Tag: lupin

U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

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Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for treatment of human immunodeficiency virus infection in […]

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Lupin gets U.S. FDA nod for two generic diabetes drugs 

Lupin gets U.S. FDA nod for two generic diabetes drugs 

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Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company’s injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen […]

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U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Lupin, China’s SUP ink pact for COPD drug Tiotropium DPI

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Lupin has signed a license and supply agreement with Sino Universal Pharmaceuticals (SUP) for commercialisation of chronic obstructive pulmonary disease drug Tiotropium Dry Powder Inhaler, 18 mcg/capsule, in the Chinese market. Under the partnership that will enable Lupin to expand footprint in China, SUP will obtain regulatory approvals for selling Tiotropium DPI in China. Lupin […]

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Lupin recalls hypertension drug Quinapril tablets in U.S.

Lupin recalls hypertension drug Quinapril tablets in U.S.

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While nitrosamines are common in water and various foods, these impurities may increase risk of cancer if people are exposed to them above acceptable levels over long periods of time, the company said. | Photo Credit: Reuters Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril tablets in the U.S. to the patient level. […]

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