Drug Approval | September 30, 2023
Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
Mankind Pharma commences the commercial operations newly set-up plant in Udaipur
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
The companies will work with investigators to share the results with the scientific community
Clindamycin Phosphate Gel is used to treat acne
InvaGen has received 5 inspectional observations in Form 483
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
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