01 1IWAKI SEIYAKU
01 1PHENYLEPHRINE HCL
01 1Japan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-12
DMF Number : 8140
Submission : 1989-07-07
Status : Active
Type : II
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Spera Nexus Inc, based in Japan, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is PHENYLEPHRINE HCL, with a corresponding US DMF Number 8140.
Remarkably, this DMF maintains an Active status since its submission on July 07, 1989, 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 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
