Supriya Lifescience receives USFDA EIR with VAI classification for Lote Parshuram facility
Inspection cycle closed following February 2026 USFDA audit
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Off label drug use and physician liability
Dr Amit Kumar, Assistant Professor of Law, Maharashtra National Law University Mumbai, examines the complex legal and ethical…
Lupin launches Dapagliflozin and Metformin extended-release tablets in the United States
USFDA approves ANDA for bioequivalent version of Xigduo XR
Zyax Chem acquires 26% stake in Gaymed Labs
Investment brings board representation and expansion plans in ophthalmic segment
OneSource and Orbicular secure USFDA tentative approval for generic semaglutide injection
Partnership progresses ANDA filing for generic version of Ozempic with manufacturing support from OneSource
India’s biopharma moment—If we get the ecosystem right
Krishna Sarma highlights the ecosystem requirements for advancing biopharma innovation in India
Morepen Laboratories clears fourth USFDA inspection at Masulkhana facility with NIL 483
Outcome follows Rs 825 crore CDMO mandate and supports global manufacturing engagements
Clinical exclusivity for indigenous medicines can improve long-term affordability and access
Nikkhil Masurkar, CEO, Entod Pharmaceuticals opines that in the absence of clinical data exclusivity, competitors may obtain…
Rusan Pharma secures PMDA GMP approval for Ankleshwar and Dehradun facilities
Approval from Japan regulator covers API and finished dosage manufacturing units
Lupin subsidiary enters settlement agreement with Humana in US antitrust litigation
Lupin Pharmaceuticals Inc to pay USD 30 million under agreement without admission of liability