Biocom
RusEng
THE FLEXIBLE MODULAR PHARMACEUTICAL MANUFACTURE CERTIFIED
FOR THE INTERNATIONAL QUALITY STANDARD GMP
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Participation in WHO Prequalification Program

As a part of MDR-TB Partnership which was organized by the leading pharmaceutical manufacturer “Eli Lilly”, JSC “Biocom” received the original manufacturing technology for the antibiotic agent “Cycloserine capsules 250 mg №100” on a free-of-charge basis.

In 2008, JSC “Biocom” registred the finished product named Cycloserine in Russia and a year later received the manufacturing license for it.
In November 2008, JSC “Biocom” began work on the preparation of dossier in accordance with the requirements of the World Health Organization (WHO) to participate in the Prequalification Program with the finished product “Cycloserine capsules 250 mg”.
In November 2009 the dossier was handed in to the Prequalification Program of WHO. Over the period of 2010-2012, JSC “Biocom” underwent two audits with respect to compliance with the requirements of GMP.
In August 2013, JSC “Biocom” was included into the list of approved manufacturers of WHO.
Therefore, JSC “Biocom” became the first and so far the only Russian pharmaceutical manufacturer which passed the Prequalification Program of WHO and got approved by it.
In September 2014, the company “Eli Lilly” organized the press tour to the manufacturing site of JSC “Biocom”. At the press conference during this visit all the details of interaction of the company “Eli Lilly” and JSC “Biocom”, including manufacturing technology transfer and the experience of JSC “Biocom” in the Prequalification Program by WHO, were fully covered.

We offer you the film about the partnership between JSC “Biocom” and “Eli Lilly”.
 

 
Fluconazole 50 mg
54 Chapaevsky Cr., Stavropol, 355016, Russian Federation
tel.: +7-8652-365356, fax: +7-8652-365355
E-mail: biocom@biocom.ru