USFDA accepts biologics license application for GC Biopharma's GC5107B

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023

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

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India

Boehringer Ingelheim receives FDA approval for NexGard Plus

The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial

Novartis acquires DTx Pharma to develop siRNA therapies

Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications