The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
Once the unit is made fully functional, it will help the company in increasing its API and intermediate production capacity
The observation is procedural in nature and the company will address the observation within stipulated timelines.
He has over 23 years' experience working in leading companies such as Omniactive Health Technologies, Johnson Matthey Chemicals, BASF, Godrej Agrovet Limited & Bharat Petroleum Corporation Limited.
The company's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track
Indigenously-developed molecular diagnostics have helped expand the reach of diagnosis to every part of the country today
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