Hetero launches one of the India’s largest finished dosage manufacturing facility in Special Economic Zone (SEZ) at Jadcherla.
Hetero launches its new formulations facility (SEZ) at Jadcherla, Andhra Pradesh, India. Strategically located just 60 kms from Hyderabad International airport, off NH 7, the project situated in the state's first green industrial park.
The total unit area is 75 acres and with two manufacturing facilities. This facility offers a huge production capacity of 18 billion tablets and capsules per annum. It has a dedicated Oncology facility with a production capacity of 200 million tablets & capsules, 15 million liquid injectable vials & 15 million lyophilised Injectables.
This World-class facility is meeting the cGMP and regulatory requirements, with integrated quality management system in place. All quality control Instruments are 21-CFR compliant. Walk in type stability chambers with global requirements for stability study and Integrated building management system from Honey well -USA , Lyophilizer VIRTIS -USA, Liquid Filling machine from BOSCH – Germany, makes this manufacturing facility at par with the best in the world.
Hetero receives tentative approval for Tenofovir disoproxil fumarate tablets from USFDA
Hetero is pleased to announce that it has received the tentatively approval for Tenofovir disoproxil fumarate from the US Food & Drug Administration (USFDA).
Tenofovir tablets 300 mg is generic equivalent to Viread tablets 300 mg of Gilead Sciences. Tenofovir belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
Hetero receives tentative approval of Lamivudine and Tenofovir fixed dose combination tablets, 300mg/300mg tablets from USFDA
On November 5, 2009, using expedited review procedures developed to support the President's Emergency Program For AIDS Relief (PEPFAR1), the US Food and Drug Administration (FDA), granted tentative approval for lamivudine and tenofovir disoproxil fumarate fixed dose combination tablets, 300mg/300mg.
The fixed dose combination product, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection.