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
Agreement further expands Aptar Pharma’s leading position in nasal delivery solutions and addresses significant unmet needs of delivering drugs locally over extended periods
Argo will receive an upfront payment of $160 million, an option for Profit & Loss split across multiple geographies and potential near-term equity
The company has received approval from DCGI to begin patient enrolment and dosing in the country
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
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
The U.S. FDA issued a Form 483 with five observations
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