Drug Approval | October 31, 2022
USFDA issues Form-483 for Lupin's Nagpur Unit-2
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for 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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Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
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