USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials

Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

The product is bioequivalent and therapeutically equivalent to the reference listed drug

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India

Alembic receives USFDA’s final approval for Fluphenazine Hydrochloride Tablets

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)