Alembic receives USFDA approval for Paroxetine Extended-Release tablets
Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA)…
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USFDA
Alembic Pharma gets EIR for its API – I & API – II facility located at Panelav
USFDA had carried out the inspection between May 26 – May 31, 2025
USFDA concludes cGMP audit at Cohance Lifesciences’ API manufacturing plant
Cohance Lifesciences, formerly Suven Pharmaceuticals has announced completion of a general current Good Manufacturing Practices…
Indoco Remedies gains final ANDA approval for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20…
Rivaroxaban Tablets USP will be manufactured at the company’s facility located in Goa
Alembic Pharmaceuticals gains USFDA final approval for Carbamazepine Extended-Release Tablets
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for treating pain associated with…
Zydus gains tentative approval from USFDA for Ibrutinib tablets 140 mg, 280 mg, and 420 mg
Ibrutinib tablets had annual sales of $ 2148.9 mn in the United States (IQVIA MAT May 2025)
FDA approves 127 innovator and biosimilar drugs in 2024, marks shift in pharma approval landscape
According to GlobalData, the 2024 approvals included significant milestones in the biosimilar sector, with the FDA granting…
Biocon Biologics gains USFDA approval for Kirsty, Interchangeable Rapid-Acting Insulin Aspart
KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and…
Lupin gains USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3
In this final instalment, Manish Bhatkar, Founder & CEO, RedLotus Pharmtech, transitions from analysis to action. Drawing on…