BDR Pharmaceuticals and Pharmasyntez plan a Kaluga ingredient factory

BDR Pharmaceuticals and Pharmasyntez plan active ingredient production in Kaluga under a trilateral agreement.

A manufacturing agreement for Kaluga

BDR Pharmaceuticals, JSC Pharmasyntez and the Kaluga regional government have signed a trilateral agreement to establish an active pharmaceutical ingredient factory in the region. The planned joint venture brings together the Indian manufacturer and the Russian pharmaceutical group. Kaluga Governor Vladislav Shapsha announced the agreement.

The proposed factory would manufacture active pharmaceutical ingredients, including materials for oncology medicines. Shapsha anticipated competitive production and improved drug safety. The announcement did not specify the investment budget or a construction timetable.

Pharmasyntez company identity

Manufacturing stages and quality management

Active pharmaceutical ingredient manufacturing encompasses more than the production operation alone. Within the World Health Organization's 2010 good manufacturing practice guidance, the manufacturing scope includes receipt of materials and the controls accompanying their movement through the production chain. It also covers the following operations:

Production and quality control.
Packaging, repackaging, labelling and relabelling.
Release, storage and distribution of ingredients.

The guidance connects these activities to an appropriate quality-management system and the quality and purity represented for the ingredients. Its recommendations allow alternatives that demonstrate at least equivalent quality assurance, as well as exceptions where a recommendation is inapplicable. The terms current good manufacturing practices and good manufacturing practices have equivalent meanings within that guidance. This is general manufacturing context; the Kaluga agreement does not announce WHO certification of the planned plant.

Pharmaceutical ingredient quality control

The manufacturing partners

BDR Pharmaceuticals was founded in 2003. It develops and produces medicines and active pharmaceutical ingredients, with four specialist segments: oncology, critical care, gynecology and neurology.

Pharmasyntez has five plants in Ussuriysk, Irkutsk, Bratsk, Tyumen and St. Petersburg. Annual production exceeds 100 million packages. The group's parent company, JSC Pharmasyntez, is based in Irkutsk.