Zydus receives tentative approval from USFDA for Sugammadex Injection

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery

Zydus receives final approval from USFDA for Lenalidomide Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

Zydus receives final approval from USFDA for Cariprazine Capsules

Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares

USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi

Zydus receives final approval from USFDA for two tablets

The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.