SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure

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

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.

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections

UFlex secures USFDA approval for recycled PE in food packaging

Announces Rs. 317 crore investment in new recycling plant

Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff

Zydus receives final approval from USFDA for Dasatinib Tablets

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase