USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

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

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

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

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

Orchid Pharma Q2 FY25 PAT up 26% YoY driven by strategic initiatives for market expansion

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

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

Lupin receives tentative approval from USFDA for Raltegravir Tablets

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

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

Lonza’s Synaffix collaborates with BigHat Biosciences for ML-designed ADC

Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies