The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
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
The audit is a pre-approval inspection for three products filed from the facility
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