Manufactur standard Apixaban Supplier - Bictegravir 1611493-60-7 – CPF

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Manufactur standard Apixaban Supplier - Bictegravir 1611493-60-7 – CPF Detail:

Description

Bictegravir is a novel, potent inhibitor of HIV-1 integrase with an IC50 of 7.5 nM.

In Vitro

Bictegravir (BIC) inhibits the strand transfer activity with an IC50 of 7.5± 0.3 nM. Relative to its inhibition of strand transfer activity, Bictegravir is a much weaker inhibitor of 3′-processing activity of HIV-1 IN, with an IC50 of 241±51 nM. Bictegravir enhances the accumulation of 2-LTR circles ~5-fold relative to the mock-treated control and reduces the amount of authentic integration products in infected cells by 100-fold. Bictegravir potently inhibits HIV-1 replication in both MT-2 and MT-4 cells with EC50s of 1.5 and 2.4 nM, respectively. Bictegravir exhibits potent antiviral effects in both primary CD4+ T lymphocytes and monocyte-derived macrophages, with EC50s of 1.5±0.3 nM and 6.6±4.1 nM, respectively, which are comparable to values obtained in T-cell lines[1].

MCE has not independently confirmed the accuracy of these methods. They are for reference only.

NCT Number Sponsor Condition Start Date

Phase

NCT03998176 University of Nebraska|Gilead Sciences HIV-1-infection October 9, 2019

Phase 4

NCT03789968 Thomas Jefferson University|University of Maryland, College Park|Indiana University Health|The Brooklyn Hospital Center|University of Illinois at Chicago|Nova Southeastern University|University of California, San Francisco HIV+AIDS September 1, 2019
NCT04249037 University of Colorado, Denver|Gilead Sciences HIV+AIDS March 1, 2020

Not Applicable

NCT04132674 Vancouver Infectious Diseases Centre Human Immunodeficiency Virus I Infection|Drug Use November 26, 2018

Phase 4

NCT04054089 Cristina Mussini|University of Modena and Reggio Emilia HIV Infections September 2019

Phase 4

NCT04155554 Azienda Ospedaliera Universitaria Senese|Catholic University of the Sacred Heart|Ospedale Policlinico San Martino|Azienda Ospedaliera San Paolo|Ospedale Amedeo di Savoia HIV-1-infection January 29, 2020

Phase 3

NCT02275065 Gilead Sciences HIV-1 Infection October 2014

Phase 1

NCT03711253 University of Southern California Acute HIV Infection October 14, 2019

Phase 4

NCT02400307 Gilead Sciences HIV April 17, 2015

Phase 1

NCT03499483 Fenway Community Health HIV Prevention January 24, 2019

Phase 4

NCT03502005 Midland Research Group, Inc.|Gilead Sciences Human Immunodeficiency Virus March 1, 2018

Phase 4

Chemical structure

Bictegravir-1611493-60-7

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

OUR STRENGTH

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.


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  • The manufacturer gave us a big discount under the premise of ensuring the quality of products, thank you very much, we will select this company again.
    5 Stars By Murray from Macedonia - 2018.06.18 17:25
    The goods we received and the sample sales staff display to us have the same quality, it is really a creditable manufacturer.
    5 Stars By Mary from Zambia - 2018.10.01 14:14
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