Drug Approval | July 14, 2023
Granules India announces approval for Acetaminophen and Ibuprofen Tablets
This product will be launched through Granules Consumer Health (GCH) division
This product will be launched through Granules Consumer Health (GCH) division
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
Granules India sponsored an initiative to ignite a drug-free revolution and contribute towards an empowered society
Granules now has a total of 58 ANDA approvals from US FDA
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
The facility is over 79,000 square feet and is equipped with packaging lines
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
The company will respond to these observations within the stipulated time period.
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