Lupin receives approval from US FDA for Prucalopride Tablets
The approved tablets are bioequivalent to Takeda’s Motegrity and will be manufactured at Lupin’s Goa facility
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Drug approvals
Alembic Pharmaceuticals receives USFDA EIR for API-III facility in Gujarat
The inspection at the Karakhadi-based manufacturing site was conducted by the USFDA from 17 to 21 March 2025
Lupin receives tentative US FDA approval for Oxcarbazepine ER tablets
Oxcarbazepine extended-release tablets to be manufactured at Lupin’s Nagpur facility for US market
Gland Pharma receives USFDA approval for Angiotensin II Acetate injection
Gland Pharma secures 180-day exclusivity for Angiotensin II Acetate Injection following USFDA approval
Zydus secures tentative USFDA approval for Rifaximin Tablets 550 mg
The tablets, used for treating IBS-D in adults, will be manufactured at the company’s SEZ II facility in Ahmedabad
AstraZeneca India gets CDSCO approval for additional indication for Osimertinib in unresectable…
The approval follows evidence from the Phase III LAURA trial, which demonstrated significant clinical benefits in delaying disease…
Alembic gains USFDA final approval for Amlodipine & Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5…
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, of Pharmacia and…
Indoco Remedies gains USFDA final approval for Allopurinol Tablets USP 200 mg
Allopurinol prevents or lowers high uric acid levels caused by cancer medicines or in patients with kidney stones
Lupin gains USFDA approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg
Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals
Lupin launches Tolvaptan Tablets in the US
Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity
Lupin gains USFDA nod for Raltegravir Tablets USP, 600 mg
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
AstraZeneca’s Trastuzumab deruxtecan therapy receives CDSCO nod to manage HER2- low & ultra-low…
The medicine is now indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic breast cancer
FDA approves trial to advance treatment for Hereditary Spastic Paraplegia (HSP)
The trial will be conducted in the United States at Boston Children’s Hospital and will assess the safety, tolerability, and…
Strides Pharma receives USFDA approval for Celecoxib Capsules in multiple strengths
Approval from USFDA allows Strides Pharma to market Celecoxib Capsules 100 mg, 200 mg, and 400 mg in the United States
Alembic Pharmaceuticals receives US FDA EIR for Panelav oncology facility
US FDA inspection for injectable and oral solid formulation unit conducted in October 2024 has been successfully closed
ENTOD Pharmaceuticals receives CDSCO approval for paediatric myopia treatment
The formulation, approved following Phase 3 trials in India, becomes the first globally authorised treatment strength for slowing…
Lupin receives US FDA approval for generic Tolvaptan Tablets
Company secures 180-day marketing exclusivity as first-to-file applicant for bioequivalent to Jynarque
Sanofi-Regeneron’s Dupixent gets FDA’s nod for skin condition
FDA clears Dupixent for chronic spontaneous urticaria in patients aged 12 and above, expanding its use in immune-related skin…
Cipla receives US FDA approval for generic version of Abraxane
Cipla secures final USFDA approval for Protein-bound Paclitaxel 100 mg/vial; launch planned in H1 FY26 in the US market
Biocon Biologics secures US FDA approval for Biosimilar Bevacizumab, JOBEVNE
The approval marks Biocon Biologics’ seventh biosimilar clearance in the US, expanding its oncology portfolio in one of the…