Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA

Trimax Biosciences receives CEP Filing submission of Propafenone Hydrochloride from EDQM

Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%

EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24

NABH integrates FOGSI’S maternal health standards across its certification programs

The MoU signed in 2022 has progressed and culminated in the subsumption of FOGSI-led Manyata initiative’s 20 quality standards across NABH’s Certification programs

Divyesh Maru appointed CFO of Hester Biosciences

He specializes in financial planning, audit, compliance and ERP implementation, with extensive experience in leading automation and risk management projects

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

Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities

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

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan