Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
The company has reported total income of Rs. 4467.35 crores during the quarter ended March 31, 2023
The acquisition of Medisol is part of Lupin's strategy to expand its presence in the EU
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
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