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Browsing Tag
Mylan
USFDA restricts imports of 11 Viatris drugs made in Indore facility
It makes exceptions, subject to certain conditions, for four products based on shortage concerns
Manufacturing capacity of Remdesivir ramped up to around 1.19 cr crore vials a month: Govt
With the accelerated approval of 38 additional manufacturing sites, the number of approved manufacturing sites of remdesivir in…
Ramp up remdesivir manufacturing to full capacity: Govt to pharma firms
Mansukh Mandaviya said seven manufacturers - Mylan, Hetero, Jubiliant Life Sciences, Cipla, Dr Reddy's, Zydus Cadila and Sun…
Mylan-UpJohn merger as Viatris provides opportunity to focus on biosimilar launch and uptake
Following the news that the European Medicines Agency (EMA) has approved Kixelle, Biocon/Mylan’s biosimilar of Novo Nordisk’s…
USFDA defers action on BLA for Avastin biosimilar, notifies Biocon Biologics, Mylan
To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the…
Biocon Biologics, Mylan get CHMP recommendation for approval of biosimilar insulin Aspart
The European Commission decision on the approval is expected early next year
Mylan to acquire thrombosis business in Europe from Aspen Pharmacare for EUR 641.9 mn
Transaction expected to be immediately accretive to Mylan upon closing and is anticipated to be accretive to VIATRIS
US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
Biocon Biologics and Mylan launch Semglee (insulin glargine injection) in US
Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3ml pens and $98.65 per 10ml vial