Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe

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

Meitheal acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio

Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape

dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group

dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business