This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
The MUSE system offers a minimally invasive solution for treating gastroesophageal reflux disease
Most recently, Yuvraj was the Director of Operations, Business Development & Process Excellence at Zeon Lifesciences Ltd
Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
The proposed transaction will be effected as a share swap
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
These certifications reflect the company's continuous commitment to maintaining international standards of environmental sustainability as well as occupational health and safety
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