Drug Approval | August 17, 2021
Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
'Unit-9' for manufacturing Gabapentin & other pharma (APIs) products is expected to be complete in Q3FY22
Anti-malaria API facility will be operational in 15-18 months
India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.
Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg
It is part of the company’s pain/analgesics portfolio of OTC products
The govt has rolled out three schemes for promoting the manufacture of API
The company has an outlay of Rs 120-140 crore as R & D expense for FY 22
The first six batches are being shipped to the Gamaleya Center, Moscow for the quality approval
The company is confident of commencing production at both Mahad and Chiplun units soon
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