In a statement filed with the Bombay Stock Exchange (BSE) on Tuesday, Alembic informed that it has received USFDA approval for its new drug application (NDA), desvenlafaxine base extended release tablets.
The company is the sponsor and manufacturer of the NDA. Desvenlafaxine base extended release tablets is a prescription medicine and it is Alimbic's first 505 (B) (2) filing. The product is indicated for the treatment of major depressive disorder.
"The company has entered into an out-licensing arrangement with Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Limited for exclusively marketing the product in the US market," the statement said.
The product will be available in 50 mg and 100 mg disage strengths. The product will be launched immediately.
As per the industry data, the current market size for Pristiq is approximately US $ 538 million (approx. Rs 2900 crore).
The company shares closed positive with gain of over 2.5 per cent at Rs 16.05 on BSE today.