Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA
Approval covers multiple strengths for ADHD treatment, to be manufactured at US facility
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
ANDA approval
Alembic Pharmaceuticals receives USFDA approval for Sumatriptan single-dose autoinjector
The product marks Alembic’s first drug–device combination to be approved in the United States
Alembic Pharmaceuticals secures USFDA approval for Triamcinolone Acetonide Injectable Suspension
Alembic Pharmaceuticals highlights expansion of its US portfolio with new injectable therapy approval
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
Lupin gains USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Alembic Pharmaceuticals receive USFDA approval for Divalproex Sodium capsules
Approval marks Alembic’s 193rd final ANDA approval in the United States market
Alembic Pharmaceuticals receives U.S. FDA approval for Paliperidone extended-release tablets
Approval covers Paliperidone tablets for the treatment of schizophrenia and schizoaffective disorder
Indoco gains final ANDA approval for Lofexidine Tablets 0.18 mg
Indoco has been granted a CGT designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT…
Granules India receives ANDA approval for Glycopyrrolate Oral Solution
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz…