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8342 News Found

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets
News | July 09, 2021

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets

The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA


Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil
News | July 04, 2021

Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil

The drug is used with other HIV medications to help control HIV infection and it helps to decrease the amount of HIV in one’s body so that the immune system can work better


Zydus applies to the DCGI for EUA to launch ZyCoV-D
News | July 01, 2021

Zydus applies to the DCGI for EUA to launch ZyCoV-D

ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials


Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets
News | July 01, 2021

Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets

TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg


Lonza to expand API manufacturing facility in Nansha, China
News | June 28, 2021

Lonza to expand API manufacturing facility in Nansha, China

The expanded laboratories and manufacturing facilities at Nansha are expected to come online between Q1 2022 and Q3 2022


Zydus Cadila receives tentative approval from USFDA for Pemetrexed
News | June 26, 2021

Zydus Cadila receives tentative approval from USFDA for Pemetrexed

Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells


Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion


Shilpa Medicare receives DRDO approval for 2DG manufacturing
News | June 26, 2021

Shilpa Medicare receives DRDO approval for 2DG manufacturing

2DG has been given emergency approval by the Drug Controller General of India for COVID-19 patients in the country


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis


Poxel and Sumitomo Dainippon gets TWYMEEG approval
News | June 25, 2021

Poxel and Sumitomo Dainippon gets TWYMEEG approval

The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies