01 1IWAKI SEIYAKU
01 1PILOCARPINE HYDROCHLORIDE
01 1Japan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-17
DMF Number : 12388
Submission : 1997-02-21
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 PILOCARPINE HYDROCHLORIDE, with a corresponding US DMF Number 12388.
Remarkably, this DMF maintains an Active status since its submission on February 21, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2017, and payment made on May 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
