USFDA inspection at Alembic Pharma's Bioequivalence facility
Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
Company expects to begin building four more domestic manufacturing sites this year and add 13,000 high-wage manufacturing and construction jobs in America
The PIPE offering consists of 36,190,476 units
The observations issued are neither repeated observations nor related to data integrity
USFDA inspection at Emcure Pharmaceuticals API facility
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
Subscribe To Our Newsletter & Stay Updated