NANOLEK released the first batch of Hydroxychloroquine produced at its production site in the Kirov Region.
Hydroxychloroquine has been included in the COVID-19 treatment regimen in temporary guidelines of the Russian Ministry of Health for the prevention, diagnosis, and treatment of new coronavirus infection.
The first batch of this medicine has been sent to medical institutions.
“Our high-tech full-cycle production, according to GMP and ISO standards, located in the Kirov Region, allowed us to deploy the production of this drug within the shortest possible time. We have vast experience in the production of solid dosage forms (SDF). We hope that the medicine release will reduce the shortage and cover the need for this drug because there is still a need for patients with malaria and rheumatoid arthritis who have been treated with this medication for many years. Our company began the development of Hydroxychloroquine back in 2013, together with BIOCOM as a co-executor, under the state contract for the implementation of research and development work “Development of Technology and Organization of the Production of Synthetic Vital and Essential Medicine - Hydroxychloroquine not produced by domestic manufacturers and not protected by patents of foreign companies on the territory of the Russian Federation; “Code” 1.1. Hydroxychloroquine 2013”, said Mikhail Nekrasov, CEO of NANOLEK.
“The laboratory complex at BMС consists of several units: chemical-analytical, microbiological, biochemical, input control groups, finished product control, design, and control group and a monitoring group. The equipment of laboratories makes it possible to carry out quality control of any level of complexity. Currently, 123 specialists are working in the quality control department. All types of control have been passed following the data on the drug dossier; a positive conclusion was received, allowing the quality service to confirm the safety of the drug for release into circulation,” said Alexey Pavlov, Director of Quality Department, BMС NANOLEK.