Lupin receives US FDA approval for Divalproex Sodium ER Tablets USP
The approval is for marketing 250 mg and 500 mg tablets
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Browsing Tag
Lupin
Lupin’s Nagpur facility receives EIR from the US FDA
The inspection for the oral solid facility at Nagpur closed without any Form 483 observation
Japan’s PMDA issues GMP Certificate to Lupin’s Mandideep facility
The certificate is valid till September 2024
Lupin announced the receipt of GMP (Good Manufacturing Practice) Certificate from…
Lupin launches Mycophenolate Mofetil Capsules USP
Mycophenolate Mofetil Capsules USP, 250 mg, is the generic version of Roche’s CellCept
Lupin Appoints Johnny Mikell as Global Head of Quality
Johnny will be based out of Lupin’s US offices and will lead the Company’s Quality function globally
Lupin appoints Sreeji Gopinathan as Chief Information Officer
Sreeji holds a Master’s degree in Business Administration from the University of Edinburgh, UK and B Tech (Applied Electronics and…
Lupin gets 3 observations from USFDA for its Tarapur facility
The inspection of Tarapur facility was carried out by the United States Food and Drug administration (USFDA) between September…
Lupin appoints Jon Stelzmiller as President of US Specialty Business
He brings to Lupin over 30 years of experience in the specialty segment, and will be replacing Nicholas Hart
Lupin gets warning letter from US FDA for Mandideep facility
Lupin said there are no drug master file and abbreviated new drug applications (ANDA) pending review or approval from the…
Lupin receives US FDA approval for Fosaprepitant Injection
The drug is indicated for the prevention of acute and delayed nausea and vomiting
Lupin has received approval for its…