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.
 "Alembic Pharma zooms 20% as USFDA gives nod for anti-depression drug")
premium
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.
“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.
One subscription. Two world-class reads.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
SAVE 25%