Pharmstandard-UfaVITA JSC

Company Profile

Contact information:	Address: 28, Khudayberdina str., Ufa, Republic of Bashkortostan, 450077 24-hour phone line: (347) 272-92-85;
Staff:	1900 employees
Product range:	127 items
Number of SKU:	230 items
2021 Output:	132 mln packs
Awards and Achievements:	The Best Industrial Company of the Republic of Bashkortostan in 2009; Laureate of “The Best Manufacturer in Ufa” City Competition in nomination of “The Leader of Industry 2011”; Laureate of “The Best Manufacturer in Ufa” City Competition in nomination of “Dynamic Development and Excellent Financial Performance 2014”. GMP-certified since 2010.

Resources and Capabilities

Capacity:	200 mln packs
Total area:	42 thd. sqm.
Manufacturing area:	26 thd.sqm
Number of production lines:	22
Manufacturing dosage forms:	Non-sterile manufacturing, Solid dosage forms uncoated tablets coated tablets film-coated tablets dispersible tablets pills capsules Sterile manufacturing, Liquid and freeze-dried dosage forms liquid dosage forms in ampoules, vials, cartridges, plastic ampoules, polymer dropper bottles, pre-filled syringes: injectables, eye drops lyophilisates concentrates for solutions for infusion inhalation solutions
Infrastructure:	Pharmstandard-UfaVITA JSC has all the infrastructure necessary to support production: the manufacture of finished products is organised in 7 workshops with a total area of about 26,000 m²). The company has the necessary warehousing facilities to store raw materials, supplies and finished goods. The warehousing area is more than 6,000 m², and the storage area for raw materials, in-bulk and finished products in the cold chain exceeds 1,000 m². To provide energy resources, the facility is equipped with: • gasified boiler house;• two independent power inlets; • oxygen and nitrogen generators; • compressor room for compressed air generator. The production areas are equipped with purified water and water for injection generation systems. The company has local treatment facilities for complete treatment of wastewater according to standards.

Management

Director General

Nail Zinurovich Nizamutdinov

In 1992, graduated from Bashkir State University majoring in Chemistry and the same year, started his career at Ufa Vitamin Plant JSC.

Worked his way up through the ranks as Area Supervisor, Workshop Supervisor, Deputy Chief Engineer, Deputy Director General for Production, Chief Engineer, and Chief Technical Officer.

Under the leadership of N. Nizamutdinov, the company has arranged the manufacture of a new generation of anti-tumour agents, launched aseptic production of biotechnological products, built a specialised biochemical laboratory, and is building a new facility for the blood clotting factor VIII project.

N.Z. Nizamutdinov was awarded by R.F. Khabirov, the Head of the Republic of Bashkortostan, with a merit badge ‘For Selfless Work in the Republic of Bashkortostan’ for many years of hard work and deep expertise; the Diploma of Merit of Ufa Administration and the Diploma of Merit of the Ministry of Industry and Innovation Policy of the Republic of Bashkortostan for high professional skills and excellent work; and the Diploma of Merit of the Ministry of Industry and Innovation Policy of the Republic of Bashkortostan for his great personal contribution to the development of industry and many years of hard work.

Elected as Director General of Pharmstandard-UfaVITA JSC on 30 April 2022.

History and Milestones

In 1916, a confectionery plant was opened in Ufa, in 1941 to be converted into a vitamin plant based on the production facilities transferred to the Ural region. The plant was the first to manufacture the pharmaceuticals that would subsequently become acknowledged nationwide: Pangamate (vitamin B15), Decamevit®, Aerovit®, Complivit®, Selmevit®, and a wide range of other high-performance pharmaceuticals and coenzymes in freeze-dried forms for injections.

2003
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2004

Joined Pharmstandard Group. In 2004 it was renamed into Pharmstandard-UfaVITA JSC.

2010

Put in commission:
• Workshop No.4 for injectables — manufacturing of injactables in ampoules with terminal sterilisation;
• Workshop No.4 for insulin products – aseptic manufacturing of products in vials and cartridges;
• Workshop No.1 for multivitamins — manufacturing of film-coated tablets;
• Workshop No.4 for lyophilized products — manufacturing of lyophilisates for injection solutions;
• Workshop No.5 for injectables — expanded manufacturing area for injectables in ampoules.
Put in commission liquid dosage form packaging area (Workshop No.5).
Launched contract manufacturing of F.Hoffman—La Roche cold-chain products.

2012

Expanded manufacturing of injectables in ampoules: put in commission another injectable area (Workshop No.5 ).

2013

Put in commission Workshop No.2 for manufacturing of cytostatics, including the manufacturing area for injactables in liquid and freeze-dried forms, manufacturing area for tablets and capsules, packaging area.
Arranged manufacturing processes within the facilities equipped with isolators.

2014

Expanded injectable manufacturing: put in commission the manufacturing area for injactables in pre-filled syringes (Workshop No.4).

2015

Obtained Certificate of GMP Compliance Manufacturer, in accordance with Directive 2003/94/EC, issued by State Agency of Medicines of the Republic of Latvia: ZVA/LV/2015/004H (dd.30.04.2015).

2016

Obtained Resolution on GMP Compliance of the manufacturer of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No.GMP -0002-000125/16 (dd.10.10.2016).
Obtained Certificate of Compliance with GOST R ISO 9001-2015 No.ROSS RU.IM00.I0035 (dd. 22.05.2016).

2017

Obtained Statement on GMP Compliance of the manufacturer of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No.GMP-0002-000155/17 (dd. 02.03.2017). Certificate of Compliance with GOST R ISO 9001-2015 (ISO 9001:2015) (dd. 26.04.2017) was issued upon audit of the quality management system Obtained Drug Manufacturing License No. 00071-ЛС (dd. 01.12.2017). Completed construction of a new building for FPPs manufacturing with total area of 10500 sq.m. (6 floors) for the placement of manufacturing facilities and laboratories.

2018

2019

Obtained Certificate of Compliance with GOST R ISO 9001-2015 for the development, manufacturing and distribution of medicinal products: No. ROSS RU.31798.00022 (dd. 21.05.2019). Obtained Resolution on GMP Compliance of the manufacturer (foreign manufacturer) of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No. GMP 0002-000396/19 (dd. 16.07.2019). Obtained Resolution on GMP Compliance of the manufacturer (foreign manufacturer) of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No. GMP 0002-000397/19 (dd. 16.07.2019).

2020

Obtained Resolution on GMP Compliance of the manufacturer (foreign manufacturer) of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No. GMP 0002-000554/20 (dd. 05.10.2020). Obtained Resolution on GMP Compliance of the manufacturer (foreign manufacturer) of pharmaceutical products for medical use, issued by the Ministry of Industry and Trade of the Russian Federation: No. GMP 0002-000555/20 (dated 05.10.2020). Put in commission the area for aseptic production of sterile products in polymer dropper bottles and plastic ampoules. Scaled up the production of components 1 and 2 of the COVID-19 vaccine. Implemented the project on construction and commissioning of the wastewater treatment plant, with complete wastewater treatment according to standards before discharge into the city sewer system.

2021

Obtained Certificate of EAEU GMP Compliance: No. GMP/EAEU/RU/00031-2021 (dd. 28.05.2021).
Obtained Certificate of EAEU GMP Compliance: No. GMP/EAEU/RU/00032-2021 (dd. 28.05.2021).
Completed phased commissioning of production facility and laboratories in the new building with production capacity of more than 1.8 billion tablets per year.

Development Plans

Q3

2022

Commissioning of the production area for blood clotting factor VIII.

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