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Granules India seeks first mover advantage | Photo Credit: The Hindu Generic drugmaker Granules India has filed a Paragraph IV certification with the U.S. Food and Drug Administration (U.S. FDA) in connection with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets. Based on the timing and status of its ANDA and Paragraph IV…
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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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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“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…
Read More “Granules Life Sciences secures first U.S. FDA approval” »
