Drug Approval | August 16, 2023
Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).
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
Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
The primary purpose of this collaboration is to bring the optimized protein into the Indian market
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)
The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.
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