Drug Approval | December 20, 2023
Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Lacosamide is indicated to treat partial-onset seizures
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The company is assessing the situation and simultaneously undertaking all the requisite action
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
Equipped with most advanced Distributed Control System (DCS) automation technology, the facility has been set up with an investment of Rs. 200 crore
The inspection of the facility conducted from August 7 to August 11, 2023
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