Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug
The stability is led by healthy demand in the domestic and emerging markets
ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
Going forward, the fastest-growing regions in the generic pharmaceuticals market will be South America and the Middle East, where growth will be at CAGRs of 10.1% and 9.4% respectively
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Second interchangeable biosimilar product approved by agency
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
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