IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr
The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA
The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Revenue is up 23% whereas Profit After Tax expands 29% for the company
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
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
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.
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