Drug Approval | October 18, 2022
Zydus receives tentative approval from USFDA for Valbenazine capsules
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
Lenalidomide is used to treat various types of cancers.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
Proceeds from the proposed issue will be utilized to part finance Balaxi’s planned EU GMP-compliant manufacturing facility for Oral Solid Dosages and Liquid Injectables at TSIIC Pharma Formulations SEZ
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
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