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Results For "USFDA"

1123 News Found

Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat
Drug Approval | April 29, 2025

Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat

The inspection concluded with 6 observations and none of them were related to Data Integrity


Lupin receives USFDA approval for Tolvaptan Tablets
Drug Approval | April 24, 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Drug Approval | April 24, 2025

Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K


Eugia Pharma receives USFDA approval for Dasatinib Tablets
Drug Approval | April 24, 2025

Eugia Pharma receives USFDA approval for Dasatinib Tablets

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia


Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg
Drug Approval | April 17, 2025

Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA


Lupin receives EIR from USFDA for its injectable facility in Nagpur
Drug Approval | April 17, 2025

Lupin receives EIR from USFDA for its injectable facility in Nagpur

The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024


Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg
News | April 16, 2025

Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg

The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older


Nureca’s manufacturing subsidiary secures USFDA registration
News | April 14, 2025

Nureca’s manufacturing subsidiary secures USFDA registration

This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States


Aurolife Pharma gets 11 observations from USFDA for Raleigh plant
Drug Approval | April 14, 2025

Aurolife Pharma gets 11 observations from USFDA for Raleigh plant

The company does not expect this development to have any material impact on the current business operations