PHS-Tomskhimpharm JSC

Company Profile

Address:	211, Prospekt Lenina, Tomsk, Tomsk Region, 634009 Telephone/fax: (382-2) 40-28-56
Number of SKU:	12 items
Awards and Achievements:	The largest manufacturer of finished pharmaceutical products in Western Siberia. GMP-certified since 2010. The Company celebrated its 80th anniversary in 2016.

Resources and Capabilities

Total area:	30,144 thd. sqm.
Manufacturing area:	11.7 thd. sqm.
Manufacturing dosage forms:	Liquid dosage forms Nasal spray Solid dosage forms film-coated tablets; orodispersible tablets;
Infrastructure:	PHS-Tomskhimpharm JSC has all the necessary infrastructure in place to ensure high-quality product manufacturing, compliant with the international standards. • The enterprise has storage facilities necessary for storage of raw materials, consumables and finished products. To provide energy resources, the facility is equipped with: • a gasified boiler house; • independent power inlets; • autonomous electric power sources (gas powered electrical generator units) • oxygen and nitrogen generators; • compressor room for compressed air generation.

Management

General Director

Vadim Danilov

In 2004, Mr. Danilov graduated from Tomsk Polytechnic University majoring in Economics and Company Management. He began his career the same year with OJSC Industrial and Construction Bank. In 2008, he joined OJCS NOMOS-Bank, while in 2011 Vadim continued his work at Property Management Department of Drilling Service Company GRAND LLC.
In 2014, Vadim Danilov was Deputy General Director for Commercial Affairs of PHS-Tomskhimpharm JSC.
In 2017, he completed with distinction the professional retraining course at the National Research Tomsk State University for training managerial staff for national economy organizations of the Russian Federation.
On February 13, 2018 he was elected General Director of PHS-Tomskhimpharm JSC.

History and Milestones

In 1913, the first pharmaceutical warehouse was opened in Tomsk. 6 years later at its premises the soap, galenic and chemical manufacturing was launched. In 1936, the pharmaceutical warehouse was converted into a chemical and pharmaceutical plant that manufactured tinctures, extracts, drops, ointments, adhesive bandages and tablets.
During the USSR era, the Tomsk plant turned into one of the largest state enterprises and played the key role in development of the national pharmaceutical industry over decades.
In 1992, the enterprise was reincorporated as a Joint-Stock Company.
In 2004, the Tomsk plant joined Pharmstandard Group.
Over two subsequent years, it reconstructed and refurbished the QC microbiological laboratory. The laboratory was licensed to conduct activities involving use of infectious agents and works with RG3-4 microorganisms.
The critical raw material warehouse was reconstructed, the sampling area was equipped with a “clean room” module.
In 2007, Pharmstandard JSC and Solvay Pharma SAS, France (Solvay) signed an agreement for manufacturing of two Solvay Pharma products in Russia — Imudon and IRS 19. Its finished product manufacturing and packaging was decided to arrange at PHS-Tomskhimpharm JSC.

2010

VNIIS JSC audited the quality management system:
• Obtained Certificate of Compliance with GOST R 52249-2009 “Quality Management System. Requirements”.
• Obtained Certificate of Compliance with GOST ISO 9001-2008 (ISO 9001-2008) “Quality Management System. Requirements”.

2014

Obtained Certificate of GMP Compliance, issued by the State Training Centre for Good Manufacturing / Distribution Practice of SE UPQI (Ukraine): 048/2014/SAUMP/GMP

2015

Mastered new product manufacturing:
• Glycine Extra, nutrition tablets;
• Clarithromycin, film-coated tablets, 500 mg.
• Levofloxacinum, film-coated tablets, 250 mg, 500 mg, 750 mg.
• Magnelis® B6 forte, film-coated tablets, 100 mg + 10 mg.
• Mycoderil, cream for external use, 1%.
Three manufacturing sites of the company obtained Resolutions on GMP Compliance of the manufacturer of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation:
• at 211, Prospekt Lenina, Tomsk - No. GMP -0012-000014/15 (dd.10.03.2015);
• at 89, Rosa Luxemburg street, Tomsk - No. GMP -0012-000015/15 (dd.10.03.2015);
• at 32, Proletarskaya street, Tomsk - No. GMP -0012-000016/15 (dd.10.03.2015).

2016

Mastered new product manufacturing:
• Zilacomb, film-coated tablets, 300 mg + 150 mg;
• Tenofovir, film-coated tablets, 300 mg.
By the inspection results conducted by VNIIS JSC, PHS-Tomskhimpharm JSC obtained Certificate of Compliance with GOST ISO 9001-2015 “Quality Management System. Requirements”.

2017

Launch of manufacture of 6 new products including pharmaceutical products with extended release:
• Alvelon-MF film-coated tablets, 400 mg
• Gliclazide MB Pharmstandard extended release tablets, 30 mg, 60 mg
• Formetin® Long film-coated tablets, 750 mg, 850 mg, 1000 mg
• Gluconorm® Plus film-coated tablets, 2.5 mg + 500 mg, 5 mg + 500 mg
• Cyclogemal film-coated tablets, 250 mg
• Clarithromycin extended release tablets, film-coated tablets, 500 mg
Ministry of Industry and Trade of the Russian Federation issued GMP certificates to three manufacturing sites of the company validating compliance of the pharmaceutical products with the requirements of Good Manufacturing Practice No. GMP-0012-000137/17, No. GMP-0012-000143/17, and No. GMP-0012-000144/17 dated 25.01.2017.

2018

The reconstruction of the industrial site was started in order to bring it into compliance with the GMP requirements and arrangement of the manufacture of products within the framework of the project with BIOCAD CJSC.
The redevelopment and repair of the ointment production site into the pilot industrial site of the central factory laboratory was carried out, wherein the development of new drug technologies is being conducted. The power supply system has been reconstructed at manufacturing site No. 3. A moisture removal system is installed in the controlled areas of the raw materials and supplies warehouse.
GMP Certificates Nos. GMP-0012-000252/18, GMP-0012-000265/18, GMP-0012-000266/18 dated May 29, 2018 were issued by the Ministry of Industry and Trade of the Russian Federation for the three manufacturing sites.

2019

Repair of the ventilation system from exhaust hoods and gas chromatographs of the central factory laboratory was performed, equipment for package labeling was prepared.
Certificate of compliance with the requirements of GOST R ISO 9001-2015 in regards to the development and manufacture of medicinal products No. ROSS RU.31798.00019 (dated May 7, 2019).
License No. FS-99-02-006902 dated January 30, 2019 was issued for the performance of pharmaceutical activities at the following address: 211 Lenin Avenue, Tomsk, Tomsk Region, 634009.

2020

The "clean rooms" ventilation system was reconstructed, cold water supply and condensate collection systems of the tablet formulations manufacture workshop were upgraded.

2021-2022

Repairs were carried out for the premises of the shop laboratory of the quality control department, microbiological and central factory laboratories, the sampling room of the warehouse complex, and the tablet and granule department of Allohol production, upgrades are being performed for the cooling system of the area of gas powered electrical generator units.
Certificates of GMP compliance for the Eurasian Economic Union were received (Certificate No. GMP/EAEU/RU/00004-2021 dated April 5, 2021 for the manufacturing site at the address: 32 Proletarskaya Street, Tomsk; Certificate No. GMP/EAEU/RU/00003-2021 dated April 2, 2021 for the manufacturing site at the address: 211 Lenin Avenue, Tomsk; Certificate No. GMP/EAEU/RU/00005-2021 dated April 5, 2021 for the manufacturing site at the address: 89 Roza Luxembourg Street, Tomsk).
Certificate of compliance with the requirements of GOST R ISO 9001-2015 in regards to the development and manufacture of medicinal products No. ROSS RU.32102.01065 (dated May 7, 2022).

Development Plans

Equipping the warehouse complex with a temperature and humidity monitoring system. Reconstruction of the ventilation system for the drug manufacturing site, reconstruction of the air preparation system for the manufacturing site process equipment, replacement of compressed air supply equipment for the manufacturing equipment.

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