Drug Approval | January 25, 2023
Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Granules now have a total of 53 ANDA approvals from USFDA
Granules now have a total of 53 ANDA approvals from USFDA
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
The company will not receive any proceeds from the offer as all of it will go to the promoter selling shareholder.
The company has been issued ‘Form 483’ with two observations
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
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