Antibioticos Do Brasil Ltda, based in Brazil, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is CEFEPIME FOR INJECTION USP (STERILE BULK), with a corresponding US DMF Number 19806.
Remarkably, this DMF maintains an Active status since its submission on September 26, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2013, and payment made on June 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II