Всероссийская GMP-конференция | Obolenskoe
Obolenskoe
Obolenskoe

Office
115162, Moscow, Shabolovka st, 31/11, 4 th floor

Phone/fax
+7 (495) 646-28-68, 646-28-78, 646-28-98

Email
info@obolensk.ru

www.obolensk.ru

 

«JSC «PE «Obolenskoe» (member of Sistema Group) is a Russian pharmaceutical company engaged in the development, production and promotion of modern and high-quality pharmaceuticals in accordance with GMP and ISO international standards.

MISSION

The company produces more than 150 prescription and over-the-counter pharmaceuticals for gastroenterological, cardiologic, phlebologic and neurologic diseases, as well as for the treatment of acute and chronic pain, insomnia, for men’s health and more. The Company’s portfolio includes both innovative and generic pharmaceuticals.

The Company holds all the necessary licenses and certificates for producing pharmaceuticals and carrying out pharmaceutical activities:

  • Pharmaceutical Production License (No. 00165-LS);
  • Pharmaceutical License (FS-99-02-003805);
  • Quality Management System Certificate of Conformity with Regard to the Production of Non-Sterile Pharmaceuticals to the Requirements of GOST R ISO 9001-2015 (ISO 9001: 2015) (ROSS RU.IM00.I0038);
  • Sanitary-Epidemiological Conclusion Certificate No. 50. PR.02.000.M.000022/06/16 certifying the conduct of diagnostic works with RGIII-IV microorganisms in the microbiological laboratory of OBL Pharm.

Production

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.