Alembic Pharma secures dual USFDA approvals for Diltiazem and Dexlansoprazole
Strengthens US portfolio with back-to-back clearances across cardiac and gastro therapies New approvals add to Alembic’s growing ANDA pipeline of ...
Tag: usfda
Alembic Pharmaceuticals announces USFDA final approval for Dasatinib Tablets
NE BUSINESS BUREAU MUMBAI, NOV 7 Alembic Pharmaceuticals Limited on Thursday announced that it has received final approval from the ...
Zydus Lifesciences secures USFDA tentative nod for Cancer Drug Olaparib Tablets
Approval covers 100 mg and 150 mg strengths; drug used in treating ovarian, breast, pancreatic and prostate cancers With this, ...
Alembic Pharma gets USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal ...
Alembic Pharma’s generic formulation to treat seizures gets USFDA final nod
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 ...
Zydus gets final nod from USFDA for Scopolamine Transdermal System 1 mg/3 days
This is the fifth ANDA approval for Zydus in the transdermal portfolio, leveraging the group’s strengths in the manufacturing of ...
Zydus Lifesciences gets USFDA nod for marketing generic Parkinson’s drug
Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg Eligible for ...
Q1FY25 results: Zydus Lifesciences net profit rises 31% to Rs 1,420 cr
Company receives USFDA approval for Valbenazine Capsules Revenue from operations at Rs. 62,075 mn, up 21% YoY Research & Development ...
Alembic Pharmaceuticals receives 6 USFDA approvals during Q2FY24
NE BUSINESS BUREAU MUMBAI, OCT 4 Alembic Pharmaceuticals Limited on Wednesday announced that it has received US Food & Drug ...
Cadila Pharmaceuticals Dholka facility again passes USFDA audit
Clearing the USFDA audit with nil 483 observations means Cadila Pharmaceuticals can continue to export its high-quality medicines made at ...
