The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The product will be manufactured at Lupin’s facility in Goa, India.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
63-year old woman gets rare Transcatheter Tricuspid Valve Replacement (TTVR)
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
The production suspension impacts commercial and clinical trial supply
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
The product will be manufactured at Lupin’s facility in Goa, India
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