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News about "Granules Pharma "
Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR
The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.
Granules Pharma | 09/01/2026 | By News Bureau
Granules Pharma Gets US FDA Tentative Approval for Generic ADZENYS XR-ODT
Granules Pharmaceuticals Inc has received tentative approval from the US FDA for its generic version of Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT), which will be manufactured at the company’s US-based facility in Chantilly, Virginia.
Granules Pharma | 22/12/2025 | By News Bureau | 102
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