Janssen Pharmaceutica Nv, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE, with a corresponding US DMF Number 23824.
Remarkably, this DMF maintains an Active status since its submission on July 19, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2013, and payment made on December 26, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II