Drug Approval | November 09, 2022
Lupin receives tentative approval from USFDA for Doxycycline Capsules
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
The acquisition of these two brands expands Lupin's portfolio of inhalation products in the U.S.
Through this agreement, Lupin will introduce two new formulations, a fixed-dose combination of Rifapentine + Isoniazid and Rifapentine 300 mg standalone tablets, at an affordable price
Dr. Fesharaki most recently served as the Chief Scientific Officer and Global Head of R&D for Hikma Pharmaceuticals.
The product will be manufactured at Lupin's facility in Nagpur, India.
The inspection of the facility was conducted from August 16-19, 2022.
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