Combination creates a leading, next generation claims operating system for payers, with end-to-end AI capabilities for claims, payments, care & utilization management, payment integrity, and member engagement, serving 115+ health plans
Kenox to provide formulation and development expertise in orally inhaled and nasal drug products
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Agreement further expands Aptar Pharma’s leading position in nasal delivery solutions and addresses significant unmet needs of delivering drugs locally over extended periods
The company has received approval from DCGI to begin patient enrolment and dosing in the country
PendraCare Group develops, manufactures and sells innovative cardiology catheter solutions and provides design, development and manufacturing services to other global OEM’s
It will focus on interface between API and formulation manufacturing, reducing carbon footprint in formulation production, creating intellectual property, training next-generation scientists, and setting new industry benchmarks
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
The U.S. FDA issued a Form 483 with five observations
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