Orchid gets USFDA nod to launch Terbinafine
Orchid Chemicals and Pharmaceuticals Ltd on Friday said it has received tentative approval from US Food and Drug Administration.
By PTI |
MUMBAI: Tamil Nadu-based pharmaceutical firm Orchid Chemicals and Pharmaceuticals Ltd on Friday said it has received tentative approval from US Food and Drug Administration (USFDA) to launch Terbinafine HCL, used for treatment of fungal infections, in that country.
Orchid said it has received its first Abbreviated New Drug Application (ANDA) approval for Terbinafine 250 mg in the non-penicillin, noncephalosporin (NPNC) space and would be launching the product in the US, the company said in a communique to the Bombay Stock Exchange (BSE).
"We are happy about our first non-antibiotic product approval. Based on this timely approval, we will be launching the product in the US and hope to garner a good market share and revenues given the market standing of our distribution partner," Orchid Chemicals Managing Director K Raghavendra Rao said.
The company plans to launch the product in the US through its distribution partner Actavis after patent expiry on June 30.
Terbinafine has a current US retail market size of 650 million dollar and is AB-rated generic equivalent of Novartis's Lamisil Tablets.
This approval would mark the foray of the company into the non-antibiotic generic formulations segment.
"Though, the non-antibiotic space is relatively more crowded than the antibiotic product space, we are focusing on a niche product basket involving stringent development and manufacturing challenges will help in a better market presence," Rao added.
Shares of the company were last trading 0.46 per cent down at Rs 248.85 on the BSE.
Orchid said it has received its first Abbreviated New Drug Application (ANDA) approval for Terbinafine 250 mg in the non-penicillin, noncephalosporin (NPNC) space and would be launching the product in the US, the company said in a communique to the Bombay Stock Exchange (BSE).
"We are happy about our first non-antibiotic product approval. Based on this timely approval, we will be launching the product in the US and hope to garner a good market share and revenues given the market standing of our distribution partner," Orchid Chemicals Managing Director K Raghavendra Rao said.
The company plans to launch the product in the US through its distribution partner Actavis after patent expiry on June 30.
Terbinafine has a current US retail market size of 650 million dollar and is AB-rated generic equivalent of Novartis's Lamisil Tablets.
This approval would mark the foray of the company into the non-antibiotic generic formulations segment.
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"Though, the non-antibiotic space is relatively more crowded than the antibiotic product space, we are focusing on a niche product basket involving stringent development and manufacturing challenges will help in a better market presence," Rao added.
Shares of the company were last trading 0.46 per cent down at Rs 248.85 on the BSE.
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