USFDA completes PAD E inspection of Marksans' Goa facility
The inspection was conducted at its Goa, Vema manufacturing facility
The inspection was conducted at its Goa, Vema manufacturing facility
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
The inspection closed with zero observations and a classification of No Action Indicated
The product is being launched in August 2023
Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
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 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
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