News | July 21, 2021
Granules clears US FDA audit
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
Vikas Lifecare has already paid Rs. 25 million to the Advik bankers till date and the remaining amount shall also be paid within July 2021, making Advik a debt free company
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
In addition to supporting the ongoing development of the first IND-approved product in clinical trials, the proceeds will also be used to expand the 3D printed drug product pipeline
According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana
Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina
The company recorded revenue of Rs 528crore as compared to Rs 444 crore, registering a growth of 19% over the corresponding quarter ended 31st March 2020
The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination
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