Celltrion Inc., a Korea-based global pharmaceutical company, is a pioneer in a biosimilar field that has proved to be prominent in the manufacturing and distribution of biopharmaceuticals as well as chemical drugs. More than 200 products of Celltrion have obtained product approval by Korea’s Ministry of Food and Drug Safety (MFDS).
The company has recently established a state-of-the-art cGMP- compliant manufacturing facility whose manufacturing capacity is up to 10 billion tablets annually. Currently, Celltrion is maintaining US/EU, PIC/s, ICH GMP standard quality systems and cGMP-designed facilities. Together with these global quality control systems, production capacity has grown to up to 10 billion tablets per year.
Linezolid is an antibiotic used for the infections caused by gram-positive bacteria, such as pneumonia, sepsis (bacterial infection in the bloodstream), skin and skinstructure infections. It is one of the strongest antibiotics, and is especially prescribed for patients with MethicillinResistant Staphylococcus Aureus (MRSA). Also, Linezolid is used as essential second-line tuberculosis treatment, as it is listed in the 2016 WHO guidelines for the core second-line treatment of tuberculosis. It is specifically useful for the MDR/XDR-TB (Multi Drug Resistant / Extensive Drug Resistant) patients since Linezolid is effective for the many patients who have resistance to other drugs. Hence, this product is highly required for the countries burdened with the aforementioned bacterial infections and tuberculosis.
Tenofovir Disoproxil fumarate and Lamivudine dualcombination tablets are more affordable and clinically equivalent versions of Truvada, the mainstay of 1st-line HIV treatment antiretroviral medicines. In our products, lamivudine replaces the emtricitabine (in Truvada), since lamivudine is considered as equivalent in terms of clinical effectiveness.
TLE triple- combination tablets are more affordable and clinically equivalent versions of Atripla, the mainstay of 1st-line HIV treatment antiretroviral medicines. In our products, lamivudine replaces the emtricitabine (in Atripla) since lamivudine is considered as equivalent in terms of clinical effectiveness.
TLE is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. It should be administered, one tablet per day. The fact that TLE covers the highest portion in international HIV medicines procurement (it is strongly recommended in WHO 2016 guideline – as the most preferred 1st line anti-retroviral treatment) proves its effectiveness and price competitiveness.
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