20
Alembic Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ERLOTINIB HYDROCHLORIDE, with a corresponding US DMF Number 30392.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 27, 2016, and payment made on March 22, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II