FDA supports new ANDA prioritization pilot to support US generic drugs

AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain

It represents a 30% increase in the company’s production capacity and introduces a segment dedicated to highly potent active ingredients

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Briefs: Panacea Biotec, Lotus Eye Hospital and Uflex

Panacea Biotec receives Rs. 315 crore LoA from UNICEF

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India

DPIIT and Thermo Fisher Scientific launch BioVerse challenge to fast-track India’s biotech future

India currently hosts more than 10,075 biotech startups