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
The inspection closed with zero observations and a classification of No Action Indicated
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
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)
Aurobindo will respond to the US FDA within the stipulated timelines
This product would be manufactured at Lupin's Nagpur facility in India
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
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