News | June 14, 2021
Lupin receives warning letter from U.S. FDA
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Emtricitabine and Tenofovir Disoproxil Fumarate tablets had estimated annual sales of US $2.1 billion in the U.S. according to IQVIA MAT March 2021
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
ranules now has a total of 38 ANDA approvals from US FDA.
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