The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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.
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
Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
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