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Results For "USFDA"

1130 News Found

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
News | December 15, 2022

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.


US Federal Court dismisses cancer linkage associated with Zantac
News | December 13, 2022

US Federal Court dismisses cancer linkage associated with Zantac

The current ruling will assure the safety of the use of Ranitidine for Indian patients


Alembic receives EIR for oncology injectable formulation facility at Panelav
Drug Approval | December 12, 2022

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA


BASF Pharma Solutions excipient accepted into FDA Pilot Program
Drug Approval | December 06, 2022

BASF Pharma Solutions excipient accepted into FDA Pilot Program

Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Orchid Pharma launches Rs. 500 Cr QIP programme
News | December 02, 2022

Orchid Pharma launches Rs. 500 Cr QIP programme

With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".


Laurus Labs takes stake in Ethan Energy India
News | November 25, 2022

Laurus Labs takes stake in Ethan Energy India

This will enable the company to consume 100% of the solar energy to be supplied by Ethan Energy India Private Limited from their 10 MW Solar Energy plant


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)