OneSource receives USFDA EIR with VAI Classification for its SPD facility in Bengaluru
The development adds to OneSource’s regulatory track record as it continues to build a differentiated globally competitive CDMO…
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Browsing Tag
USFDA
Gland Pharma’s Visakhapatnam facilities clear USFDA inspection with zero observations
The inspection was conducted from August 24 to September 1, 2026
Zydus gets final US FDA approval for Ascorbic Acid Injection with 180-Days CGT exclusivity
The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for…
Alembic Pharma announces partner NATCO Pharma gets USFDA tentative nod for Olaparib tablets
Alembic will distribute the product in the US, and its partner NATCO will manufacture Olaparib Tablets, 100 mg and 150 mg
Alembic Pharmaceuticals gets USFDA approval for Dapsone Gel, 5%
Dapsone Gel is indicated for the topical treatment of acne vulgaris
Lupin gets tentative nod from US FDA for Enzalutamide tablets
The tentative approval covers the 40 mg, 80 mg, 120 mg, and 160 mg strengths
USFDA and EUDRA dashboards offer lessons for strengthening India’s regulatory transparency
Milind Sathe analyses how public regulatory dashboards can support pharmaceutical innovation, compliance and patient safety in…
Zydus to acquire Assertio in all-cash tender offer
Assertio is focused on specialty and oncology supportive-care therapies
Lupin gets US FDA nod for Famotidine Injection, USP
This product would be manufactured at Lupin’s Nagpur facility in India
Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Cevimeline…