News | August 29, 2022
Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
With the receipt of the EIR, the inspection stands successfully closed.
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
Collaboration supports multiple discovery efforts, including vaccines
The company has reported total income of Rs. 70.59 crores during the period ended June 30, 2022.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The company has reported total income of Rs. 65.19 crores during the period ended June 30, 2022.
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