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Results For "United-States-Food-and-Drug-Administration"

378 News Found

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection
Drug Approval | May 26, 2022

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)


Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
News | May 11, 2022

Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII

The unit is an oral manufacturing facility at Jedcherla, Hyderabad


Lupin receives USFDA approval for Pregabalin and Iloperidone
Drug Approval | May 06, 2022

Lupin receives USFDA approval for Pregabalin and Iloperidone

While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility


Zydus receives tentative approval from USFDA for Selexipag tablets
Drug Approval | May 06, 2022

Zydus receives tentative approval from USFDA for Selexipag tablets

The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad


‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology
Biotech | April 25, 2022

‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology

Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia


Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
Drug Approval | April 18, 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
Drug Approval | April 15, 2022

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

The product will be manufactured at Lupin’s facility in Goa, India


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


Lupin receives approval from USFDA for Sildenafil for Oral Suspension
Drug Approval | March 24, 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

The product will be manufactured at Lupin’s facility in Goa, India