Tag: Granules India

Granules secures FTF status for CNS depressant generic

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Granules secures FTF status for CNS depressant generic

Granules said the sole FTF designation strengthens the company’s position in the complex generics segment and demonstrates its growing capabilities in developing and advancing complex, differentiated generic products for the U.S market. File | Photo Credit: The Hindu Granules India has secured sole first-to-file (FTF) status for its abbreviated new drug application (ANDA) for Sodium…

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Granules’ generic for ADHD secures U.S. FDA tentative nod

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Granules’ generic for ADHD secures U.S. FDA tentative nod

The U.S. FDA approval further strengthens the U.S. generics portfolio of the Granules’, says the company’s CMD. File | Photo Credit: Reuters Granules India, through a subsidiary, has received U.S. Food and Drug Administration’s (FDA’s) tentative approval for its generic of attention deficit hyperactivity disorder drug Adzenys-XR-ODT. The product, indicated for the treatment of ADHD,…

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Granules Life Sciences secures first U.S. FDA approval

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Granules Life Sciences secures first U.S. FDA approval

“We plan on launching the product in the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval,” Granules India CMD Krishna Prasad Chigurupati said in a release.  | Photo Credit: Photo Courtesy: www.linkedin.com/in/krishna-prasad-chigurupati Generic drugmaker Granules India subsidiary Granules Life Sciences…

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