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723 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


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


Strides completes EU GMP inspection at Puducherry facility
News | June 29, 2021

Strides completes EU GMP inspection at Puducherry facility

The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection


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


Cipla receives final approval for generic version of Brovana
News | June 24, 2021

Cipla receives final approval for generic version of Brovana

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana