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Results For "USFDA"

1355 News Found

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
News | September 14, 2023

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations


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


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


Mankind Pharma launches 120 premium DMF quality drugs for Indian Patients
News | August 30, 2023

Mankind Pharma launches 120 premium DMF quality drugs for Indian Patients

Mankind Pharma's initiative aims to ensure universal access to medicines of international calibre


Zydus to present on ZYIL1 at the International Congress of Parkinson's Disease and Movement Disorders
Clinical Trials | August 28, 2023

Zydus to present on ZYIL1 at the International Congress of Parkinson's Disease and Movement Disorders

In Phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time


Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals
Drug Approval | August 24, 2023

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat


Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences
News | August 23, 2023

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank


Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules
Drug Approval | August 22, 2023

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole


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