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8877 News Found

Sun Pharma launches SEZABY in the US for treatment of neonatal seizures
News | January 27, 2023

Sun Pharma launches SEZABY in the US for treatment of neonatal seizures

SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection


USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
Drug Approval | January 24, 2023

USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa

USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


G 20: Medical Value Travel could be focused on maintaining, improving or restoring health through medical intervention: Dr V K Paul
Policy | January 21, 2023

G 20: Medical Value Travel could be focused on maintaining, improving or restoring health through medical intervention: Dr V K Paul

There is a great opportunity for utilizing traditional medical practices like Ayurveda in Value Based Healthcare


ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production
News | January 20, 2023

ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production

The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | January 19, 2023

Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes


USFDA completes inspection at APL HealthCare
Drug Approval | January 19, 2023

USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations


Lupin receives tentative approval from USFDA for Dolutegravir and Rilpivirine Tablets
Drug Approval | January 17, 2023

Lupin receives tentative approval from USFDA for Dolutegravir and Rilpivirine Tablets

Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)


USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions
Drug Approval | January 17, 2023

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22


Vikas Lifecare’s in-house R&D Unit gets DSIR recognition
News | January 17, 2023

Vikas Lifecare’s in-house R&D Unit gets DSIR recognition

This DSIR recognition for company's in-house R&D Unit make it eligible for receiving funds for R&D purpose from various government departments and agencies