Russia will start producing powerful opioid analgesic from its own raw materials

Print 28 April 2018
GMP News

Russian Ministry of Health prepared a draft government decree to expand state quotas for manufacturing Remifentanil, a narcotic analgesic. The document proposes to amend the section “Narcotic Drugs” of the Annex to the Government Decree “On Approval of State Quotas for Annual Manufacturing, Storage and Importation (Exportation) of Narcotic Drugs and Psychotropic Substances.”

Previously, the annual usage of this substance was limited to 1.1 g. Current proposals provide for expanding the allowed amount to 500 g.

“The proposed state quota for Remifentanil is defined in accordance with the estimates provided by Moscow Endocrine Plant,” stated the explanatory note to the document.

The representatives of the plant confirmed that they had already started to develop a liquid form of Remifentanil. The drug launch onto the pharmaceutical market is scheduled for 2022. The first batch of the product for intravenous injection can be 10 thousand bottles.

This dosage form is required for further use in general anesthesia. Remifentanil is a synthetic opioid analgesic, which is significantly superior to morphine. The proposed quota of 500 g will be sufficient to develop the composition and manufacturing technology of the drug, obtain and test samples, and produce industrial series for state registration.

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