News | December 14, 2021
Lupin’s Goa plant receives EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated
FDA changes inspection classification of the facility to Voluntary Action Indicated
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
The product will be commercialized from Unichem's Ghaziabad plant
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The injection is used to reverse the effects of the muscle relaxants given to patients during surgery
This product will be manufactured at Lupin’s Pithampur facility In India
Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
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