Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 165

Results For "US"

9479 News Found

USFDA accepts for priority review the sNDA for Merck’s Prevymis
Drug Approval | February 18, 2023

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients


Garuda Aerospace and Narayana Health join hands to transport biomedical supplies using drone
News | February 18, 2023

Garuda Aerospace and Narayana Health join hands to transport biomedical supplies using drone

The partnership is announced at Aero India 2023, Bangalore


Lupin receives EIR from USFDA for injectable facility in Nagpur
News | February 18, 2023

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022


Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Zydus receives tentative approval from the USFDA for Canagliflozin tablets
Drug Approval | February 16, 2023

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya


Aurobindo Pharma gets VAI classification from USFDA for Telangana plant
News | February 16, 2023

Aurobindo Pharma gets VAI classification from USFDA for Telangana plant

Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated


Thermo Fisher Scientific launches real-time PCR kits for detection of infectious diseases in India
Medical Device | February 15, 2023

Thermo Fisher Scientific launches real-time PCR kits for detection of infectious diseases in India

The Applied Biosystems TaqPath PCR kits have been analytically- and clinically-validated for use in patient care


NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product