Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 23

Results For "U.S.-FDA"

291 News Found

Lupin receives approval from USFDA for Darunavir Tablets
Drug Approval | October 05, 2022

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Pfizer announces positive results from Phase 3 study of 20-valent pneumococcal conjugate vaccine
Clinical Trials | August 13, 2022

Pfizer announces positive results from Phase 3 study of 20-valent pneumococcal conjugate vaccine

Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr
News | August 04, 2022

Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr

Lupin is the 6th largest company in the Indian Pharmaceutical Market


USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility
News | July 04, 2022

USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.


Glenmark Pharmaceuticals expand its OTC portfolio
News | June 29, 2022

Glenmark Pharmaceuticals expand its OTC portfolio

The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi