This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
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
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
The CRL did not identify any outstanding scientific issues with the product.
On the Capex front, the company has invested Rs. 416 crore in the first half and it is broadly in line with our guidance for the two years around Rs. 2,000 crore across all the subsidiaries and divisions
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
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