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Results For "USA"

902 News Found

USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval | November 21, 2022

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited


Apollo launches national program to promote rational use of antibiotics
News | November 18, 2022

Apollo launches national program to promote rational use of antibiotics

Program will fight the rising incidence of antimicrobial (drug) resistance and improve patient outcomes


IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr
News | November 15, 2022

IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr

The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA


Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP
Drug Approval | November 15, 2022

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.


Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Ami Organics Q2 FY23 revenue up 20.2%; Profit up 9%
News | November 08, 2022

Ami Organics Q2 FY23 revenue up 20.2%; Profit up 9%

The company has successfully developed Methyl salicylate using Flow Chemistry and successfully erected a Flow reactor at Jhagadia plant and expects to start production from Q3 FY23


Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


Zydus Announces New Data Presentations at The Liver Meeting 2022
News | November 04, 2022

Zydus Announces New Data Presentations at The Liver Meeting 2022

Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis