Skopinpharm

MANUFACTURE

SKOPINPHARM LLC is a modern and dynamically developed Russian pharmaceutical company that manufactures drugs and medicines. The factory has been constructed with due reference to the requirements set out in the GMP regulations.

TODAY
– Output:
1,200,000,000 capsules/tablets a year
300,000 containers of blood plasma with clotting factors a year
– Biotechnological 4-phase blood preparation shop
– Modern laboratory

TOMORROW
– Albumin manufacturing building – 2017
– Cytostatic agent manufacturing – end of 2018
– Formulation manufacturing: lyophilization and pre-filled syringes - 1st three-monthly period of 2019.­


Licensed manufacturing:

• Complete unsterile medicine manufacturing cycle: capsules, uncoated tablets and film-coated tablets.
• Complete sterile medicine manufacturing cycle: human blood preparation components.
• Secondary packages for sterile medicines, vaccines, monoclonal antibodies, cytostatic agents, beta-lactamic antibiotics, hormones.
• Frozen-dried blood preparation components

Partnership with International Manufacturers
Pharmimex JSC and Skopinpharm LLC are periodically audited by international companies for compliance with manufacturing phase distribution and localization requirements applicable to the area of the Russian Federation.

Audits had been successfully conducted by the following companies:

MANUFACTURE:
• Novartis
• Octapharma

DISTRIBUTION:
• Octapharma
• Novartis
• Shire
• MSD
• CSL 
• GlaxoSmithKline
• Alexion
• Biomarin
• Actelion
• Biotest
• Johnson & Johnson

As provided by the Skopinpharm auditing results, a number of drug manufacturing localization agreements has been concluded to deliver products under Federal and regional therapeutic practice programs and some agreements are currently expected to be signed by the parties.

In addition, Pharmimex JSC schedules constructing a pharmaceutical complete-cycle blood preparation factory at a new 10 ha Skopinpharm's area jointly with Octapharma Nordic AB (Sweden).

This project is to be implemented to utilize human blood plasma producing its derivatives in the Russian Federation. This project will make it possible to create state-of-the-art medicine and drug manufacturing solutions and to use locally collected plasma for production of medicines according to the strategy accepted under the national program "Pharma-2020".