Tag
USFDA
3 articles
Marksans Pharma Gets USFDA Approval Benzonatate Capsules
Marksans Pharma received final USFDA approval for its ANDA for Benzonatate Capsules USP, 100 mg & 200 mg (Rx).
The product is bioequivalent to Pfizer's Tessalon Capsules and treats persistent cough, b
Granules Life Sciences Gets US FDA VAI Classification
Granules Life Sciences Private Limited (GLS), a wholly owned subsidiary of Granules India, received VAI classification from US FDA for its Shamirpet, Telangana facility.
The Establishment Inspection R
Alembic Pharma Gets USFDA Approval Paroxetine ER Tablets
Alembic Pharmaceuticals received USFDA final approval for Paroxetine Extended-Release Tablets USP, 12.5 mg on 27th March 2026.
The approved sANDA is therapeutically equivalent to Paxil CR Tablets 12.5