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Results For "Food-and-Drug-Administration"

1018 News Found

Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System
Drug Approval | September 16, 2023

Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States


Bajaj Healthcare announces receipt of EIR from USFDA
Drug Approval | September 14, 2023

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Insmed announces positive results from Phase III arise study of ARIKAYCE
News | September 06, 2023

Insmed announces positive results from Phase III arise study of ARIKAYCE

Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


Zydus receives final USFDA approval for Erythromycin Tablets
Drug Approval | September 03, 2023

Zydus receives final USFDA approval for Erythromycin Tablets

Erythromycin tablets is used to prevent and treat infections in many different parts of the body


USFDA delegation visits Amneal Pharmaceutical facility in Matoda
News | September 02, 2023

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia


Lupin receives USFDA approval for Pirfenidone Capsules
Drug Approval | August 31, 2023

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US


Unichem receives ANDA approval for Prasugrel Tablets
Drug Approval | August 31, 2023

Unichem receives ANDA approval for Prasugrel Tablets

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events