Orchid Pharma shares rallied more than 8% on Thursday, June 6, after the company said it has received approval from the Drugs Controller General of India (DCGI) to market its antibiotic drug combination for treating complicated urinary tract infection (UTI).
In a stock exchange filing, the pharma company said DCGI has approved the manufacturing and marketing of the company’s first invented new chemical entity (NCE) active pharmaceutical ingredient (API) - Enmetazobactam.
The country’s apex drug regulator has also given its approval for the manufacturing and marketing of finished dosage form (FDF) of the Antibiotic Drug Combination of Cefepime and Enmetazobactam, which is made in India and will be used as a dry powder injectable, the company informed the stock exchanges.
"This is a beta-lactamase inhibitor, which goes with the antibiotics, and we are happy to announce that we have got the approval for this new inventor molecule which was invented by Orchid a few years back and a combination drug involving Enmetazobactam along with an antibiotic called Cefepime," Manish Dhanuka of Orchid Pharma told CNBC-TV18.
He added that they will now go to the state licensing authorities to give them the manufacturing licences, following which the company will begin production. "I expect I expect this to take about two months’ time and we hope to launch it in the month of August.,"Dhanuka said.
The company said that the formulation will be used to treat complicated Urinary Tract Infections (cUTI), which includes acute Pyelonephritis, HospitalAcquired Pneumonia (HAP), along with ventilator-associated pneumonia (VAP) and Bacteremia.
After the announcement, shares of Orchid Pharma rallied to hit an intraday high of ₹1,090.50 apiece on the BSE in the afternoon trade around 1:50 pm.
Following the DCGI approval, Orchid Pharma looks forward to improving the treatment landscape for serious infections in India, thereby providing access to advanced and effective therapy options to patients, it said.
“Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India,” Dhanuka said.
In a stock exchange filing, the pharma company said DCGI has approved the manufacturing and marketing of the company’s first invented new chemical entity (NCE) active pharmaceutical ingredient (API) - Enmetazobactam.
The country’s apex drug regulator has also given its approval for the manufacturing and marketing of finished dosage form (FDF) of the Antibiotic Drug Combination of Cefepime and Enmetazobactam, which is made in India and will be used as a dry powder injectable, the company informed the stock exchanges.
"This is a beta-lactamase inhibitor, which goes with the antibiotics, and we are happy to announce that we have got the approval for this new inventor molecule which was invented by Orchid a few years back and a combination drug involving Enmetazobactam along with an antibiotic called Cefepime," Manish Dhanuka of Orchid Pharma told CNBC-TV18.
He added that they will now go to the state licensing authorities to give them the manufacturing licences, following which the company will begin production. "I expect I expect this to take about two months’ time and we hope to launch it in the month of August.,"Dhanuka said.
The company said that the formulation will be used to treat complicated Urinary Tract Infections (cUTI), which includes acute Pyelonephritis, HospitalAcquired Pneumonia (HAP), along with ventilator-associated pneumonia (VAP) and Bacteremia.
After the announcement, shares of Orchid Pharma rallied to hit an intraday high of ₹1,090.50 apiece on the BSE in the afternoon trade around 1:50 pm.
Following the DCGI approval, Orchid Pharma looks forward to improving the treatment landscape for serious infections in India, thereby providing access to advanced and effective therapy options to patients, it said.
“Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India,” Dhanuka said.
First Published: Jun 6, 2024 2:46 PM IST
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!
