Latest news and insights on the pharmaceutical industry | Indian Pharma Post

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

375 News Found

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


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


Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension
Drug Approval | April 12, 2025

Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension

Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


OneSource Specialty Pharma updates on cGMP inspection by USFDA
Drug Approval | April 01, 2025

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations


Briefs: Alembic Pharmaceuticals and Shelter Pharma
News | March 24, 2025

Briefs: Alembic Pharmaceuticals and Shelter Pharma

Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility


Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg
Drug Approval | March 19, 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer


Lupin receives tentative approval from USFDA for Amifampridine Tablets
Drug Approval | March 18, 2025

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.