Drug Approval | October 03, 2022
Lupin gets EIR from USFDA for its Ankleshwar facility
The inspection of the facility was conducted from August 16-19, 2022.
The inspection of the facility was conducted from August 16-19, 2022.
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
The company will address the observations within a stipulated timeline working with the regulators
Lenalidomide is used to treat various types of cancers.
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
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Veda Corporate Advisors was the exclusive financial advisor to SHPL and its shareholders.
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
This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform
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
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