Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling
The system is powered by BrainSense technology, which has received approval from USFDA
Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions
Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery
Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.
This inspection is now closed
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