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).
The drive also conducted a mega health camp, cancer screening for women and men, ENT screening for children, and blood donation drive
With the receipt of the EIR, the inspection stands successfully closed.
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.
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
DEP® ADCs exploit the unique potential of Starpharma's DEP® technology to provide enhanced characteristics to ADCs i
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
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