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  • A recombinant and analog human insulins API workshop

A recombinant and analog human insulins API workshop

The production building area is 6000 m2. A complex of clean rooms with an area of 3,500 m2, including C and D clean-grade rooms. Production capacity - 400 kg of the API per year.

Human insulin hexamer 3D ribbons

The «Import-Substituting Production of Recombinant and Analog Insulin from Proprietary Substance project» has been under way since 2016 and supported by the Industry Development Fund of the Russian Federation.

The «Medsintez» plant plans to manufacture API of recombinant and analog insulin (Aspart, Glargin) for subsequent use in its own production of finished dosage forms.

In September 2017, own insulin API, Rosinsulin, was registered, at the end of 2018 – the analog insulin API Rosinsulin aspart, a decision by the RF Ministry of Health is expected on adding an analog preparation, Rosinsulin glargine, to the State Register of Medicines.

The implementation of the project will allow to give up purchasing foreign substances and create a full-cycle insulin production. The domestic production of the substances will help reduce prices for finished insulin by 15-20% relative to import prices. The insulins will be produced in the most convenient and familiar finished dosage forms for patients: in cartridges and syringe pens.

For the project, the following have been created at the «Medsintez» plant:

A modern R&D lab for genetics and biotechnology (2014)

A pilot zone (for developing a technology for the production of recombinant drugs, including the API of analog insulin forms) (2015)

RHI API industrial production with capacity up to 400 kg/year (2016-2020)

vk.com fotoekbrus 81

Quality

Quality, safety and efficacy of medicines are «Medsitntez» plant's top priorities.

Знак GMP

The Quality Director's service structure, which includes the quality control and assurance departments, is in full compliance with GMP standards.

The core staff was trained at Bayer AG in Leverkusen and Berlin. All plant employees were trained in GMP requirements at special training organizations or at the enterprise itself.

The plant has the МС ISO 9001:2015 quality control system in place.

Quality control of finished products is carried out in the plant's laboratories accredited by Roszdravnadzor and FMBA of the Russian Federation.

  • Sterile boxing laboratory of the workshop for the production of infusion solutions2.jpg
    Sterile boxing laboratory of the workshop for the production of infusion solutions2.jpg

The Medsintez plant’s awards:

A prize of the Russian Government

for achieving significant results in terms of quality and services, as well as for the implementation of highly effective management techniques (2007)

A prize of the Commonwealth of Independent States

for achievements in the field of product and service quality (2009)

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Torgovaya 15, Novouralsk, Sverdlovsk region, Russia, 624130

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