USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy

USFDA accepts biologics license application for GC Biopharma's GC5107B

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr

Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma