Drug Approval | September 05, 2023
Caplin Steriles receives EIR from US FDA
The inspection classification was determined by the agency as Voluntary Action Indicated
The inspection classification was determined by the agency as Voluntary Action Indicated
CMOs showed an increasing reluctance to take on debt in 2022
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
The acquisition of Medisol is part of Lupin's strategy to expand its presence in the EU
The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m
Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers
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