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Results For "USFDA-approval"

194 News Found

Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries
News | August 17, 2023

Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries

Aurobindo's product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon


Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval | May 03, 2023

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment


Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma
Drug Approval | January 05, 2023

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.


Zydus receives final approval from USFDA for Lenalidomide Capsules
Drug Approval | September 15, 2022

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


My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape
interviews | May 23, 2022

My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape

Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com


USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
Drug Approval | May 01, 2022

USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis

The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases


USFDA clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope


Launches and margin sustainability hold key for Glenmark: ICICI Direct
News | February 15, 2022

Launches and margin sustainability hold key for Glenmark: ICICI Direct

Key takeaways of Q3FY22 quarter & conference call highlights