Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements
Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).
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
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
A long waiting period for critical equipment and a 50% hike in the cost of APIs imported from China are among the immediate challenges
India’s dependency on China for pharma intermediates can change if there is a proper coordination between educational institutes, research institutes and pharma manufacturers
Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg
The scheme incentivizes the manufacturing of patented drugs and other high value drugs at an incentive rate of 10% of incremental sales
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