Granules India Gets USFDA Nod for Generic Depression Drug
By Rediff Money Desk, New Delhi Oct 18, 2024 13:40
Granules India has received USFDA approval to market a generic medication for major depressive disorder, Bupropion Hydrochloride extended-release tablets USP (SR), expanding its presence in the US market.
New Delhi, Oct 18 (PTI) Drug maker Granules India on Friday said it has received approval from the US health regulator to market a generic medication to treat major depressive disorder.
The company has received approval from the US Food & Drug Administration (USFDA) for Bupropion Hydrochloride extended-release tablets USP (SR) in strength of 100 mg, 150 mg, and 200 mg, the Hyderabad-based drug maker said in a statement.
The abbreviated new drug application (ANDA) for the product was filed with the USFDA by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, it added.
Bupropion Hydrochloride extended-release tablets USP (SR) are bioequivalent and therapeutically equivalent to GlaxoSmithKline LLC's Wellbutrin SR sustained-release tablets, Granules India said.
The medication is widely prescribed for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.
Granules said it has now a total of 67 ANDA approvals from the USFDA.
"This ANDA approval marks a significant milestone in our journey to expand the company's presence in the US market," Granules India Chairman and Managing Krishna Prasad Chigurupati stated.
The company's continued focus on expanding product portfolio in regulated markets like the US ensures that it is meeting the growing healthcare needs of patients globally, he added.
Shares of Granules India were trading 0.72 per cent up at Rs 597.55 apiece on the BSE.
The company has received approval from the US Food & Drug Administration (USFDA) for Bupropion Hydrochloride extended-release tablets USP (SR) in strength of 100 mg, 150 mg, and 200 mg, the Hyderabad-based drug maker said in a statement.
The abbreviated new drug application (ANDA) for the product was filed with the USFDA by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, it added.
Bupropion Hydrochloride extended-release tablets USP (SR) are bioequivalent and therapeutically equivalent to GlaxoSmithKline LLC's Wellbutrin SR sustained-release tablets, Granules India said.
The medication is widely prescribed for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.
Granules said it has now a total of 67 ANDA approvals from the USFDA.
"This ANDA approval marks a significant milestone in our journey to expand the company's presence in the US market," Granules India Chairman and Managing Krishna Prasad Chigurupati stated.
The company's continued focus on expanding product portfolio in regulated markets like the US ensures that it is meeting the growing healthcare needs of patients globally, he added.
Shares of Granules India were trading 0.72 per cent up at Rs 597.55 apiece on the BSE.
Source: PTI
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- ARC Finance
- 1.34 (+ 4.69)
- 117414945
- Vodafone Idea L
- 7.77 (+ 4.02)
- 78706608
- Srestha Finvest
- 0.86 (+ 2.38)
- 39218412
- Franklin Industries
- 2.46 ( -4.65)
- 16530594
- G G Engineering
- 1.50 ( -0.66)
- 12389377
MORE NEWS
Maharashtra CM Launches Technical Textile...
Maharashtra CM Devendra Fadnavis announces the establishment of Maharashtra Technical...
SBI Life Invests in Bima Sugam India Federation
SBI Life has acquired a 10% stake in Bima Sugam India Federation, an insurance...
Sebi Allows Non-Convertible Securities...
Sebi has updated insider trading norms, permitting subscription to non-convertible...