Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

Zydus Wellness Q2 FY25 sales up 12% at Rs. 490.7 Cr

Net profit for the quarter grew by 254.2 per cent and stood at Rs. 20.9 crore

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Vimta Labs reports Q2 FY25 PAT at Rs. 17 Cr

Q2 FY25 Total Income was at Rs. 85.4 crore

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI

Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV

Company receives acceptability, in principle, for ZyVac TCV making it eligible for purchase by United Nations procurement agencies

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension