Zydus receives USFDA SANDA approval for Doxycycline Injection

Zydus Cadila has received approval for its supplemental Abbreviated New Drug Application (SANDA) for Doxycycline Injection USP, 100 mg/Vial from the US FDA. The product will be manufactured at Cadila Healthcare injectable facility at Jarod, Vadodara (formerly known as Liva Pharmaceuticals). The state-of-the-art facility is equipped with manufacturing lines that can handle both liquid and lyophilised products based on vials and cartridges presentation.

Doxycycline USP is the first product approval at the second combined Liquid plus Lyophilised Vials Injectable line at the Jarod facility. This facility is an important one for Zydus' US Injectable portfolio as five 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 to this facility.

The group now has 293 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

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