Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator for manufacturing Doxycycline Injection at its Jarod facility, in Gujarat. Doxycycline Injection is used to treat or prevent bacterial infections, including pneumonia and other respiratory tract infections. “Zydus Cadila has received approval for its supplemental abbreviated new drug application (SANDA) for Doxycycline Injection USP, 100 mg/Vial from the US Food and Drug Administration (USFDA),” Zydus Cadila said in a statement.
The product will be manufactured at Cadila Healthcare Ltd’s injectable facility at Jarod, Vadodara (formerly known as Liva Pharmaceuticals Ltd), it added.
The company said the Jarod facility in Gujarat is an important one for Zydus’ US injectable portfolio as five abbreviated new drug applications (ANDAs) have been approved from this facility and another six have been filed, awaiting approval.
“Zydus has plans to file further ANDAs and NDAs from this facility.
This approval will also help ramp up site transfer approvals from the Moraiya facility (Ahmedabad) to this facility,” the company added.
The Zydus Group now has 293 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04, the company said.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 355.60 apiece on BSE, up 0.37 per cent against their previous close.