Jubilant Life Sciences gets USFDA nod for Donepezil Hydrochloride

06 Jun 2011 Evaluate

Jubilant Life Sciences has received approval from the US Food and Drug Administration (USFDA) for Donepezil Hydrochloride Tablets 5 mg and 10 mg, a generic equivalent of Aricept.

Donepezil Hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type, in patients with mild, moderate and severe Alzheimer’s disease. The total annual market sales for Aricept 5 mg and 10 mg tablets were $2.6 billion.

Donepezil Hydrochloride Tablets will be manufactured at the company’s state of the art dosage form facility at Roorkee in India, with backward integration into the API manufactured at the company’s USFDA approved API facility at Nanjangud in India. The product will be marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc. under its label. With this approval Jubilant Cadista will have 15 commercialized products in the US market.

The company along with its subsidiary Cadista currently holds 17 ANDA approvals and has a pipeline of 19 ANDAs awaiting approvals from the US FDA.

Jubilant Life Sciences is an integrated Pharma and Life Sciences Company. It is the largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solution (DDDS) provider out of India.

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