Manufacturing Enterprise "Academpharm"

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

The drug Febuxostat-NAN

COUNTRY OF ORIGIN

IDENTIFIER

BO6852

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 the drug Febuxostat-NAN for the treatment of gout under a manufacturing agreement and is looking for partners to conclude a distribution services agreement.
Description
International non-proprietary name: Febuxostat.
Febuxostat-NAN tablets contain the active ingredient febuxostat and are used to treat gout, a disease associated with excessive accumulation of uric acid (urates) in the body. Some people have too much uric acid in their blood, making it insoluble. As a result, urate crystals can form, deposited in the joints and kidneys. This process may be accompanied by sudden severe pain, redness, swelling and fever of the joint (gout attack). Left untreated, individual crystals form large clusters (tophi) in and around the joints. These tophi can destroy the joint and bone.

Febuxostat-NAN reduces the level of uric acid. Against the background of daily intake of Febuxostat-NAN, the concentration of uric acid remains low enough to prevent the formation of crystals and, over time, helps to reduce the severity of the symptoms of the disease. If the concentration of uric acid remains low for a long time, then the size of the tophi may also decrease.

Febuxostat-NAN 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood, which can occur at the beginning of chemotherapy for malignant blood diseases.

During chemotherapy, tumor cells are destroyed, causing an increase in the concentration of uric acid in the blood, if uric acid formation has not been prevented.

Febuxostat-NAN is intended for use in adults.

The characteristics of the drug, instructions for patients and specialists can be found here (in Russian).
Advantages and Innovations
- Febuxostat is more effective than allopurinol in reaching uric acid targets.
- No significant drug interactions.
- There is no need for dose adjustment in patients with mild to moderate renal impairment.
Stage of development
Already on the market
Funding source
State budged
Internal
IPR status
Exclusive rights
Secret know-how
Sector group
BioChemTech
Healthcare

Organization 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 Febuxostat-NAN for the treatment of gout under a manufacturing agreement.

Partners interested in purchasing Febuxostat-NAN for the treatment of gout 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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