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 Limited Expands Hepatitis C Licensing Agreement with Gilead Sciences Inc. to Include Investigational Pan-Genotypic Agent
Jan 26 15
Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences Inc. to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir(Sovaldi®)/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that the company entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. The company also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
Mylan to Supply ARV Medications to South African National Department of Health
Dec 31 14
Mylan Inc. revealed that its subsidiary in India, Mylan Laboratories Ltd. has been selected as a supplier of ARV medications to the South African National Department of Health. The supply agreement was made through Mylan's South African-based subsidiary Mylan (Proprietary) Limited and covers the tender period 1 April 2015 to 31 March 2018. Mylan will supply the South African Government with triple therapy fixed dose combination (FDC) treatments.
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.
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