Drug Approval | September 08, 2025
USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
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
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options
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 partnership, the Pfizer INDovation program will empower DPIIT-recognized startups with grants of up to Rs. 60 lakhs each, along with a tailored 18-month incubation program delivered by Social Alpha
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