Manufacturing

The PIQ-PHARMA GROUP of companies produces medicines at its own facilities. The technical level and organization of the production process comply with the requirements of the national standards of the Russian Federation, and also meet the European quality standards in the field of pharmaceutical production and GMP.

The production base of the company is made up of factories for the production of finished medicines and the chemical synthesis of pharmaceutical substances. Its own production facilities allow PIQ-PHARMA to rapidly introduce new dosage forms, as well as to manufacture the existing range of products.

License for the production of drugs (PIQ-PHARMA CHEM)

License for the production of drugs (PIQ-PHARMA LEC)

Conformity to GMP

Pharmaceutical license

 

API manufacturing — PIQ-PHARMA CHEM

In 2011, PIQ-PHARMA LLC opened the production of pharmaceutical substances at the PIQ-PHARMA CHEM LLC on the territory of the former Belgorod Vitamin Plant, once the country’s largest producer of vitamins. The accumulated human and technological potential for the chemical synthesis of substances led to the decision to establish such production here.

High quality products are guaranteed by compliance with technological requirements according industry standards at all stages of production, as well as by quality control.

Laboratory and pilot production lines allow to develop and scale of new products. the enterprise has a pilot site where work is being carried out to improve the technology, making the production of the substance less economically expensive and more environmentally friendly.

Due to the presence of its own production of pharmaceutical substances, PIQ-PHARMA provides a full cycle of production of drugs in Russia.

License for the production of drugs (PIQ-PHARMA CHEM)

 

Manufacturing of Finished Forms — PIQ-PHARMA LEC

In 2015, PIQ-PHARMA put into work the first stage of the finished pharmaceuticals plant PIQ-PHARMA LEC LLC. The event was preceded by the modernization of the site to comply GMP standards. The plant is located in the Severny industrial park in the Belgorod district of the Belgorod region.

In November 2016, PIQ-PHARMA LEC LLC received a GMP conclusion.

Today, the plant produces the entire volume of solid dosage forms PIQ-PHARMA, and also the Magnerot® tablets of the German company Wörwag Pharma on contract basis.

In 2020, a new line of liquid non-sterile dosage forms with a total capacity of up to 6,000,000 bottles per year was put into operation at the PIQ-PHARMA LEC production site.

The technical level and organization of production of medicinal products comply with the requirements of the national standard of the Russian Federation “Rules for the production and quality control of medicinal products” (GOST R 52249-2009) and with the European Union GMP rules.

Design capacity of the enterprise (per year):

  • 500 million pills;
  • 100 million capsules;
  • 6 million vials.

 

The company uses advanced production technologies:

  • the production complex is designed and built in accordance with GMP requirements;
  • best-in-class equipment:
        •  IMA (Italy);
        •  KILIAN (Germany);
        •  ROMACO (Italy);
  • modern warehouse complex;
  • highly qualified trained personnel;
  • pharmaceutical quality system.

The automated engineering complex provides the following parameters in the technological and auxiliary areas:

  • the required class of clean room:
        •  overpressure;
        •  air exchange;
        •  environmental conditions;
  • automated systems for the preparation of purified water, compressed air, process steam;
  • computerized systems for monitoring and recording process parameters.

 

An advanced GMP-compliant quality control system ensures:

  • control at every stage of production;
  • records management;
  • quality control of raw materials and materials;
  • quality control of final products;
  • creation of a personnel training system.

 

Possibilities of the warehouse complex PIQ-PHARMA LEC:

  • controlled climatic parameters of storage of raw materials and final products;
  • modern tracking system for raw materials and finished products;
  • 1250 pallet places.