Drug Approval | July 08, 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
Company provides anticipated impact to second quarter 2022 financial results due to recently completed business development transactions
Company is investing more than €100 million in the expansion of the Halle site
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
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Meets the growing need for US-based API solubility and bioavailability enhancement services
The total covered market size of four brands – Z&D, Pediclory, Pecef & Ezinapi combined is Rs 1800 crores
105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world
The research here will mainly concentrate on the manufacturing process of biopharmaceuticals, especially in the area of advanced medicines, as well as the fermentation-based manufacture of ingredients for foods and food supplements
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