Manufacturing Enterprise "Academpharm"

https://academpharm.by/  
220141 Minsk, Academician Kuprevich str. 5/3

The drug Viradej (Emtricitabine, Tenofovir disoproxil and Efavirenz)

COUNTRY OF ORIGIN

Belarus

IDENTIFIER

BO6851

PUBLISHED

2023-05-14

LAST UPDATE

2023-05-18

DEADLINE

Linked profile in other language
Responsible
Natalia Safronova
+375 17 268 6364
production@academpharm.by
Summary
The manufacturing enterprise "Academpharm" offers consumers Viradej (Emtricitabine, Tenofovir disoproxil and Efavirenz), a drug for the treatment of infection caused by the human immunodeficiency virus type 1 under a manufacturing agreement and is looking for partners to conclude a distribution services agreement.
Description
International nonproprietary name: Emtricitabine, Tenofovir disoproxil and Efavirenz.
Pharmacotherapeutic group - Antiviral agents for systemic use. Combinations of antiviral drugs for the treatment of HIV infection.

Viraday is a fixed dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate. The drug is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults aged 18 years and older with HIV-1 RNA virological suppression levels < 50 copies/mL when receiving combination antiretroviral therapy for over three months. Patients must have no virological failure on any prior antiretroviral therapy and must be shown to be free of viral strains with mutations conferring marked resistance to each of the three components of Viraday prior to starting their first course of antiretroviral therapy.

There are currently no data from clinical studies with a fixed combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate in previously untreated patients or in patients with no data to support the combination of a fixed combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate with other antiretrovirals.

The characteristics of the drug, instructions for patients and specialists can be found here (in Russian).
Advantages and Innovations
A medicinal product for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults aged 18+ years with HIV-1 RNA virological suppression levels < 50 copies/mL when receiving combination antiretroviral therapy for more than three months.
Stage of development
Already on the market
Funding source
State budged
Internal
IPR status
Exclusive rights
Secret know-how
Sector group
BioChemTech
Healthcare

Client information

Type
R&D institution
Year established
2009
NACE keywords
C.21.10 - Manufacture of basic pharmaceutical products
C.21.20 - Manufacture of pharmaceutical preparations
M.72.11 - Research and experimental development on biotechnology
M.74.90 - Other professional, scientific and technical activities n.e.c.
Q.86.90 - Other human health activities
Turnover (in EUR)
10-20M
Already engaged in transnational cooperation
Yes
Additional comments
ACADEMPHARM is a dynamically developing science-intensive state pharmaceutical enterprise.
Activities:
- laboratory pharmaceutical research;
- industrial production of medicines and other pharmaceutical products, vitamin, vitamin-mineral and metabolic complexes, nutraceuticals;
- contract pharmaceutical production.

The state enterprise "AKADEMPHARM" has national certificates of GMP (good manufacturing practice) for the production of all forms of output of its own products.

The company has implemented and operates a pharmaceutical quality system developed in accordance with the requirements of national standards TKP 030-2017 (33050) "good manufacturing practice" and international requirements.

The pharmaceutical quality system includes good manufacturing practice, quality control and quality risk management, is fully documented and its effectiveness is monitored. All parts of the quality system are provided with competent personnel, a sufficient number of appropriate premises, equipment and facilities.

As part of the quality system, the enterprise has a quality assurance department and a quality control department, including:
- physical and chemical laboratory;
- microbiological laboratory;
- group of controllers.

The quality control department of the enterprise is accredited for compliance with GOST ISO / IEC 17025-2019.
Attestat_18.09.2020-pdf-min (2)

A multi-stage quality control system ensures incoming control of raw materials and materials, control of the production process and quality control of manufactured medicines.

Modern laboratory equipment, methods used, validation of quality control methods and production processes, as well as high professionalism of specialists guarantee the quality of products.

Further control of products is carried out during the entire shelf life of archival medicinal products of any series. Functioning system for drug safety monitoring and pharmacovigilance.

The state enterprise "AKADEMPHARM" guarantees the conformity of the manufactured products to their purpose and the requirements of registration documents, minimizing the risks for patients associated with the safety, quality and efficacy of manufactured medicines.
Languages spoken
English
Russian

Information about partnership

Type of partnership considered
Distribution services agreement
Manufacturing agreement
Type and role of partner sought
Consumers interested in purchasing Viraday for the treatment of human immunodeficiency virus type 1 infection under a manufacturing agreement.

Partners interested in purchasing Viraday for the treatment of human immunodeficiency virus type 1 infection under a distribution services agreement.
Type and size of partner sought
> 500
251-500
SME 51-250
SME 11-50
SME <= 10
R&D Institution
University

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