Aurobindo Pharma subsidiary’s plant gets one observation from US FDA
The plant is owned by Aurolife Pharma, a wholly-owned step down subsidiary of the company
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Browsing Tag
US FDA
Glenmark, Strides Pharma and Cipla recall products in US
The recall has taken place due to manufacturing issues
US FDA orders Pfizer to test second Paxlovid course for rebound COVID patients
The drugmaker must produce initial results of a randomised controlled trial of a second course of the antiviral by 30th September…
US FDA issues Form 483 to Cipla’s facility in MP
The FDA has censured the drug maker due to unclean equipment and lack of data
US FDA accepts New Drug Application for GSK’s momelotinib for treatment of myelofibrosis
Regulatory submission included data from the pivotal Momentum phase-III clinical trial that met all primary and key secondary…
US FDA says possible carcinogen found in some Merck diabetes drugs
The agency said it would temporarily allow Merck to distribute drugs with sitagliptin containing a higher than normally acceptable…
Glenmark gets US FDA nod for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous…
These capsules are given to prevent pregnancy
GSK gets US FDA nod for Benlysta (Belimumab) to treat paediatric patients with active lupus…
Benlysta is now the first and only biologic approved for adults and children who have lupus or lupus nephritis
Zenara Pharma gets CDSCO nod to make and market generic version of Pfizer’s Paxlovid
The tablet, which will be sold under the brand name ‘Paxzen’, is being manufactured at Zenara’s US FDA approved facility in…