Company Overview of Mylan Laboratories Limited
Mylan Laboratories Limited engages in the manufacture and supply of active pharmaceutical ingredients (APIs) in India and internationally. It offers its products in various therapeutic categories, including anti-bacterials, central nervous system (CNS) agents, antihistamine/anti-asthmatics, cardiovascular, anti-virals, anti-diabetics, anti-fungals, proton pump inhibitors, and pain management drugs. The company also maintains a portfolio of finished dosage forms of generic antiretroviral products used for the treatment of HIV/AIDS, including pediatric therapies. In addition, Mylan Laboratories offers contract research and development services during early stages of development and contract ma...
Plot No. 564/A/22
Road No. 92
Founded in 2001
Key Executives for Mylan Laboratories Limited
Head of Finance and Senior Vice President
Compensation as of Fiscal Year 2014.
Mylan Laboratories Limited Key Developments
Mylan Laboratories Receives Tentative FDA Approval for Paediatric Formulations of Abacavir/Lamivudine Through Innovative Collaboration with Viiv Healthcare and Clinton Health Access Initiative
Dec 4 14
Mylan Inc. announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavoured. The FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) programme means the formulations meet all of the agency's quality, safety and efficacy standards. The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan's products are expected to be eligible for purchase in early 2015. The fixed dose combination of abacavir and lamivudine tablets for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for paediatric patients. More than 70% of the approximately 3.4 million children living with HIV worldwide do not have access to appropriate care and medicines . Improving those numbers will require medicines that are palatable to children and affordable to those living in resource-limited settings.
Mylan Laboratories Limited Signs Deal with Gilead Sciences Inc. to Enhance Access to TAF-Based HIV Treatments
Dec 1 14
Mylan Laboratories Limited has entered into an agreement with Gilead Sciences Inc. (GILD) under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide or TAF as both a single agent product and in combination with other drugs. Tenofovir Alafenamide or TAF is an investigational antiretroviral drug for the treatment of HIV-1 infection. The license being granted to Mylan extends to 112 countries, which together account for more than 30 million people living with HIV, representing 84% of those infected globally. As part of the licensing deal, on U.S. Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of Tenofovir Alafenamide (TAF), if approved as a single agent or in approved combinations containing Tenofovir Alafenamide (TAF) for developing markets.
Mylan Laboratories Enters into an Agreement with Gilead Sciences, Inc
Sep 15 14
Mylan Inc. announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences Inc. under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi(R). The countries within the agreement account for more than 100 million people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
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