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.
The company shall be engaged in the business of manufacturing of pharmaceutical, bio-pharmaceutical and biological products of any kind
With the receipt of the EIR, the inspection stands successfully closed.
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
JB Pharma is the fastest growing pharmaceutical company in FY 2021-22 and Q1 of FY 2022-23.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
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