LEKKO CJSC

Company Profile

Address: Zavodskaya Street, Building 278, Volginsky settlement, Petushinsky District, Vladimir Region, 601125
Phone: 8 (4922) 77 32 90
Staff: 500 employees
Product Range: 36 items
Number of SKU: 58 items
2021 Output: 58.91 mln packs.
Awards and Achievements LEKKO CJSC is a Russian innovative company, specialized in R&D, manufacturing and promotion of highly efficient medicinal products. Its expertise is drug manufacturing, proved by its over 20 year old success story in the market.
GMP-certified.
GOST ISO 9001-2015 (ISO 9001:2015) Certificate of Conformity

Resources and Capabilities

Capacity: 130 mln packs per year.
Total area: 20.08 thd. sqm.
Manufacturing area: 8.37 thd. sqm.
Number of production lines: 12
Manufactured dosage forms: Liquid:
  • eye, nasal and ear drops
  • sprays
  • solutions, including injection solutions
Solid:
  • capsules
  • powders
  • dispersible tablets
  • film-coated tablets
Soft:
  • gels
  • creams
Infrastructure: LEKKO CJSC has all the necessary infrastructure in place to ensure high-quality product manufacturing:
• Production of medicinal products is arranged in 4 production shops involving 15 work sites with a total area of more than 8,000 m2.;
• The company has warehouses for storage of raw stuff, materials and finished products. The area of the warehouses is more than 8,300 m2, and the number of pallet units for storage of raw materials, in-bulk and finished products, incl. under the cold chain conditions, is more than 8,000.
To ensure energy supply, the company is equipped with the following:
• gas-fired boiler-house;
• two independent energy lines;
• compressor house for compressed air generation.
The work sites are equipped with PW and WFI generation systems.

Management

General Director

Andrei Skorokhod

1998 – Majored in TPP Engineering by the Far Eastern State Technical University.

2004 – 2010 – held the position of Deputy General Director for Commerce;

2010-2018 - was General Director of PHS-Tomskhimpharm JSC.

2013 – Obtained the MBA degree of the Tomsk Research and Development University.

Since 2018 – has been General Director of LEKKO CJSC

 

History and Milestones

LEKKO pharmaceutical company launched its operations with probiotics in the premises of one of the Pskov Biologics Factory’s manufacturing buildings back in 1993. Subsequently, the product range has been significantly expanded with nasal and eye drops, anti-inflammatories and antibiotics.
2005 Reconstructed and upgraded the manufacturing facilities; put in commission a new production area for solid dosage forms.
2006 Started arrangements for manufacturing of genetically engineered products.
2008 Completed clinical trials and obtained registration ; started manufacturing of the first genetically engineered product, TB diagnostic test — Diaskintest®.
2010 Upgraded its antibiotic production line.
2012 Joined Pharmstandard Group.
2013 Obtained GMP and GOST ISO 9001-2011 (ISO 9001:2008) Certificates of Conformity.
Renewed Drug Manufacturing License; reconstructed the lyophilization site of workshop No. 3 resulting in doubled Acipol output.
2015 Put in commission a PW generation, storage and distribution system (capacity — 1,500 l/h).
Reconstructed the kefir fungi production area; obtained reconfirmation of GMP and GOST ISO 9001-2011 (ISO 9001:2008) Certificates of Conformity. Renewed Drug Manufacturing License.
2016 Arranged a New Technologies Department; put in commission a soft dosage form workshop- and a PW generation, storage and distribution system (capacity — 2,000 l/h).
To enhance its product quality
• Upgraded its process equipment (replaced the double-door steam sterilizer, tanks and vessels, capsule filler in the bacterial drug workshop, cartoning machine in the packaging workshop);
• Equipped its QC analytical lab with another HPLC platform, as well as with a spectrophotometer and a portable gauge to measure the total organic carbon content. Obtained:
• GOST ISO 9001-2015 (ISO 9001:2015) Certificate of Conformity.
2020 Put in commission an area for production of antibiotics presented as tablets and film-coated tablets. Started production of EXPRESS dispersible antibiotics. Expanded the production of eye and nasal drops.
Obtained GOST ISO 9001-2015 (ISO 9001:2015) Certificate of Conformity No. РОСС RU.ИМ00.И0136 (dated March 11, 2019).
Obtained GOST ISO 9001-2015 (ISO 9001:2015) Certificate of Conformity No. РОСС RU.ИМ00.И0136 (dated March 11, 2019).
2021 During the pandemic, started production of the vector-based bivalent COVID-19 vaccine in the shortest period possible.
Obtained:
• conclusion of the Ministry of Industry and Trade of the Russian Federation on compliance of the manufacturer (foreign manufacturer) of medicinal products for human use with the requirements of Good Manufacturing Practice No. GMP 0013-000575/20 (dated November 16, 2020);
• conclusion of the Ministry of Industry and Trade of the Russian Federation on compliance of the manufacturer (foreign manufacturer) of medicinal products for human use with the requirements of Good Manufacturing Practice No. GMP 0013-000576/20 (dated November 19, 2020).
Reconstructed the bacterial drug production area. Launched a laboratory building including a microbiological laboratory and an analytical laboratory fitted with up-to-date equipment. Put in commission a new warehouse complex with a total area of more than 8,000 m2.

Development Plans

Expansion of the area for production of antibiotics presented as tablets and film-coated tablets;
Reconstruction of the solution preparation area;
Reconstruction of the packaging area, launching 2 semi-automatic cartooning machines;
Expansion of the water treatment facilities;
• Reconstruction of the WFI storage and distribution system;
Reconstruction of the injection solution production area;
Arrangement of a dietary supplement probiotic production area.

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