million packages: 1.6 billion tablets, 120 million capsules and 15 million sachets per year, which is 3 times the production of the first plant.

The plant for the production of solid dosage forms is furnished with state-of-the-art modern equipment, which is safe for humans and the environment and has enabled the establishment of fully automated manufacturing. Large-scale production of non-sterile solid dosage forms has been organized on the basis of wet and dry granulation technologies, as well as direct mixing. The plant’s production capacity ensures stable product quality with large production output..

The plant is distinguished by its high-tech manufacturing due to:

• introduction of professional equipment for dry compaction;
• use of the closed-cycle manufacturing without open dusting. All process stage transfers are carried out inside pipelines automatically;
• use of automatic CIP, WIP equipment washing systems, availability of automatic equipment for cleaning process packaging;
• capacity for handling hydrophobic substances under conditions of deep dehumidification of air in the production premises;
• handling photosensitive APIs using light filters in production premises;
• presence of the introduced CIS labeling system on the packaging;
• introduction of the ERP system based on the compliance of equipment and computer systems with GAMP 5 standards.

The manufacturing sites of JSC PE Obolenskoe have created a total of more than 550 jobs for the population.

The production activities of JSC PE Obolenskoe are carried out on the basis of Drug Manufacturing License No. 00165-ЛС issued by the Ministry of Industry and Trade of the Russian Federation.

The main goal of the company is the development and manufacture of high-quality, efficacious and safe medicinal products that are in demand and competitive in the pharmaceutical market. The company’s manufacturing sites have an operational integrated pharmaceutical quality system in place that complies with the requirements of the Good manufacturing practices (GMP) and ISO 9001.

JSC PE Obolenskoe specializes in the manufacture of dosage forms (tablets, coated tablets, sustained-release tablets, capsules) of various pharmaco-therapeutic groups (venotonic, gastrointestinal, analgesic, anti-inflammatory, antimicrobial, antiviral, etc.).

• State-of-the-art equipment for carrying out physicochemical and chemical methods of analysis.
• Waters ultra-high performance liquid chromatography system and a dosage form dissolution controlling device from the American company Dystek, which help develop and validate innovative methods and introduce them into the operations of the Quality control department.
• Equipment that allows both development and scale-up of the manufacturing technologies of solid dosage forms (tablets and capsules), and such dosage forms as ODT (orally disintegrating tablets), chewable tablets, tablets and capsules with prolonged and modified release of active substances.