Janssen intends to manufacture bedaquiline at the Pharmstandard plant in Ufa

| By | Drug Manufacturing, Janssen, Localization, Pharmstandard

On March 2, Janssen Pharmaceutica N.V., a part of Janssen Pharmaceutical Companies of Johnson & Johnson, signed a memorandum of intent with Pharmstandard JSC to manufacture and supply Sirturo®, a medicinal product.

The memorandum of intent was signed in order to give the Ufa Vitamin Plant of Pharmstandard JSC, one of the largest manufacturers of pharmaceuticals in Russia, the status of Janssen’s Sirturo® (bedaquiline) manufacturer. This drug is used for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. It is expected that collaboration will provide additional capacity for the production of bedaquiline.

It will also expand the existing partnership between Janssen and Pharmstandard JSC. According to the terms of license agreement signed in 2012, Janssen granted to Pharmstandard JSC the commercial rights to bedaquiline used for the treatment of MDR-TB in the Russian Federation and a number of countries in the Commonwealth of Independent States (CIS), Eastern Europe, and Asia. In addition, Janssen transferred to Pharmstandard JSC technology and know-how for manufacturing bedaquiline. In 2013, Pharmstandard JSC became the holder of registration certificate for bedaquiline in Russia.

“We are proud to expand our partnership with Pharmstandard JSC, which will ultimately allow more patients with MDR-TB around the world to get access to bedaquiline,” said Dr. Paul Stoffels, Chief Scientific Officer, Johnson & Johnson.

SOURCE: gmpnews.ru
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