Alembic Pharma zooms 20% as USFDA gives nod for anti-depression drug

The stock is locked in upper circuit of 20% at Rs 522 after the company received approval from the USFDA for its ANDA Bupropion hydrochloride tablets USP, 75 mg and 100 mg.

Shares of Alembic Pharmaceuticals are locked in upper circuit of 20% at Rs 522 per share on the BSE after the company said that it has received approval from the US drug health regulator for anti-depression drug.

“The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bupropion hydrochloride tablets USP, 75 mg and 100 mg,” Alembic Pharma said in a press release.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Wellbutrin tablets, 75 mg and 100 mg, of GlaxoSmithKline LLC. Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder.

According to IMS, Bupropion hydrochloride tablets USP, 75 mg and 100 mg, have an estimated market size of US$ 37 million for twelve months ending December 2017.

Alembic Pharma said it has now a total of 72 ANDA approvals (64 final approvals and 8 tentative approvals) from USFDA.

Till 01:00 PM; a combined 536,880 equity shares changed hands and there were pending buy orders for 44,446 shares on the BSE and NSE.