Drug Approval | August 29, 2022
USFDA completes inspection at Aurolife Pharma’s Raleigh unit
The unit has filed 2 Derma products and 1 MDI product.
The unit has filed 2 Derma products and 1 MDI product.
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
There are no data integrity (DI) observations.
With the receipt of the EIR, the inspection stands successfully closed.
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
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