Drug Approval | July 03, 2023
Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
The company will submit its comprehensive response on these observations to the USFDA
This product will be manufactured at Lupin's Pithampur facility in India
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Subscribe To Our Newsletter & Stay Updated
