USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
Glucagon is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
The company is addressing these observations comprehensively
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva
Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab
Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% and 0.06% are bioequivalent to Atrovent Nasal Spray, 0.03% and 0.06%, of Boehringer Ingelheim Pharmaceuticals
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