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3810 News Found

USFDA completes PAD E inspection of Marksans' Goa facility
Drug Approval | August 09, 2023

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility


Lupin receives USFDA approval for fluocinolone acetonide body oil
Drug Approval | August 09, 2023

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)


Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma
Drug Approval | August 06, 2023

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated


Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP
Drug Approval | August 06, 2023

Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP

The product is being launched in August 2023


USFDA approves Merck’s ERVEBO for use in children 12 months of age and older
Drug Approval | August 05, 2023

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease


Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Drug Approval | August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.


Lupin receives approval from US FDA for Turqoz
Drug Approval | August 02, 2023

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)


Shilpa Medicare lunches pemetrexed injection in India under the brand name VRTU
News | August 01, 2023

Shilpa Medicare lunches pemetrexed injection in India under the brand name VRTU

Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India