Drug Approval | August 17, 2023
Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
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).
ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity
Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive brain stimulation technique approved by regulatory authorities, including the USFDA
Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
DKSH has further fortified its strategic partnership with Biolin Scientific, a globally recognized pioneer in surface science instrumentation, across nine key markets in the APAC region
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)
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