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Zydus Cadila gets USFDA’s final nod for Carbamazepine Extended-Release Tablets

08 Feb 2019 Evaluate

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Carbamazepine Extended-Release Tablets USP (US RLD - Tegretol XR), 100 mg, 200 mg, and 400 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad in the state of Gujarat.

Carbamazepine is an anticonvulsant agent. It works by reducing excessive nerve signals in the brain and restoring the normal balance of nerve activity. This medication is used to treat certain types of seizures (partial, generalized tonic-clonic, mixed) and certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

The group now has 248 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

Peers
Company Name CMP
Sun Pharma. Inds. 1864.00
Dr. Reddys Labs. 1140.80
Cipla 1380.00
Lupin 2075.00
Zydus Lifesciences 1118.00
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